Method of hub communication with surgical instrument systems

ABSTRACT

A method for adjusting the operation of a clip applier using machine learning in a surgical suite is disclosed. The method comprises gathering data during surgical procedures, wherein the surgical procedures include the use of a clip applier comprising a crimping drive configured to be mechanically advanced through a crimping stroke. The method further comprises analyzing the gathered data to determine an appropriate operational adjustment of the clip applier and adjusting the operation of the clip applier to improve the operation of the clip applier.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional PatentApplication Ser. No. 62/659,900, entitled METHOD OF HUB COMMUNICATION,filed Apr. 19, 2018, the disclosure of which is incorporated byreference herein in its entirety. This application claims the benefit ofU.S. Provisional Patent Application Ser. No. 62/665,128, entitledMODULAR SURGICAL INSTRUMENTS, filed May 1, 2018, of U.S. ProvisionalPatent Application Ser. No. 62/665,129, entitled SURGICAL SUTURINGSYSTEMS, filed May 1, 2018, of U.S. Provisional Patent Application Ser.No. 62/665,134, entitled SURGICAL CLIP APPLIER, filed May 1, 2018, ofU.S. Provisional Patent Application Ser. No. 62/665,139, entitledSURGICAL INSTRUMENTS COMPRISING CONTROL SYSTEMS, filed May 1, 2018, ofU.S. Provisional Patent Application Ser. No. 62/665,177, entitledSURGICAL INSTRUMENTS COMPRISING HANDLE ARRANGEMENTS, filed May 1, 2018,and of U.S. Provisional Patent Application Ser. No. 62/665,192, entitledSURGICAL DISSECTORS, filed May 1, 2018, the disclosures of which areincorporated by reference herein in their entireties. This applicationclaims the benefit of U.S. Provisional Patent Application Ser. No.62/649,291, entitled USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TODETERMINE PROPERTIES OF BACK SCATTERED LIGHT, filed Mar. 28, 2018, ofU.S. Provisional Patent Application Ser. No. 62/649,294, entitled DATASTRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND CREATE ANONYMIZEDRECORD, filed Mar. 28, 2018, of U.S. Provisional Patent Application Ser.No. 62/649,296, entitled ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICALDEVICES, filed Mar. 28, 2018, of U.S. Provisional Patent ApplicationSer. No. 62/649,300, entitled SURGICAL HUB SITUATIONAL AWARENESS, filedMar. 28, 2018, of U.S. Provisional Patent Application Ser. No.62/649,302, entitled INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTEDCOMMUNICATION CAPABILITIES, filed Mar. 28, 2018, of U.S. ProvisionalPatent Application Ser. No. 62/649,307, entitled AUTOMATIC TOOLADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS, filed Mar. 28, 2018,of U.S. Provisional Patent Application Ser. No. 62/649,309, entitledSURGICAL HUB SPATIAL AWARENESS TO DETERMINE DEVICES IN OPERATINGTHEATER, filed Mar. 28, 2018, of U.S. Provisional Patent ApplicationSer. No. 62/649,310, entitled COMPUTER IMPLEMENTED INTERACTIVE SURGICALSYSTEMS, filed Mar. 28, 2018, of U.S. Provisional Patent ApplicationSer. No. 62/649,313, entitled CLOUD INTERFACE FOR COUPLED SURGICALDEVICES, filed Mar. 28, 2018, of U.S. Provisional Patent ApplicationSer. No. 62/649,315, entitled DATA HANDLING AND PRIORITIZATION IN ACLOUD ANALYTICS NETWORK, filed Mar. 28, 2018, of U.S. Provisional PatentApplication Ser. No. 62/649,320, entitled DRIVE ARRANGEMENTS FORROBOT-ASSISTED SURGICAL PLATFORMS, filed Mar. 28, 2018, of U.S.Provisional Patent Application Ser. No. 62/649,323, entitled SENSINGARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS, filed Mar. 28, 2018,of U.S. Provisional Patent Application Ser. No. 62/649,327, entitledCLOUD-BASED MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS ANDREACTIVE MEASURES, filed Mar. 28, 2018, and of U.S. Provisional PatentApplication Ser. No. 62/649,333, entitled CLOUD-BASED MEDICAL ANALYTICSFOR CUSTOMIZATION AND RECOMMENDATIONS TO A USER, filed Mar. 28, 2018,the disclosures of which are incorporated by reference herein in theirentireties. This application claims the benefit of U.S. ProvisionalPatent Application Ser. No. 62/611,339, entitled ROBOT ASSISTED SURGICALPLATFORM, filed Dec. 28, 2017, of U.S. Provisional Patent ApplicationSer. No. 62/611,340, entitled CLOUD-BASED MEDICAL ANALYTICS, filed Dec.28, 2017, and of U.S. Provisional Patent Application Ser. No.62/611,341, entitled INTERACTIVE SURGICAL PLATFORM, filed Dec. 28, 2017,the disclosures of which are incorporated by reference herein in theirentireties. This application claims the benefit of U.S. ProvisionalPatent Application Ser. No. 62/578,793, entitled SURGICAL INSTRUMENTWITH REMOTE RELEASE, filed Oct. 30, 2017, of U.S. Provisional PatentApplication Ser. No. 62/578,804, entitled SURGICAL INSTRUMENT HAVINGDUAL ROTATABLE MEMBERS TO EFFECT DIFFERENT TYPES OF END EFFECTORMOVEMENT, filed Oct. 30, 2017, of U.S. Provisional Patent ApplicationSer. No. 62/578,817, entitled SURGICAL INSTRUMENT WITH ROTARY DRIVESELECTIVELY ACTUATING MULTIPLE END EFFECTOR FUNCTIONS, filed Oct. 30,2017, of U.S. Provisional Patent Application Ser. No. 62/578,835,entitled SURGICAL INSTRUMENT WITH ROTARY DRIVE SELECTIVELY ACTUATINGMULTIPLE END EFFECTOR FUNCTIONS, filed Oct. 30, 2017, of U.S.Provisional Patent Application Ser. No. 62/578,844, entitled SURGICALINSTRUMENT WITH MODULAR POWER SOURCES, filed Oct. 30, 2017, and of U.S.Provisional Patent Application Ser. No. 62/578,855, entitled SURGICALINSTRUMENT WITH SENSOR AND/OR CONTROL SYSTEMS, filed Oct. 30, 2017, thedisclosures of which are incorporated by reference herein in theirentireties.

BACKGROUND

The present disclosure relates to various surgical systems. Surgicalprocedures are typically performed in surgical operating theaters orrooms in a healthcare facility such as, for example, a hospital. Asterile field is typically created around the patient. The sterile fieldmay include the scrubbed team members, who are properly attired, and allfurniture and fixtures in the area. Various surgical devices and systemsare utilized in performance of a surgical procedure.

Furthermore, in the Digital and Information Age, medical systems andfacilities are often slower to implement systems or procedures utilizingnewer and improved technologies due to patient safety and a generaldesire for maintaining traditional practices. However, often timesmedical systems and facilities may lack communication and sharedknowledge with other neighboring or similarly situated facilities as aresult. To improve patient practices, it would be desirable to find waysto help interconnect medical systems and facilities better.

The present disclosure also relates to robotic surgical systems. Roboticsurgical systems can include a central control unit, a surgeon's commandconsole, and a robot having one or more robotic arms. Robotic surgicaltools can be releasably mounted to the robotic arm(s). The number andtype of robotic surgical tools can depend on the type of surgicalprocedure. Robotic surgical systems can be used in connection with oneor more displays and/or one or more handheld surgical instruments duringa surgical procedure.

The present invention also relates to surgical systems and, in variousarrangements, to grasping instruments that are designed to grasp thetissue of a patient, dissecting instruments configured to manipulate thetissue of a patient, clip appliers configured to clip the tissue of apatient, and suturing instruments configured to suture the tissue of apatient, among others.

BRIEF DESCRIPTION OF THE DRAWINGS

Various features of the embodiments described herein, together withadvantages thereof, may be understood in accordance with the followingdescription taken in conjunction with the accompanying drawings asfollows:

FIG. 1 is a block diagram of a computer-implemented interactive surgicalsystem, in accordance with at least one aspect of the presentdisclosure;

FIG. 2 is a surgical system being used to perform a surgical procedurein an operating room, in accordance with at least one aspect of thepresent disclosure;

FIG. 3 is a surgical hub paired with a visualization system, a roboticsystem, and an intelligent instrument, in accordance with at least oneaspect of the present disclosure;

FIG. 4 is a partial perspective view of a surgical hub enclosure, and ofa combo generator module slidably receivable in a drawer of the surgicalhub enclosure, in accordance with at least one aspect of the presentdisclosure;

FIG. 5 is a perspective view of a combo generator module with bipolar,ultrasonic, and monopolar contacts and a smoke evacuation component, inaccordance with at least one aspect of the present disclosure;

FIG. 6 illustrates individual power bus attachments for a plurality oflateral docking ports of a lateral modular housing configured to receivea plurality of modules, in accordance with at least one aspect of thepresent disclosure;

FIG. 7 illustrates a vertical modular housing configured to receive aplurality of modules, in accordance with at least one aspect of thepresent disclosure;

FIG. 8 illustrates a surgical data network comprising a modularcommunication hub configured to connect modular devices located in oneor more operating theaters of a healthcare facility, or any room in ahealthcare facility specially equipped for surgical operations, to thecloud, in accordance with at least one aspect of the present disclosure;

FIG. 9 illustrates a computer-implemented interactive surgical system,in accordance with at least one aspect of the present disclosure;

FIG. 10 illustrates a surgical hub comprising a plurality of modulescoupled to the modular control tower, in accordance with at least oneaspect of the present disclosure;

FIG. 11 illustrates one aspect of a Universal Serial Bus (USB) networkhub device, in accordance with at least one aspect of the presentdisclosure;

FIG. 12 illustrates a logic diagram of a control system of a surgicalinstrument or tool, in accordance with at least one aspect of thepresent disclosure;

FIG. 13 illustrates a control circuit configured to control aspects ofthe surgical instrument or tool, in accordance with at least one aspectof the present disclosure;

FIG. 14 illustrates a combinational logic circuit configured to controlaspects of the surgical instrument or tool, in accordance with at leastone aspect of the present disclosure;

FIG. 15 illustrates a sequential logic circuit configured to controlaspects of the surgical instrument or tool, in accordance with at leastone aspect of the present disclosure;

FIG. 16 illustrates a surgical instrument or tool comprising a pluralityof motors which can be activated to perform various functions, inaccordance with at least one aspect of the present disclosure;

FIG. 17 is a schematic diagram of a robotic surgical instrumentconfigured to operate a surgical tool described herein, in accordancewith at least one aspect of the present disclosure;

FIG. 18 illustrates a block diagram of a surgical instrument programmedto control the distal translation of a displacement member, inaccordance with at least one aspect of the present disclosure;

FIG. 19 is a schematic diagram of a surgical instrument configured tocontrol various functions, in accordance with at least one aspect of thepresent disclosure;

FIG. 20 is a simplified block diagram of a generator configured toprovide inductorless tuning, among other benefits, in accordance with atleast one aspect of the present disclosure;

FIG. 21 illustrates an example of a generator, which is one form of thegenerator of FIG. 20, in accordance with at least one aspect of thepresent disclosure;

FIG. 22 illustrates a combination generator, in accordance with at leastone aspect of the present disclosure;

FIG. 23 illustrates a method of capturing data from a combinationgenerator and communicating the captured generator data to a cloud-basedsystem, in accordance with at least one aspect of the presentdisclosure;

FIG. 24 illustrates a data packet of combination generator data, inaccordance with at least one aspect of the present disclosure;

FIG. 25 illustrates an encryption algorithm, in accordance with at leastone aspect of the present disclosure;

FIG. 26 illustrates another encryption algorithm, in accordance with atleast one aspect of the present disclosure;

FIG. 27 illustrates yet another encryption algorithm, in accordance withat least one aspect of the present disclosure;

FIG. 28 illustrates a high-level representation of a datagram, inaccordance with at least one aspect of the present disclosure;

FIG. 29 illustrates a more detailed representation of the datagram ofFIG. 28, in accordance with at least one aspect of the presentdisclosure;

FIG. 30 illustrates another representation of the datagram of FIG. 28,in accordance with at least one aspect of the present disclosure;

FIG. 31 illustrates a method of identifying surgical data associatedwith a failure event and communicating the identified surgical data to acloud-based system on a prioritized basis, in accordance with at leastone aspect of the present disclosure;

FIG. 32 illustrates yet another representation of the datagram of FIG.28, in accordance with at least one aspect of the present disclosure;

FIG. 33 illustrates a partial artificial timeline of a surgicalprocedure performed in an operating room via a surgical system, inaccordance with at least one aspect of the present disclosure;

FIG. 34 illustrates ultrasonic pinging of an operating room wall todetermine a distance between a surgical hub and the operating room wall,in accordance with at least one aspect of the present disclosure;

FIG. 35 is a logic flow diagram of a process depicting a control programor a logic configuration for surgical hub pairing with surgical devicesof a surgical system that are located within the bounds of an operatingroom, in accordance with at least one aspect of the present disclosure;

FIG. 36 is a logic flow diagram of a process depicting a control programor a logic configuration for selectively forming and severingconnections between devices of a surgical system, in accordance with atleast one aspect of the present disclosure;

FIG. 37 is a logic flow diagram of a process depicting a control programor a logic configuration for selectively reevaluating the bounds of anoperating room after detecting a new device, in accordance with at leastone aspect of the present disclosure;

FIG. 38 is a logic flow diagram of a process depicting a control programor a logic configuration for selectively reevaluating the bounds of anoperating room after disconnection of a paired device, in accordancewith at least one aspect of the present disclosure;

FIG. 39 is a logic flow diagram of a process depicting a control programor a logic configuration for reevaluating the bounds of an operatingroom by a surgical hub after detecting a change in the position of thesurgical hub, in accordance with at least one aspect of the presentdisclosure;

FIG. 40 is a logic flow diagram of a process depicting a control programor a logic configuration for selectively forming connections betweendevices of a surgical system, in accordance with at least one aspect ofthe present disclosure;

FIG. 41 is a logic flow diagram of a process depicting a control programor a logic configuration for selectively forming and severingconnections between devices of a surgical system, in accordance with atleast one aspect of the present disclosure;

FIG. 42 illustrates a surgical hub pairing a first device and a seconddevice of a surgical system in an operating room, in accordance with atleast one aspect of the present disclosure;

FIG. 43 illustrates a surgical hub unpairing a first device and a seconddevice of a surgical system in an operating room, and pairing the firstdevice with a third device in the operating room, in accordance with atleast one aspect of the present disclosure;

FIG. 44 is a logic flow diagram of a process depicting a control programor a logic configuration for forming an severing connections betweendevices of a surgical system in an operating room during a surgicalprocedure based on progression of the steps of the surgical procedure,in accordance with at least one aspect of the present disclosure;

FIG. 45 is a logic flow diagram of a process depicting a control programor a logic configuration for overlaying information derived from one ormore still frames of a livestream of a remote surgical site onto thelivestream, in accordance with at least one aspect of the presentdisclosure;

FIG. 46 is a logic flow diagram of a process depicting a control programor a logic configuration for differentiating among surgical steps of asurgical procedure, in accordance with at least one aspect of thepresent disclosure;

FIG. 47 is a logic flow diagram of a process 3230 depicting a controlprogram or a logic configuration for differentiating among surgicalsteps of a surgical procedure, in accordance with at least one aspect ofthe present disclosure;

FIG. 48 is a logic flow diagram of a process 3240 depicting a controlprogram or a logic configuration for identifying a staple cartridge frominformation derived from one or more still frames of staples deployedfrom the staple cartridge into tissue, in accordance with at least oneaspect of the present disclosure;

FIG. 49 is a partial view of a surgical system in an operating room, thesurgical system including a surgical hub that has an imaging module incommunication with an imaging device at a remote surgical site, inaccordance with at least one aspect of the present disclosure;

FIG. 50 illustrates a partial view of stapled tissue that received afirst staple firing and a second staple firing arranged end-to-end, inaccordance with at least one aspect of the present disclosure;

FIG. 51 illustrates three rows of staples deployed on one side of atissue stapled and cut by a surgical stapler, in accordance with atleast one aspect of the present disclosure;

FIG. 52 illustrates a non-anodized staple and an anodized staple, inaccordance with at least one aspect of the present disclosure;

FIG. 53 is a logic flow diagram of a process depicting a control programor a logic configuration for coordinating a control arrangement betweensurgical hubs, in accordance with at least one aspect of the presentdisclosure;

FIG. 54 illustrates an interaction between two surgical hubs in anoperating room, in accordance with at least one aspect of the presentdisclosure;

FIG. 55 is a logic flow diagram of a process depicting a control programor a logic configuration for coordinating a control arrangement betweensurgical hubs, in accordance with at least one aspect of the presentdisclosure;

FIG. 56 illustrates an interaction between two surgical hubs indifferent operating rooms (“OR1” and “OR3”), in accordance with at leastone aspect of the present disclosure;

FIG. 57 illustrates a secondary display in an operating room (“OR3”)showing a surgical site in a colorectal procedure, in accordance with atleast one aspect of the present disclosure;

FIG. 58 illustrates a personal interface or tablet in OR1 displaying thesurgical site of OR3, in accordance with at least one aspect of thepresent disclosure;

FIG. 59 illustrates an expanded view of the surgical site of OR3displayed on a primary display of OR1, in accordance with at least oneaspect of the present disclosure;

FIG. 60 illustrates a personal interface or tablet displaying a layoutof OR1 that shows available displays, in accordance with at least oneaspect of the present disclosure;

FIG. 61 illustrates a recommendation of a transection location of asurgical site of OR3 made by a surgical operator in OR1 via a personalinterface or tablet in OR1, in accordance with at least one aspect ofthe present disclosure;

FIG. 62 is a diagram illustrating a technique for interacting with apatient Electronic Medical Record (EMR) database, in accordance with atleast one aspect of the present disclosure;

FIG. 63 illustrates a process of anonymizing a surgical procedure bysubstituting an artificial time measure for a real time clock for allinformation stored internally within the instrument, robot, surgicalhub, and/or hospital computer equipment, in accordance with at least oneaspect of the present disclosure;

FIG. 64 illustrates ultrasonic pinging of an operating room wall todetermine a distance between a surgical hub and the operating room wall,in accordance with at least one aspect of the present disclosure;

FIG. 65 illustrates a diagram depicting the process of importing patientdata stored in an Electronic Medical Record (EMR) database, strippingthe patient data, and identifying smart device implications, inaccordance with at least one aspect of the present disclosure;

FIG. 66 illustrates the application of cloud based analytics to redactedand stripped patient data and independent data pairs, in accordance withat least one aspect of the present disclosure;

FIG. 67 is a logic flow diagram of a process depicting a control programor a logic configuration for associating patient data sets from firstand second sources of data, in accordance with at least one aspect ofthe present disclosure;

FIG. 68 is a logic flow diagram of a process depicting a control programor a logic configuration for stripping data to extract relevant portionsof the data to configure and operate the surgical hub and modules (e.g.,instruments) coupled to the surgical hub, in accordance with at leastone aspect of the present disclosure;

FIG. 69 illustrates a self-describing data packet comprisingself-describing data, in accordance with at least one aspect of thepresent disclosure;

FIG. 70 is a logic flow diagram of a process depicting a control programor a logic configuration for using data packets comprisingself-describing data, in accordance with at least one aspect of thepresent disclosure;

FIG. 71 is a logic flow diagram of a process depicting a control programor a logic configuration for using data packets comprisingself-describing data, in accordance with at least one aspect of thepresent disclosure;

FIG. 72 is a diagram of a tumor embedded in the right superior posteriorlobe of the right lung, in accordance with at least one aspect of thepresent disclosure;

FIG. 73 is a diagram of a lung tumor resection surgical procedureincluding four separate firings of a surgical stapler to seal and cutbronchial vessels exposed in the fissure leading to and from the upperand lower lobes of the right lung shown in FIG. 72, in accordance withat least one aspect of the present disclosure;

FIG. 74 is a graphical illustration of a force-to-close (FTC) versustime curve and a force-to-fire (FTF) versus time curve characterizingthe first firing of device 002 as shown in FIG. 72, in accordance withat least one aspect of the present disclosure;

FIG. 75 is a diagram of a staple line visualization laser Doppler toevaluate the integrity of staple line seals by monitoring bleeding of avessel after a firing of a surgical stapler, in accordance with at leastone aspect of the present disclosure;

FIG. 76 illustrates a paired data set grouped by surgery, in accordancewith at least one aspect of the present disclosure;

FIG. 77 is a diagram of the right lung;

FIG. 78 is a diagram of the bronchial tree including the trachea andbronchi of the lung;

FIG. 79 is a logic flow diagram of a process depicting a control programor a logic configuration for storing paired anonymous data sets groupedby surgery, in accordance with at least one aspect of the presentdisclosure;

FIG. 80 is a logic flow diagram of a process depicting a control programor a logic configuration for determining rate, frequency, and type ofdata to transfer to a remote cloud-based analytics network, inaccordance with at least one aspect of the present disclosure;

FIG. 81 illustrates a diagram of a situationally aware surgical system,in accordance with at least one aspect of the present disclosure;

FIG. 82A illustrates a logic flow diagram of a process for controlling amodular device according to contextual information derived from receiveddata, in accordance with at least one aspect of the present disclosure;

FIG. 82B illustrates a logic flow diagram of a process for controlling asecond modular device according to contextual information derived fromperioperative data received from a first modular device, in accordancewith at least one aspect of the present disclosure;

FIG. 82C illustrates a logic flow diagram of a process for controlling asecond modular device according to contextual information derived fromperioperative data received from a first modular device and the secondmodular device, in accordance with at least one aspect of the presentdisclosure;

FIG. 82D illustrates a logic flow diagram of a process for controlling athird modular device according to contextual information derived fromperioperative data received from a first modular device and a secondmodular device, in accordance with at least one aspect of the presentdisclosure;

FIG. 83A illustrates a diagram of a surgical hub communicably coupled toa particular set of modular devices and an Electronic Medical Record(EMR) database, in accordance with at least one aspect of the presentdisclosure;

FIG. 83B illustrates a diagram of a smoke evacuator including pressuresensors, in accordance with at least one aspect of the presentdisclosure;

FIG. 84A illustrates a logic flow diagram of a process for determining aprocedure type according to smoke evacuator perioperative data, inaccordance with at least one aspect of the present disclosure;

FIG. 84B illustrates a logic flow diagram of a process for determining aprocedure type according to smoke evacuator, insufflator, and medicalimaging device perioperative data, in accordance with at least oneaspect of the present disclosure;

FIG. 84C illustrates a logic flow diagram of a process for determining aprocedure type according to medical imaging device perioperative data,in accordance with at least one aspect of the present disclosure;

FIG. 84D illustrates a logic flow diagram of a process for determining aprocedural step according to insufflator perioperative data, inaccordance with at least one aspect of the present disclosure;

FIG. 84E illustrates a logic flow diagram of a process for determining aprocedural step according to energy generator perioperative data, inaccordance with at least one aspect of the present disclosure;

FIG. 84F illustrates a logic flow diagram of a process for determining aprocedural step according to energy generator perioperative data, inaccordance with at least one aspect of the present disclosure;

FIG. 84G illustrates a logic flow diagram of a process for determining aprocedural step according to stapler perioperative data, in accordancewith at least one aspect of the present disclosure;

FIG. 84H illustrates a logic flow diagram of a process for determining apatient status according to ventilator, pulse oximeter, blood pressuremonitor, and/or EKG monitor perioperative data, in accordance with atleast one aspect of the present disclosure;

FIG. 84I illustrates a logic flow diagram of a process for determining apatient status according to pulse oximeter, blood pressure monitor,and/or EKG monitor perioperative data, in accordance with at least oneaspect of the present disclosure;

FIG. 84J illustrates a logic flow diagram of a process for determining apatient status according to ventilator perioperative data, in accordancewith at least one aspect of the present disclosure;

FIG. 85A illustrates a scanner coupled to a surgical hub for scanning apatient wristband, in accordance with at least one aspect of the presentdisclosure;

FIG. 85B illustrates a scanner coupled to a surgical hub for scanning alist of surgical items, in accordance with at least one aspect of thepresent disclosure;

FIG. 86 illustrates a timeline of an illustrative surgical procedure andthe inferences that the surgical hub can make from the data detected ateach step in the surgical procedure, in accordance with at least oneaspect of the present disclosure;

FIG. 87A illustrates a flow diagram depicting the process of importingpatient data stored in an EMR database and deriving inferencestherefrom, in accordance with at least one aspect of the presentdisclosure;

FIG. 87B illustrates a flow diagram depicting the process of determiningcontrol adjustments corresponding to the derived inferences from FIG.87A, in accordance with at least one aspect of the present disclosure;

FIG. 88 illustrates a block diagram of a computer-implementedinteractive surgical system, in accordance with at least one aspect ofthe present disclosure;

FIG. 89 illustrates a logic flow diagram of tracking data associatedwith an operating theater event, in accordance with at least one aspectof the present disclosure;

FIG. 90 illustrates a diagram depicting how the data tracked by thesurgical hub can be parsed to provide increasingly detailed metrics, inaccordance with at least one aspect of the present disclosure;

FIG. 91 illustrates a bar graph depicting the number of patientsoperated on relative to the days of a week for different operatingrooms, in accordance with at least one aspect of the present disclosure;

FIG. 92 illustrates a bar graph depicting the total downtime betweenprocedures relative to the days of a week for a particular operatingroom, in accordance with at least one aspect of the present disclosure;

FIG. 93 illustrates a bar graph depicting the total downtime per day ofthe week depicted in FIG. 92 broken down according to each individualdowntime instance, in accordance with at least one aspect of the presentdisclosure;

FIG. 94 illustrates a bar graph depicting the average procedure lengthrelative to the days of a week for a particular operating room, inaccordance with at least one aspect of the present disclosure;

FIG. 95 illustrates a bar graph depicting procedure length relative toprocedure type, in accordance with at least one aspect of the presentdisclosure;

FIG. 96 illustrates a bar graph depicting the average completion timefor particular procedural steps for different types of thoracicprocedures, in accordance with at least one aspect of the presentdisclosure;

FIG. 97 illustrates a bar graph depicting procedure time relative toprocedure types, in accordance with at least one aspect of the presentdisclosure;

FIG. 98 illustrates a bar graph depicting operating room downtimerelative to the time of day, in accordance with at least one aspect ofthe present disclosure;

FIG. 99 illustrates a bar graph depicting operating room downtimerelative to the day of the week, in accordance with at least one aspectof the present disclosure;

FIG. 100 illustrates a pair of pie charts depicting the percentage oftime that the operating theater is utilized, in accordance with at leastone aspect of the present disclosure;

FIG. 101 illustrates a bar graph depicting consumed and unused surgicalitems relative to procedure type, in accordance with at least one aspectof the present disclosure;

FIG. 102 illustrates a logic flow diagram of a process for storing datafrom the modular devices and patient information database forcomparison, in accordance with at least one aspect of the presentdisclosure;

FIG. 103 illustrates a diagram of a distributed computing system, inaccordance with at least one aspect of the present disclosure;

FIG. 104 illustrates a logic flow diagram of a process for shiftingdistributed computing resources, in accordance with at least one aspectof the present disclosure;

FIG. 105 illustrates a diagram of an imaging system and a surgicalinstrument bearing a calibration scale, in accordance with at least oneaspect of the present disclosure;

FIG. 106 illustrates a diagram of a surgical instrument centered on alinear staple transection line using the benefit of centering tools andtechniques described in connection with FIGS. 107-119, in accordancewith at least one aspect of the present disclosure;

FIGS. 107-109 illustrate a process of aligning an anvil trocar of acircular stapler to a staple overlap portion of a linear staple linecreated by a double-stapling technique, in accordance with at least oneaspect of the present disclosure, where:

FIG. 107 illustrates an anvil trocar of a circular stapler that is notaligned with a staple overlap portion of a linear staple line created bya double-stapling technique;

FIG. 108 illustrates an anvil trocar of a circular stapler that isaligned with the center of the staple overlap portion of the linearstaple line created by a double-stapling technique; and

FIG. 109 illustrates a centering tool displayed on a surgical hubdisplay showing a staple overlap portion of a linear staple line createdby a double-stapling technique to be cut out by a circular stapler,where the anvil trocar is not aligned with the staple overlap portion ofthe double staple line as shown in FIG. 107;

FIGS. 110 and 111 illustrate a before image and an after image of acentering tool, in accordance with at least one aspect of the presentdisclosure, where:

FIG. 110 illustrates an image of a projected cut path of an anvil trocarand circular knife before alignment with the target alignment ringcircumscribing the image of the linear staple line over the image of thestaple overlap portion presented on a surgical hub display; and

FIG. 111 illustrates an image of a projected cut path of an anvil trocarand circular knife after alignment with the target alignment ringcircumscribing the image of the linear staple line over the image of thestaple overlap portion presented on a surgical hub display;

FIGS. 112-114 illustrate a process of aligning an anvil trocar of acircular stapler to a center of a linear staple line, in accordance withat least one aspect of the present disclosure, where:

FIG. 112 illustrates the anvil trocar out of alignment with the centerof the linear staple line;

FIG. 113 illustrates the anvil trocar in alignment with the center ofthe linear staple line; and

FIG. 114 illustrates a centering tool displayed on a surgical hubdisplay of a linear staple line, where the anvil trocar is not alignedwith the staple overlap portion of the double staple line as shown inFIG. 112;

FIG. 115 is an image of a standard reticle field view of a linear stapleline transection of a surgical as viewed through a laparoscope displayedon the surgical hub display, in accordance with at least one aspect ofthe present disclosure;

FIG. 116 is an image of a laser-assisted reticle field of view of thesurgical site shown in FIG. 115 before the anvil trocar and circularknife of the circular stapler are aligned to the center of the linearstaple line, in accordance with at least one aspect of the presentdisclosure;

FIG. 117 is an image of a laser-assisted reticle field of view of thesurgical site shown in FIG. 116 after the anvil trocar and circularknife of the circular stapler are aligned to the center of the linearstaple line, in accordance with at least one aspect of the presentdisclosure;

FIG. 118 illustrates a non-contact inductive sensor implementation of anon-contact sensor to determine an anvil trocar location relative to thecenter of a staple line transection, in accordance with at least oneaspect of the present disclosure;

FIGS. 119A and 119B illustrate one aspect of a non-contact capacitivesensor implementation of the non-contact sensor to determine an anviltrocar location relative to the center of a staple line transection, inaccordance with at least one aspect of the present disclosure, where:

FIG. 119A shows the non-contact capacitive sensor without a nearby metaltarget; and

FIG. 119B shows the non-contact capacitive sensor near a metal target;

FIG. 120 is a logic flow diagram of a process depicting a controlprogram or a logic configuration for aligning a surgical instrument, inaccordance with at least one aspect of the present disclosure;

FIG. 121 illustrates a primary display of the surgical hub comprising aglobal and local display, in accordance with at least one aspect of thepresent disclosure;

FIG. 122 illustrates a primary display of the surgical hub, inaccordance with at least one aspect of the present disclosure;

FIG. 123 illustrates a clamp stabilization sequence over a five secondperiod, in accordance with at least one aspect of the presentdisclosure;

FIG. 124 illustrates a diagram of four separate wide angle view imagesof a surgical site at four separate times during the procedure, inaccordance with at least one aspect of the present disclosure;

FIG. 125 is a graph of tissue creep clamp stabilization curves for twotissue types, in accordance with at least one aspect of the presentdisclosure;

FIG. 126 is a graph of time dependent proportionate fill of a clampforce stabilization curve, in accordance with at least one aspect of thepresent disclosure;

FIG. 127 is a graph of the role of tissue creep in the clamp forcestabilization curve, in accordance with at least one aspect of thepresent disclosure;

FIGS. 128A and 128B illustrate two graphs for determining when theclamped tissue has reached creep stability, in accordance with at leastone aspect of the present disclosure, where:

FIG. 128A illustrates a curve that represents a vector tangent angle dθas a function of time; and

FIG. 128B illustrates a curve that represents change in force-to-close(ΔFTC) as a function of time;

FIG. 129 illustrates an example of an augmented video image of apre-operative video image augmented with data identifying displayedelements, in accordance with at least one aspect of the presentdisclosure;

FIG. 130 is a logic flow diagram of a process depicting a controlprogram or a logic configuration to display images, in accordance withat least one aspect of the present disclosure;

FIG. 131 illustrates a communication system comprising an intermediatesignal combiner positioned in the communication path between an imagingmodule and a surgical hub display, in accordance with at least oneaspect of the present disclosure;

FIG. 132 illustrates an independent interactive headset worn by asurgeon to communicate data to the surgical hub, according to one aspectof the present disclosure;

FIG. 133 illustrates a method for controlling the usage of a device, inaccordance with at least one aspect of the present disclosure, inaccordance with at least one aspect of the present disclosure;

FIG. 134 illustrates a surgical system that includes a handle having acontroller and a motor, an adapter releasably coupled to the handle, anda loading unit releasably coupled to the adapter, in accordance with atleast one aspect of the present disclosure;

FIG. 135 illustrates a verbal Automated Endoscopic System for OptimalPositioning (AESOP) camera positioning system, in accordance with atleast one aspect of the present disclosure;

FIG. 136 illustrates a multi-functional surgical control system andswitching interface for virtual operating room integration, inaccordance with at least one aspect of the present disclosure;

FIG. 137 illustrates a diagram of a beam source and combined beamdetector system utilized as a device control mechanism in an operatingtheater, in accordance with at least one aspect of the presentdisclosure;

FIGS. 138A-E illustrate various types of sterile field control and datainput consoles, in accordance with at least one aspect of the presentdisclosure, where:

FIG. 138A illustrates a single zone sterile field control and data inputconsole;

FIG. 138B illustrates a multi zone sterile field control and data inputconsole;

FIG. 138C illustrates a tethered sterile field control and data inputconsole;

FIG. 138D illustrates a battery operated sterile field control and datainput console; and

FIG. 138E illustrates a battery operated sterile field control and datainput console;

FIGS. 139A-139B illustrate a sterile field console in use in a sterilefield during a surgical procedure, in accordance with at least oneaspect of the present disclosure, where:

FIG. 139A shows the sterile field console positioned in the sterilefield near two surgeons engaged in an operation; and

FIG. 139B shows one of the surgeons tapping the touchscreen of thesterile field console;

FIG. 140 illustrates a process for accepting consult feeds from anotheroperating room, in accordance with at least one aspect of the presentdisclosure;

FIG. 141 illustrates a standard technique for estimating vessel path anddepth and device trajectory, in accordance with at least one aspect ofthe present disclosure;

FIGS. 142A-142D illustrate multiple real time views of images of avirtual anatomical detail for dissection, in accordance with at leastone aspect of the present disclosure, where:

FIG. 142A is a perspective view of the virtual anatomical detail;

FIG. 142B is a side view of the virtual anatomical detail;

FIG. 142C is a perspective view of the virtual anatomical detail; and

FIG. 142D is a side view of the virtual anatomical detail;

FIGS. 143A-143B illustrate a touchscreen display that may be used withinthe sterile field, in accordance with at least one aspect of the presentdisclosure, where:

FIG. 143A illustrates an image of a surgical site displayed on atouchscreen display in portrait mode;

FIG. 143B shows the touchscreen display rotated in landscape mode andthe surgeon uses his index finger to scroll the image in the directionof the arrows;

FIG. 143C shows the surgeon using his index finger and thumb to pinchopen the image in the direction of the arrows to zoom in;

FIG. 143D shows the surgeon using his index finger and thumb to pinchclose the image in the direction of the arrows to zoom out; and

FIG. 143E shows the touchscreen display rotated in two directionsindicated by arrows to enable the surgeon to view the image in differentorientations;

FIG. 144 illustrates a surgical site employing a smart retractorcomprising a direct interface control to a surgical hub, in accordancewith at least one aspect of the present disclosure;

FIG. 145 illustrates a surgical site with a smart flexible stickerdisplay attached to the body of a patient, in accordance with at leastone aspect of the present disclosure;

FIG. 146 is a logic flow diagram of a process depicting a controlprogram or a logic configuration to communicate from inside a sterilefield to a device located outside the sterile field, in accordance withat least one aspect of the present disclosure;

FIG. 147 illustrates a system for performing surgery, in accordance withat least one aspect of the present disclosure;

FIG. 148 illustrates a second layer of information overlaying a firstlayer of information, in accordance with at least one aspect of thepresent disclosure;

FIG. 149 depicts a perspective view of a surgeon using a surgicalinstrument that includes a handle assembly housing and a wirelesscircuit board during a surgical procedure, with the surgeon wearing aset of safety glasses, in accordance with at least one aspect of thepresent disclosure;

FIG. 150 is a schematic diagram of a feedback control system forcontrolling a surgical instrument, in accordance with at least oneaspect of the present disclosure;

FIG. 151 illustrates a feedback controller that includes an on-screendisplay module and a heads up display (HUD) module, in accordance withat least one aspect of the present disclosure;

FIG. 152A illustrates a visualization system that may be incorporatedinto a surgical system, in accordance with at least one aspect of thepresent disclosure;

FIG. 152B illustrates a top plan view of a hand unit of thevisualization system of FIG. 152A, in accordance with at least oneaspect of the present disclosure;

FIG. 152C illustrates a side plan view of the hand unit depicted in FIG.152A along with an imaging sensor disposed therein, in accordance withat least one aspect of the present disclosure;

FIG. 152D illustrates a plurality of an imaging sensors a depicted inFIG. 152C, in accordance with at least one aspect of the presentdisclosure;

FIG. 153A illustrates a plurality of laser emitters that may beincorporated in the visualization system of FIG. 152A, in accordancewith at least one aspect of the present disclosure;

FIG. 153B illustrates illumination of an image sensor having a Bayerpattern of color filters, in accordance with at least one aspect of thepresent disclosure;

FIG. 153C illustrates a graphical representation of the operation of apixel array for a plurality of frames, in accordance with at least oneaspect of the present disclosure;

FIG. 153D illustrates a schematic of an example of an operation sequenceof chrominance and luminance frames, in accordance with at least oneaspect of the present disclosure;

FIG. 153E illustrates an example of sensor and emitter patterns, inaccordance with at least one aspect of the present disclosure;

FIG. 153F illustrates a graphical representation of the operation of apixel array, in accordance with at least one aspect of the presentdisclosure;

FIG. 154 illustrates a schematic of one example of instrumentation forNIR spectroscopy, according to one aspect of the present disclosure;

FIG. 155 illustrates schematically one example of instrumentation fordetermining NIRS based on Fourier transform infrared imaging, inaccordance with at least one aspect of the present disclosure;

FIGS. 156A-C illustrate a change in wavelength of light scattered frommoving blood cells, in accordance with at least one aspect of thepresent disclosure;

FIG. 157 illustrates an aspect of instrumentation that may be used todetect a Doppler shift in laser light scattered from portions of atissue, in accordance with at least one aspect of the presentdisclosure;

FIG. 158 illustrates schematically some optical effects on lightimpinging on a tissue having subsurface structures, in accordance withat least one aspect of the present disclosure;

FIG. 159 illustrates an example of the effects on a Doppler analysis oflight impinging on a tissue sample having subsurface structures, inaccordance with at least one aspect of the present disclosure;

FIGS. 160A-C illustrate schematically the detection of moving bloodcells at a tissue depth based on a laser Doppler analysis at a varietyof laser wavelengths, in accordance with at least one aspect of thepresent disclosure;

FIG. 160D illustrates the effect of illuminating a CMOS imaging sensorwith a plurality of light wavelengths over time, in accordance with atleast one aspect of the present disclosure;

FIG. 161 illustrates an example of a use of Doppler imaging to detectthe present of subsurface blood vessels, in accordance with at least oneaspect of the present disclosure;

FIG. 162 illustrates a method to identify a subsurface blood vesselbased on a Doppler shift of blue light due to blood cells flowingtherethrough, in accordance with at least one aspect of the presentdisclosure;

FIG. 163 illustrates schematically localization of a deep subsurfaceblood vessel, in accordance with at least one aspect of the presentdisclosure;

FIG. 164 illustrates schematically localization of a shallow subsurfaceblood vessel, in accordance with at least one aspect of the presentdisclosure;

FIG. 165 illustrates a composite image comprising a surface image and animage of a subsurface blood vessel, in accordance with at least oneaspect of the present disclosure;

FIG. 166 is a flow chart of a method for determining a depth of asurface feature in a piece of tissue, in accordance with at least oneaspect of the present disclosure;

FIG. 167 illustrates the effect of the location and characteristics ofnon-vascular structures on light impinging on a tissue sample, inaccordance with at least one aspect of the present disclosure;

FIG. 168 schematically depicts one example of components used in a fullfield OCT device, in accordance with at least one aspect of the presentdisclosure;

FIG. 169 illustrates schematically the effect of tissue anomalies onlight reflected from a tissue sample, in accordance with at least oneaspect of the present disclosure;

FIG. 170 illustrates an image display derived from a combination oftissue visualization modalities, in accordance with at least one aspectof the present disclosure;

FIGS. 171A-C illustrate several aspects of displays that may be providedto a surgeon for a visual identification of a combination of surface andsub-surface structures of a tissue in a surgical site, in accordancewith at least one aspect of the present disclosure;

FIG. 172 is a flow chart of a method for providing information relatedto a characteristic of a tissue to a smart surgical instrument, inaccordance with at least one aspect of the present disclosure;

FIGS. 173A and 173B illustrate a multi-pixel light sensor receiving bylight reflected by a tissue illuminated by sequential exposure to red,green, blue, and infrared light, and red, green, blue, and ultravioletlaser light sources, respectively, in accordance with at least oneaspect of the present disclosure;

FIGS. 174A and 174B illustrate the distal end of an elongated cameraprobe having a single light sensor and two light sensors, respectively,in accordance with at least one aspect of the present disclosure;

FIG. 174C illustrates a perspective view of an example of a monolithicsensor having a plurality of pixel arrays, in accordance with at leastone aspect of the present disclosure;

FIG. 175 illustrates one example of a pair of fields of view availableto two image sensors of an elongated camera probe, in accordance with atleast one aspect of the present disclosure;

FIGS. 176A-D illustrate additional examples of a pair of fields of viewavailable to two image sensors of an elongated camera probe, inaccordance with at least one aspect of the present disclosure;

FIGS. 177A-C illustrate an example of the use of an imaging systemincorporating the features disclosed in FIG. 176D, in accordance with atleast one aspect of the present disclosure;

FIGS. 178A and 178B depict another example of the use of a dual imagingsystem, in accordance with at least one aspect of the presentdisclosure;

FIGS. 179A-C illustrate examples of a sequence of surgical steps whichmay benefit from the use of multi-image analysis at the surgical site,in accordance with at least one aspect of the present disclosure;

FIG. 180 is a block diagram of the computer-implemented interactivesurgical system, in accordance with at least one aspect of the presentdisclosure;

FIG. 181 is a block diagram which illustrates the functionalarchitecture of the computer-implemented interactive surgical system, inaccordance with at least one aspect of the present disclosure;

FIG. 182 is an example illustration of a tabulation of various resourcescorrelated to particular types of surgical categories, in accordancewith at least one aspect of the present disclosure;

FIG. 183 provides an example illustration of how data is analyzed by thecloud system to provide a comparison between multiple facilities tocompare use of resources, in accordance with at least one aspect of thepresent disclosure;

FIG. 184 illustrates one example of how the cloud system may determineefficacy trends from an aggregated set of data across whole regions, inaccordance with at least one aspect of the present disclosure;

FIG. 185 provides an example illustration of some types of analysis thecloud system may be configured to perform to provide the predictingmodeling, in accordance with at least one aspect of the presentdisclosure;

FIG. 186 provides a graphical illustration of a type of example analysisthe cloud system may perform to provide these recommendations, inaccordance with at least one aspect of the present disclosure;

FIG. 187 provides an illustration of how the cloud system may conductanalysis to identify a statistical correlation to a local issue that istied to how a device is used in the localized setting, in accordancewith at least one aspect of the present disclosure;

FIG. 188 provides a graphical illustration of an example of how somedevices may satisfy an equivalent use compared to an intended device,and that the cloud system may determine such equivalent use, inaccordance with at least one aspect of the present disclosure;

FIG. 189 provides various examples of how some data may be used asvariables in deciding how a post-operative decision tree may branch out,in accordance with at least one aspect of the present disclosure;

FIG. 190 illustrates a block diagram of a computer-implementedinteractive surgical system that is configured to adaptively generatecontrol program updates for modular devices, in accordance with at leastone aspect of the present disclosure;

FIG. 191 illustrates a logic flow diagram of a process for updating thecontrol program of a modular device, in accordance with at least oneaspect of the present disclosure;

FIG. 192 illustrates a diagram of an illustrative analytics systemupdating a surgical instrument control program, in accordance with atleast one aspect of the present disclosure;

FIG. 193 illustrates a diagram of an analytics system pushing an updateto a modular device through a surgical hub, in accordance with at leastone aspect of the present disclosure;

FIG. 194 illustrates a diagram of a computer-implemented interactivesurgical system that is configured to adaptively generate controlprogram updates for surgical hubs, in accordance with at least oneaspect of the present disclosure;

FIG. 195 illustrates a logic flow diagram of a process for updating thecontrol program of a surgical hub, in accordance with at least oneaspect of the present disclosure;

FIG. 196 illustrates a logic flow diagram of a process for updating thedata analysis algorithm of a control program of a surgical hub, inaccordance with at least one aspect of the present disclosure;

FIG. 197 provides an illustration of example functionality by a cloudmedical analytics system for providing improved security andauthentication to multiple medical facilities that are interconnected,in accordance with at least one aspect of the present disclosure;

FIG. 198 is a flow diagram of the computer-implemented interactivesurgical system programmed to use screening criteria to determinecritical data and to push requests to a surgical hub to obtainadditional data, in accordance with at least one aspect of the presentdisclosure;

FIG. 199 is a flow diagram of an aspect of responding to critical databy the computer-implemented interactive surgical system, in accordancewith at least one aspect of the present disclosure;

FIG. 200 is a flow diagram of an aspect of data sorting andprioritization by the computer-implemented interactive surgical system,in accordance with at least one aspect of the present disclosure;

FIG. 201 illustrates an example system for implementing automatedinventory control, in accordance with at least one aspect of the presentdisclosure;

FIG. 202 illustrates one example of an institution's cloud interfacethrough which a proposed surgical procedure may be entered, inaccordance with at least one aspect of the present disclosure;

FIG. 203 illustrates one example of an institution's cloud interfacethrough which a cloud-based system provides knowledge regarding theavailability and/or usability of inventory items associated with anentered surgical procedure based on system-defined constraints, inaccordance with at least one aspect of the present disclosure;

FIG. 204 illustrates a surgical tool including modular componentswherein the status of each modular component is evaluated based onsystem-defined constraints, in accordance with at least one aspect ofthe present disclosure;

FIG. 205 is a schematic of a robotic surgical system, in accordance withone aspect of the present disclosure;

FIG. 206 is a plan view of a minimally invasivetelesurgically-controlled robotic surgical system being used to performa surgery, in accordance with one aspect of the present disclosure;

FIG. 207 is a perspective view of a surgeon's control console of thesurgical system of FIG. 206, in accordance with one aspect of thepresent disclosure;

FIG. 208 is a perspective view of an electronics cart of the surgicalsystem of FIG. 206, in accordance with one aspect of the presentdisclosure;

FIG. 209 is a diagram of a telesurgically-controlled surgical system, inaccordance with one aspect of the present disclosure;

FIG. 210 is a partial view of a patient side cart of the surgical systemof FIG. 206, in accordance with one aspect of the present disclosure;

FIG. 211 is a front view of a telesurgically-operated surgery tool forthe surgical system of FIG. 206, in accordance with one aspect of thepresent disclosure;

FIG. 212 is a control schematic diagram of a telesurgically-controlledsurgical system, in accordance with one aspect of the presentdisclosure;

FIG. 213 is an elevation view of a robotic surgical system and variouscommunication paths thereof, in accordance with one aspect of thepresent disclosure;

FIG. 214 is a perspective, exploded view of an interface between arobotic tool and a tool mounting portion of the robotic surgical systemof FIG. 213;

FIG. 215 is a detail view of the interface of FIG. 214, in accordancewith one aspect of the present disclosure;

FIG. 216 is a perspective view of a bipolar radio frequency (RF) robotictool having a smoke evacuation pump for use with a robotic surgicalsystem, in accordance with one aspect of the present disclosure;

FIG. 217 is a perspective view of the end effector of the bipolar radiofrequency robotic tool of FIG. 216 depicting the end effector clampingand treating tissue, in accordance with one aspect of the presentdisclosure;

FIG. 218 is a plan view of the tool drive interface of the bipolar radiofrequency robotic tool of FIG. 216 with components removed for clarity,in accordance with one aspect of the present disclosure;

FIG. 219 is a plan view of an ultrasonic robotic tool having cooling andinsufflation features for use with a robotic surgical system, inaccordance with one aspect of the present disclosure;

FIG. 220 is a flow chart of a control algorithm for a robotic tool foruse with a robotic surgical system, in accordance with one aspect of thepresent disclosure;

FIG. 221 is a perspective view of a drive system for a robotic surgicaltool, in accordance with one aspect of the present disclosure;

FIG. 222 is an exploded perspective view of the drive system of FIG.221, in accordance with at least one aspect of the present disclosure;

FIG. 223 is a perspective, partial cross-section view of a proximalhousing of the robotic surgical tool of FIG. 221, depicting atransmission arrangement within the proximal housing, in accordance withat least one aspect of the present disclosure;

FIG. 224 is an exploded perspective view of the transmission arrangementof FIG. 223, in accordance with one aspect of the present disclosure;

FIG. 225 is an exploded perspective view of the transmission arrangementof FIG. 223 with various parts removed for clarity, depicting thetransmission arrangement in a first configuration in which a firstcooperative drive is drivingly coupled to a first output shaft and asecond cooperative drive is drivingly coupled to a second output shaft,in accordance with one aspect of the present disclosure;

FIG. 226 is an exploded perspective view of the transmission arrangementof FIG. 223 with various parts removed for clarity, depicting thetransmission arrangement in a second configuration in which the firstcooperative drive and the second cooperative drive are drivingly coupledto a third output shaft, in accordance with one aspect of the presentdisclosure;

FIG. 227 is an exploded perspective view of the transmission arrangementof FIG. 223 with various parts removed for clarity, depicting thetransmission arrangement in a third configuration in which the firstcooperative drive and the second cooperative drive are drivingly coupledto a fourth output shaft, in accordance with one aspect of the presentdisclosure;

FIG. 228 is an exploded, cross-section elevation view of thetransmission arrangement of FIG. 223, in accordance with at least oneaspect of the present disclosure;

FIG. 229 is a graphical display of output torque for different surgicalfunctions of the robotic surgical tool of FIG. 221, in accordance withat least one aspect of the present disclosure;

FIG. 230 is a perspective view of the robotic surgical tool of FIG. 221in an unactuated configuration, in accordance with one aspect of thepresent disclosure;

FIG. 231 is a perspective view of the robotic surgical tool of FIG. 221in an articulated configuration, in accordance with one aspect of thepresent disclosure;

FIG. 232 is a perspective view of the robotic surgical tool of FIG. 221in a rotated configuration, in accordance with one aspect of the presentdisclosure;

FIG. 233 is a perspective view of the robotic surgical tool of FIG. 221in a clamped and fired configuration, in accordance with one aspect ofthe present disclosure;

FIG. 234 is a view of robotically-controlled end effectors at a surgicalsite, in accordance with one aspect of the present disclosure;

FIG. 235 is a view of the robotically-controlled end effectors of FIG.234, in accordance with one aspect of the present disclosure;

FIG. 236 is a graphical display of force and displacement over time forone of the robotically-controlled end effectors of FIG. 234, inaccordance with one aspect of the present disclosure;

FIG. 237 is a flow chart of a control algorithm for one a surgical toolfor use with a robotic surgical system, in accordance with one aspect ofthe present disclosure;

FIG. 238 is an elevation view of a surgical procedure involving arobotic surgical system and a handheld surgical instrument and depictingmultiple displays in the surgical theater, in accordance with one aspectof the present disclosure;

FIG. 239 is a schematic of a robotic surgical system, in accordance withat least one aspect of the present disclosure;

FIG. 240 is a block diagram of control components for the roboticsurgical system of FIG. 239, in accordance with at least one aspect ofthe present disclosure;

FIG. 241A is an elevation view of an ultrasonic surgical tool positionedout of contact with tissue, in accordance with at least one aspect ofthe present disclosure;

FIG. 241B is an elevation view of the ultrasonic surgical tool of FIG.241A positioned in abutting contact with tissue, in accordance with atleast one aspect of the present disclosure;

FIG. 242A is an elevation view of a monopolar cautery pencil positionedout of contact with tissue, in accordance with at least one aspect ofthe present disclosure;

FIG. 242B is an elevation view of the monopolar cautery pencil of FIG.242A positioned in abutting contact with tissue, in accordance with atleast one aspect of the present disclosure;

FIG. 243 is a graphical display of continuity and current over time forthe ultrasonic surgical tool of FIGS. 241A and 241B, in accordance withat least one aspect of the present disclosure;

FIG. 244 illustrates an end effector comprising radio frequency (RF)data sensors located on a jaw member, in accordance with at least oneaspect of the present disclosure;

FIG. 245 illustrates the sensors shown in FIG. 244 mounted to or formedintegrally with a flexible circuit, in accordance with at least oneaspect of the present disclosure;

FIG. 246 is a flow chart depicting an automatic activation mode of asurgical instrument, in accordance with at least one aspect of thepresent disclosure;

FIG. 247 is a perspective view of an end effector of a bipolar radiofrequency (RF) surgical tool having a smoke evacuation pump for use witha robotic surgical system, depicting the surgical tool clamping andtreating tissue, in accordance with at least one aspect of the presentdisclosure;

FIG. 248 is a block diagram of a surgical system comprising a roboticsurgical system, a handheld surgical instrument, and a surgical hub, inaccordance with at least one aspect of the present disclosure;

FIG. 249 is a perspective view of a handle portion of a handheldsurgical instrument including a display and further depicting a detailview of the display depicting information from the instrument itself, inaccordance with at least one aspect of the present disclosure;

FIG. 250 is a perspective view of the handle portion of the handheldsurgical instrument of FIG. 249 depicting the instrument paired with asurgical hub and further including a detail view of the displaydepicting information from the surgical hub, in accordance with at leastone aspect of the present disclosure;

FIG. 251 is a schematic of a colon resection procedure, in accordancewith at least one aspect of the present disclosure;

FIG. 252 is a graphical display of force over time for the colonresection procedure displayed on the instrument display in FIG. 251, inaccordance with at least one aspect of the present disclosure;

FIG. 253 is a schematic of a robotic surgical system during a surgicalprocedure including a plurality of hubs and interactive secondarydisplays, in accordance with at least one aspect of the presentdisclosure;

FIG. 254 is a detail view of the interactive secondary displays of FIG.253, in accordance with at least one aspect of the present disclosure;

FIG. 255 is a block diagram of a robotic surgical system comprising morethan one robotic arm, in accordance with at least one aspect of thepresent disclosure;

FIG. 256 is a schematic of a surgical procedure utilizing the roboticsurgical system of FIG. 255, in accordance with at least one aspect ofthe present disclosure;

FIG. 257 shows graphical representations of forces and positionaldisplacements experienced by the robotic arms of FIG. 255, in accordancewith at least one aspect of the present disclosure;

FIG. 258 is a flow chart depicting an algorithm for controlling theposition of the robotic arms of a robotic surgical system, in accordancewith at least one aspect of the present disclosure;

FIG. 259 is a flow chart depicting an algorithm for controlling theforces exerted by robotic arms of a robotic surgical system, inaccordance with at least one aspect of the present disclosure;

FIG. 260 is a flow chart depicting an algorithm for monitoring theposition and forces exerted by robotic arms of a robotic surgicalsystem, in accordance with at least one aspect of the presentdisclosure;

FIG. 261 is a block diagram of a surgical system comprising a roboticsurgical system, a powered handheld surgical instrument, and a surgicalhub, in accordance with at least one aspect of the present disclosure;

FIG. 262 is a perspective view of a robotic tool and a handheld surgicalinstrument during a surgical procedure, in accordance with at least oneaspect of the present disclosure;

FIG. 263 is a schematic depicting communication links between surgicalhubs and a primary server, in accordance with at least one aspect of thepresent disclosure;

FIG. 264 is a flow chart depicting a queue for external output of datareceived from the various surgical hubs of FIG. 263, in accordance withat least one aspect of the present disclosure;

FIG. 265 is a perspective view of a robot arm of a robotic surgicalsystem and schematically depicts additional components of the roboticsurgical system, in accordance with one aspect of the presentdisclosure;

FIG. 266 is a perspective view of a robotic arm of a robotic surgicalsystem, and further depicts an operator manually adjusting the positionof the robotic arm, in accordance with one aspect of the presentdisclosure;

FIG. 267 is a graphical display of force over time of the robotic arm ofFIG. 266 in a passive power assist mode, in accordance with one aspectof the present disclosure;

FIG. 268 is a perspective view of a robotic arm and a secondaryinteractive display within a sterile field, in accordance with at leastone aspect of the present disclosure.

FIG. 269 is a graphical display of force over time of the robotic arm ofFIG. 268, in accordance with one aspect of the present disclosure;

FIG. 270 is a perspective view of a robotic arm and a robotic hub of arobotic surgical system, in accordance with at least one aspect of thepresent disclosure;

FIG. 271 is a detail view of an end effector of a linear staplerattached to the robotic arm of FIG. 270, depicting the end effectorpositioned relative to a targeted tissue region during a surgicalprocedure, in accordance with at least one aspect of the presentdisclosure;

FIG. 272 is a graphical display of distance and force-to-close over timefor the linear stapler of FIG. 271, in accordance with one aspect of thepresent disclosure;

FIG. 273 is a schematic depicting a robotic surgical system having aplurality of sensing systems, in accordance with one aspect of thepresent disclosure;

FIG. 273A is a detail view of a trocar of FIG. 273, in accordance withat least one aspect of the present disclosure;

FIG. 274 is a flowchart depicting a robotic surgical system utilizing aplurality of independent sensing systems, in accordance with one aspectof the present disclosure;

FIG. 275 is a partial perspective view of a clip applier;

FIG. 276 is a cross-sectional view of an end effector of the clipapplier of FIG. 275 comprising a removable clip cartridge, areciprocating firing drive for sequentially advancing the clips, areceiver for receiving the clips, and a crimping drive for deforming theclips;

FIG. 277 is a partial cross-sectional view of the clip applier of FIG.275 in an open configuration;

FIG. 278 is a partial cross-sectional view of the clip applier of FIG.275 in a closed configuration;

FIG. 279 is a cross-sectional view of the end effector of FIG. 276 in anunfired condition;

FIG. 280 is a cross-sectional view of the end effector of FIG. 276illustrating the firing drive in a partially fired condition in which afiring member of the firing drive has advanced a clip into the receiver;

FIG. 281 is a cross-sectional view of the end effector of FIG. 276illustrating the firing drive coming into engagement with the crimpingdrive;

FIG. 282 is a cross-sectional view of the end effector of FIG. 276illustrating the crimping drive in an at least partially firedcondition;

FIG. 283 is a cross-sectional view of the end effector of FIG. 276illustrating the firing drive becoming disengaged from the firingmember;

FIG. 284 is a cross-sectional view of the end effector of FIG. 276illustrating the crimping drive in its fully fired condition;

FIG. 285 is a cross-sectional view of the firing drive of the endeffector of FIG. 276 in a partially retracted position in which thefiring drive is being re-engaged with the firing member;

FIG. 286 is a cross-sectional view of the firing drive of the endeffector of FIG. 276 being disengaged from the crimping drive;

FIG. 287 is a perspective view of a clip illustrated in FIGS. 276-286;

FIG. 288 is a front view of a cartridge illustrated in FIGS. 275-286comprising a plurality of clips with portions of the cartridge removedto illustrate the clips stored in the cartridge;

FIG. 289 is a side view of the cartridge of FIG. 288 illustrated withportions removed to illustrate the clips stored in the cartridge;

FIG. 290 is a cross-sectional plan view of the cartridge of FIG. 288taken along line 290-290 in FIG. 289;

FIG. 291 is a side view of an alternative cartridge usable in connectionwith the clip applier of FIGS. 275-286 or any other suitable clipapplier, wherein the cartridge is illustrated with portions removed toillustrate a biasing member and a pusher plate positioned intermediatethe biasing member and the clips contained therein;

FIG. 292 is a side view of a cartridge in accordance with at least onealternative embodiment illustrated with portions removed to illustrate abiasing member and a lockout plate positioned intermediate the biasingmember and the clips contained therein;

FIG. 293 is a cross-sectional plan view of the cartridge of FIG. 292taken along line 293-293 in FIG. 292;

FIG. 294 is a side view of a further alternative cartridge usable inconnection with the clip applier of FIGS. 275-286 or any other suitableclip applier, wherein the cartridge can comprise a housing illustratedwith portions removed to illustrate a lockout plate comprising guideswhich are configured to co-operate with guides defined in the cartridgehousing;

FIG. 295 is a cross-sectional plan view of the cartridge of FIG. 294taken along line 295-295 in FIG. 294;

FIG. 296 is an elevational view of a firing drive comprising a rotaryinput, a rotary output, a firing nut engaged with the rotary output, anda transmission in a firing configuration in accordance with at least oneembodiment;

FIG. 297 is a perspective view of the firing drive of FIG. 296illustrating the firing nut in an unfired position;

FIG. 298 is a perspective view of the firing drive of FIG. 296illustrating the firing nut advanced along the rotary output and a camextending from the firing nut;

FIG. 299 is a perspective view of the firing drive of FIG. 296illustrating the cam of the firing nut engaged with the transmission ofthe firing drive and the transmission in a reverse configuration;

FIG. 300 is a perspective view of the firing drive of FIG. 296illustrating firing nut in a retracted position and a second camextending from the firing nut engaged with the transmission to shift thetransmission from its reverse configuration to its firing configuration;

FIG. 301 is a perspective view of a robotic surgical instrument systemoperably supporting a plurality of surgical tools usable with the clipapplier of FIGS. 276-286 or any other suitable clip applier;

FIG. 302 is a perspective view of a surgical tool including an actuatormodule, a shaft extending from the actuator module, and a replaceableend effector;

FIG. 303 is a perspective view of a handle actuator usable with the clipapplier of FIGS. 276-286 or any other suitable clip applier;

FIG. 304 is a cross-sectional view of the articulation joint illustratedin FIG. 276;

FIG. 305 is a rear perspective view of an alternative actuator modulethat may be used in place of the actuator module of FIG. 302 with atleast a portion of its housing removed;

FIG. 306 is an exploded view of a portion of the actuator module of FIG.305;

FIG. 307 is a partial sectional view of the actuator module of FIG. 305;

FIG. 308 is a cross-sectional view of an articulation actuator of theactuator module of FIG. 305;

FIG. 309 is a partial cross-sectional view of an end effector of a clipapplier in a closed configuration;

FIG. 310 is a partial cross-sectional view of the end effector of FIG.309 in an open configuration;

FIG. 311 is a cross-sectional view of the end effector of FIG. 309 in anopen configuration;

FIG. 312 is a partial cross-sectional view of the end effector of FIG.309 illustrating the position of a stored clip when a crimping drive ofthe end effector is in a fully fired position;

FIG. 313 is a partial cross-sectional view of the end effector of FIG.309 illustrating the position of the stored clip when the crimping driveis in a home position;

FIG. 314 is a partial cross-sectional view of the end effector of FIG.309 illustrating the position of the stored clip when the crimping driveis in a fully retracted position;

FIG. 315 is a partial cross-sectional view of a clip applier comprisinga clip cartridge containing clips having a first size;

FIG. 316 is a partial cross-sectional view of the clip applier of FIG.315 comprising a different clip cartridge containing clips having asecond size;

FIG. 317 is a partial cross-sectional view of a multi-level clip stackarrangement;

FIG. 318 is a perspective view of a clip applier comprising anattachment mechanism;

FIG. 319 is a cross-sectional view of the clip applier of FIG. 319;

FIG. 320 is a perspective view of a clip applier comprising a clipmagazine;

FIG. 321 is a perspective view of clips for use with the clip applier ofFIG. 320;

FIG. 322 is a perspective view of a clip reloader for use with a clipapplier comprising a clip magazine;

FIG. 323 is a perspective view of a clip reloader;

FIG. 324 is a cross-sectional view of the clip reloader of FIG. 323;

FIG. 325 is a cross-sectional view of the clip reloader of FIG. 323 andan end effector of a clip applier;

FIG. 326 is a partial cross-sectional plan view of a clip applier;

FIG. 327 is a partial cross-sectional side view of the clip applier ofFIG. 326;

FIG. 328 is a perspective view of the clip applier of FIG. 326;

FIG. 329 is a perspective view of a clip including a flexible base;

FIG. 330 is a side view of the clip of FIG. 329 in variousconfigurations;

FIG. 331 is a perspective view of a clip for use with a clip applier;

FIG. 332 is a side view of the clip of FIG. 331 in a storageconfiguration;

FIG. 333 is a side view of the clip of FIG. 331 in a pre-firingconfiguration;

FIG. 334 is a side view of the clip of FIG. 331 in a post-firingconfiguration;

FIG. 335 is a perspective view of a clip applier including a rotatableclip magazine;

FIG. 336 is a partial cross-sectional view of the clip applier of FIG.335 illustrating a closure tube of the clip applier in a fully retractedposition;

FIG. 337 is a partial cross-sectional view of the clip applier of FIG.335 illustrating the closure tube in a home position;

FIG. 338 is a perspective view of a ground portion including a clockingportion of the clip applier of FIG. 335;

FIG. 339 is a partial cross-sectional view of the clip applier of FIG.335 illustrating clips stored in the rotatable clip magazine prior tobeing advanced, illustrated with some components removed;

FIG. 340 is a partial cross-sectional view of the clip applier of FIG.335 illustrating a clip being advanced from the rotatable clip magazineby a feeder member of the clip applier;

FIG. 341 is a partial cross-sectional view of the clip applier of FIG.335 illustrating the feeder member retracted;

FIG. 342 is a partial cross-sectional view of the clip applier for FIG.335 illustrating a closure tube of the clip applier in a fully retractedposition;

FIG. 343 is a partial cross-sectional view of the clip applier of FIG.335 illustrating the closure tube in a home position and a firing memberadvancing a clip, illustrated with some components removed;

FIG. 344 is a partial cross-sectional view of the clip applier of FIG.336 illustrating the firing member retracted and the closure tube in afully advanced position, illustrated with some components removed;

FIG. 345 is a partial cross-sectional view of a clip applier comprisinga replaceable cartridge;

FIG. 346 is a cross-sectional end view of a rotatable clip magazine;

FIG. 347 is a plan view of a clip for use with the rotatable clipmagazine of FIG. 346;

FIG. 348 is a perspective view of a releasable clip cartridge includingan articulation joint;

FIG. 349 is a partial cross-sectional view of the releasable clipcartridge and articulation joint of FIG. 348;

FIG. 350 is a perspective view of a clip applier including anarticulation joint;

FIG. 351 is a partial cross-sectional view of a clip applier jawassembly;

FIG. 352 is a partial cross-sectional view of clip applier jaw assemblyincluding offset support legs;

FIG. 353 is a partial cross-sectional view of the clip applier jawassembly of FIG. 352;

FIG. 354 is a partial cross sectional plan view of the clip applier jawassembly of FIG. 351;

FIG. 355 is a partial cross sectional plan view of the clip applier jawassembly of FIG. 352;

FIG. 356 is a graphical depiction of the movements of a cam member and afeeder shoe of a clip applier throughout the operation of the clipapplier;

FIG. 357 is a graph depicting the displacement of a cam member andfeeder shoe of the clip applier of FIG. 335 as a function of time;

FIG. 358 depicts a first graph illustrating the force to advance a clipof a clip applier as a function of displacement and a second graphillustrating the voltage of a motor of the clip applier as a function oftime;

FIG. 359 depicts a graph of the force applied to a pair of jaws of aclip applier versus time;

FIG. 360 is directed to an alternative embodiment;

FIG. 361 is directed to an alternative embodiment;

FIG. 362 is a perspective view of a clip applier including a rotatingclip magazine, a magnet, and a Hall Effect sensor;

FIG. 363 is a graphical depiction of the clip applier of FIG. 362illustrating the voltage of the Hall Effect sensor as a function of theposition of the magnet over time;

FIG. 364 is a partial cross-sectional view of a clip applier includingresistive sensing circuits;

FIG. 365 is a partial cross-sectional view of a clip applier including avariable resistance meter;

FIG. 366 is a partial cross-sectional view of the clip applier of FIG.365 in a partially crimped configuration;

FIG. 367 is a perspective view of a clip applier jaw including straingauges;

FIG. 368 is a graphical depiction of the clip applier jaw of FIG. 367illustrating the voltage of the strain gauges as a function of time;

FIG. 369 is a partial cross-sectional view of a clip applier including asensor array and a magnet;

FIG. 370 is a partial cross-sectional view of the clip applier of FIG.369;

FIG. 371 is a perspective view of a clip applier system utilizing atrocar;

FIG. 372 is a perspective view of the clip applier system of FIG. 371;

FIG. 373 is a partial side elevation view of the clip applier system ofFIG. 371 depicting a jaw wing of a clip applier of the clip appliersystem positioned distal to a loading arm of a clip magazine of the clipapplier system;

FIG. 374 is a partial side elevation view of the clip applier system ofFIG. 371 depicting the jaw wing of the clip applier positioned proximalto the loading arm of the clip magazine;

FIG. 375 is a partial side elevation view of the clip applier system ofFIG. 371 depicting the jaw wing of the clip applier positioned proximalto the loading arm of the clip magazine;

FIG. 376 is a partial perspective view of the clip applier system ofFIG. 371;

FIG. 377 is a cross-sectional perspective view of the clip appliersystem of FIG. 371;

FIG. 378 is a plan view of the clip applier system of FIG. 371 depictinga jaw wing of the clip applier in an expanded configuration;

FIG. 379 is a plan view of the clip applier system of FIG. 371 depictingthe jaw wing of the clip applier in a retracted configuration;

FIG. 380 is a perspective view of a clip applier and a clip magazine foruse with the clip applier;

FIG. 381 is a perspective view of the clip magazine seated into the clipapplier of FIG. 380;

FIG. 382 is a perspective view of the clip applier and the clip magazineof FIG. 380 in a loaded configuration;

FIG. 383 is a cross-sectional view of the clip applier and the clipmagazine of FIG. 380 in the loaded configuration of FIG. 382;

FIG. 384 is a perspective view the spent clip magazine removed from theclip applier of FIG. 380;

FIG. 385 is a plan view of the spent clip magazine seated into the clipapplier of FIG. 380;

FIG. 386 is a cross-sectional plan view of the clip applier and the clipmagazine of FIG. 380;

FIG. 387 is a cross-sectional plan view of the clip applier and the clipmagazine of FIG. 380 in a nearly spent configuration; and

FIG. 388 is a schematic of a control system for use with any of thesurgical instruments disclosed herein.

Corresponding reference characters indicate corresponding partsthroughout the several views. The exemplifications set out hereinillustrate various embodiments of the invention, in one form, and suchexemplifications are not to be construed as limiting the scope of theinvention in any manner.

DETAILED DESCRIPTION

Applicant of the present application owns the following U.S. patentapplications that were filed on Aug. 24, 2018 which are each hereinincorporated by reference in their respective entireties:

U.S. patent application Ser. No. 16/112,129, entitled SURGICAL SUTURINGINSTRUMENT CONFIGURED TO MANIPULATE TISSUE USING MECHANICAL ANDELECTRICAL POWER; Attorney Docket No. END8567USNP1/180100-1;

U.S. patent application Ser. No. 16/112,155, entitled SURGICAL SUTURINGINSTRUMENT COMPRISING A CAPTURE WIDTH WHICH IS LARGER THAN TROCARDIAMETER; Attorney Docket No. END8567USNP2/180100-2;

U.S. patent application Ser. No. 16/112,168, entitled SURGICAL SUTURINGINSTRUMENT COMPRISING A NON-CIRCULAR NEEDLE; Attorney Docket No.END8567USNP3/180100-3;

U.S. patent application Ser. No. 16/112,180, entitled ELECTRICAL POWEROUTPUT CONTROL BASED ON MECHANICAL FORCES; Attorney Docket No.END8567USNP4/180100-4;

U.S. patent application Ser. No. 16/112,193, entitled REACTIVE ALGORITHMFOR SURGICAL SYSTEM; Attorney Docket No. END8567USNP5/180100-5;

U.S. patent application Ser. No. 16/112,099, entitled SURGICALINSTRUMENT COMPRISING AN ADAPTIVE ELECTRICAL SYSTEM; Attorney Docket No.END8568USNP1/180101-1;

U.S. patent application Ser. No. 16/112,112, entitled CONTROL SYSTEMARRANGEMENTS FOR A MODULAR SURGICAL INSTRUMENT; Attorney Docket No.END8568USNP2/180101-2;

U.S. patent application Ser. No. 16/112,119, entitled ADAPTIVE CONTROLPROGRAMS FOR A SURGICAL SYSTEM COMPRISING MORE THAN ONE TYPE OFCARTRIDGE; Attorney Docket No. END8568USNP3/180101-3;

U.S. patent application Ser. No. 16/112,097, entitled SURGICALINSTRUMENT SYSTEMS COMPRISING BATTERY ARRANGEMENTS; Attorney Docket No.END8569USNP1/180102-1;

U.S. patent application Ser. No. 16/112,109, entitled SURGICALINSTRUMENT SYSTEMS COMPRISING HANDLE ARRANGEMENTS; Attorney Docket No.END8569USNP2/180102-2;

U.S. patent application Ser. No. 16/112,114, entitled SURGICALINSTRUMENT SYSTEMS COMPRISING FEEDBACK MECHANISMS; Attorney Docket No.END8569USNP3/180102-3;

U.S. patent application Ser. No. 16/112,117, entitled SURGICALINSTRUMENT SYSTEMS COMPRISING LOCKOUT MECHANISMS; Attorney Docket No.END8569USNP4/180102-4;

U.S. patent application Ser. No. 16/112,095, entitled SURGICALINSTRUMENTS COMPRISING A LOCKABLE END EFFECTOR SOCKET; Attorney DocketNo. END8570USNP1/180103-1;

U.S. patent application Ser. No. 16/112,121, entitled SURGICALINSTRUMENTS COMPRISING A SHIFTING MECHANISM; Attorney Docket No.END8570USNP2/180103-2;

U.S. patent application Ser. No. 16/112,151, entitled SURGICALINSTRUMENTS COMPRISING A SYSTEM FOR ARTICULATION AND ROTATIONCOMPENSATION; Attorney Docket No. END8570USNP3/180103-3;

U.S. patent application Ser. No. 16/112,154, entitled SURGICALINSTRUMENTS COMPRISING A BIASED SHIFTING MECHANISM; Attorney Docket No.END8570USNP4/180103-4;

U.S. patent application Ser. No. 16/112,226, entitled SURGICALINSTRUMENTS COMPRISING AN ARTICULATION DRIVE THAT PROVIDES FOR HIGHARTICULATION ANGLES; Attorney Docket No. END8570USNP5/180103-5;

U.S. patent application Ser. No. 16/112,062, entitled SURGICALDISSECTORS AND MANUFACTURING TECHNIQUES; Attorney Docket No.END8571USNP1/180104-1;

U.S. patent application Ser. No. 16/112,098, entitled SURGICALDISSECTORS CONFIGURED TO APPLY MECHANICAL AND ELECTRICAL ENERGY;Attorney Docket No. END8571USNP2/180104-2;

U.S. patent application Ser. No. 16/112,237, entitled SURGICAL CLIPAPPLIER CONFIGURED TO STORE CLIPS IN A STORED STATE; Attorney Docket No.END8572USNP1/180105-1;

U.S. patent application Ser. No. 16/112,245, entitled SURGICAL CLIPAPPLIER COMPRISING AN EMPTY CLIP CARTRIDGE LOCKOUT; Attorney Docket No.END8572USNP2/180105-2;

U.S. patent application Ser. No. 16/112,249, entitled SURGICAL CLIPAPPLIER COMPRISING AN AUTOMATIC CLIP FEEDING SYSTEM; Attorney Docket No.END8572USNP3/180105-3;

U.S. patent application Ser. No. 16/112,253, entitled SURGICAL CLIPAPPLIER COMPRISING ADAPTIVE FIRING CONTROL; Attorney Docket No.END8572USNP4/180105-4; and

U.S. patent application Ser. No. 16/112,257, entitled SURGICAL CLIPAPPLIER COMPRISING ADAPTIVE CONTROL IN RESPONSE TO A STRAIN GAUGECIRCUIT; Attorney Docket No. END8572USNP5/180105-5.

Applicant of the present application owns the following U.S. patentapplications that were filed on May 1, 2018 and which are each hereinincorporated by reference in their respective entireties:

U.S. Patent Application Ser. No. 62/665,129, entitled SURGICAL SUTURINGSYSTEMS;

U.S. Provisional Patent Application Ser. No. 62/665,139, entitledSURGICAL INSTRUMENTS COMPRISING CONTROL SYSTEMS;

U.S. Patent Application Ser. No. 62/665,177, entitled SURGICALINSTRUMENTS COMPRISING HANDLE ARRANGEMENTS;

U.S. Patent Application Ser. No. 62/665,128, entitled MODULAR SURGICALINSTRUMENTS;

U.S. Patent Application Ser. No. 62/665,192, entitled SURGICALDISSECTORS; and

U.S. Patent Application Ser. No. 62/665,134, entitled SURGICAL CLIPAPPLIER.

Applicant of the present application owns the following U.S. patentapplications that were filed on Feb. 28, 2018 and which are each hereinincorporated by reference in their respective entireties:

U.S. patent application Ser. No. 15/908,021, entitled SURGICALINSTRUMENT WITH REMOTE RELEASE;

U.S. patent application Ser. No. 15/908,012, entitled SURGICALINSTRUMENT HAVING DUAL ROTATABLE MEMBERS TO EFFECT DIFFERENT TYPES OFEND EFFECTOR MOVEMENT;

U.S. patent application Ser. No. 15/908,040, entitled SURGICALINSTRUMENT WITH ROTARY DRIVE SELECTIVELY ACTUATING MULTIPLE END EFFECTORFUNCTIONS;

U.S. patent application Ser. No. 15/908,057, entitled SURGICALINSTRUMENT WITH ROTARY DRIVE SELECTIVELY ACTUATING MULTIPLE END EFFECTORFUNCTIONS;

U.S. patent application Ser. No. 15/908,058, entitled SURGICALINSTRUMENT WITH MODULAR POWER SOURCES; and

U.S. patent application Ser. No. 15/908,143, entitled SURGICALINSTRUMENT WITH SENSOR AND/OR CONTROL SYSTEMS.

Applicant of the present application owns the following U.S. patentapplications that were filed on Oct. 30, 2017 and which are each hereinincorporated by reference in their respective entireties:

U.S. Provisional Patent Application Ser. No. 62/578,793, entitledSURGICAL INSTRUMENT WITH REMOTE RELEASE;

U.S. Provisional Patent Application Ser. No. 62/578,804, entitledSURGICAL INSTRUMENT HAVING DUAL ROTATABLE MEMBERS TO EFFECT DIFFERENTTYPES OF END EFFECTOR MOVEMENT;

U.S. Provisional Patent Application Ser. No. 62/578,817, entitledSURGICAL INSTRUMENT WITH ROTARY DRIVE SELECTIVELY ACTUATING MULTIPLE ENDEFFECTOR FUNCTIONS;

U.S. Provisional Patent Application Ser. No. 62/578,835, entitledSURGICAL INSTRUMENT WITH ROTARY DRIVE SELECTIVELY ACTUATING MULTIPLE ENDEFFECTOR FUNCTIONS;

U.S. Provisional Patent Application Ser. No. 62/578,844, entitledSURGICAL INSTRUMENT WITH MODULAR POWER SOURCES; and

U.S. Provisional Patent Application Ser. No. 62/578,855, entitledSURGICAL INSTRUMENT WITH SENSOR AND/OR CONTROL SYSTEMS.

Applicant of the present application owns the following U.S. Provisionalpatent applications, filed on Dec. 28, 2017, the disclosure of each ofwhich is herein incorporated by reference in its entirety:

U.S. Provisional Patent Application Ser. No. 62/611,341, entitledINTERACTIVE SURGICAL PLATFORM;

U.S. Provisional Patent Application Ser. No. 62/611,340, entitledCLOUD-BASED MEDICAL ANALYTICS; and

U.S. Provisional Patent Application Ser. No. 62/611,339, entitled ROBOTASSISTED SURGICAL PLATFORM.

Applicant of the present application owns the following U.S. Provisionalpatent applications, filed on Mar. 28, 2018, each of which is hereinincorporated by reference in its entirety:

U.S. Provisional Patent Application Ser. No. 62/649,302, entitledINTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES;

U.S. Provisional Patent Application Ser. No. 62/649,294, entitled DATASTRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND CREATE ANONYMIZEDRECORD;

U.S. Provisional Patent Application Ser. No. 62/649,300, entitledSURGICAL HUB SITUATIONAL AWARENESS;

U.S. Provisional Patent Application Ser. No. 62/649,309, entitledSURGICAL HUB SPATIAL AWARENESS TO DETERMINE DEVICES IN OPERATINGTHEATER;

U.S. Provisional Patent Application Ser. No. 62/649,310, entitledCOMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS;

U.S. Provisional Patent Application Ser. No. 62/649,291, entitled USE OFLASER LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE PROPERTIES OFBACK SCATTERED LIGHT;

U.S. Provisional Patent Application Ser. No. 62/649,296, entitledADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES;

U.S. Provisional Patent Application Ser. No. 62/649,333, entitledCLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION AND RECOMMENDATIONS TO AUSER;

U.S. Provisional Patent Application Ser. No. 62/649,327, entitledCLOUD-BASED MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS ANDREACTIVE MEASURES;

U.S. Provisional Patent Application Ser. No. 62/649,315, entitled DATAHANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK;

U.S. Provisional Patent Application Ser. No. 62/649,313, entitled CLOUDINTERFACE FOR COUPLED SURGICAL DEVICES;

U.S. Provisional Patent Application Ser. No. 62/649,320, entitled DRIVEARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS;

U.S. Provisional Patent Application Ser. No. 62/649,307, entitledAUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS; and

U.S. Provisional Patent Application Ser. No. 62/649,323, entitledSENSING ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS.

Applicant of the present application owns the following U.S. patentapplications, filed on Mar. 29, 2018, each of which is hereinincorporated by reference in its entirety:

U.S. patent application Ser. No. 15/940,641, entitled INTERACTIVESURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES;

U.S. patent application Ser. No. 15/940,648, entitled INTERACTIVESURGICAL SYSTEMS WITH CONDITION HANDLING OF DEVICES AND DATACAPABILITIES;

U.S. patent application Ser. No. 15/940,656, entitled SURGICAL HUBCOORDINATION OF CONTROL AND COMMUNICATION OF OPERATING ROOM DEVICES;

U.S. patent application Ser. No. 15/940,666, entitled SPATIAL AWARENESSOF SURGICAL HUBS IN OPERATING ROOMS;

U.S. patent application Ser. No. 15/940,670, entitled COOPERATIVEUTILIZATION OF DATA DERIVED FROM SECONDARY SOURCES BY INTELLIGENTSURGICAL HUBS;

U.S. patent application Ser. No. 15/940,677, entitled SURGICAL HUBCONTROL ARRANGEMENTS;

U.S. patent application Ser. No. 15/940,632, entitled DATA STRIPPINGMETHOD TO INTERROGATE PATIENT RECORDS AND CREATE ANONYMIZED RECORD;

U.S. patent application Ser. No. 15/940,640, entitled COMMUNICATION HUBAND STORAGE DEVICE FOR STORING PARAMETERS AND STATUS OF A SURGICALDEVICE TO BE SHARED WITH CLOUD BASED ANALYTICS SYSTEMS;

U.S. patent application Ser. No. 15/940,645, entitled SELF DESCRIBINGDATA PACKETS GENERATED AT AN ISSUING INSTRUMENT;

U.S. patent application Ser. No. 15/940,649, entitled DATA PAIRING TOINTERCONNECT A DEVICE MEASURED PARAMETER WITH AN OUTCOME;

U.S. patent application Ser. No. 15/940,654, entitled SURGICAL HUBSITUATIONAL AWARENESS;

U.S. patent application Ser. No. 15/940,663, entitled SURGICAL SYSTEMDISTRIBUTED PROCESSING;

U.S. patent application Ser. No. 15/940,668, entitled AGGREGATION ANDREPORTING OF SURGICAL HUB DATA;

U.S. patent application Ser. No. 15/940,671, entitled SURGICAL HUBSPATIAL AWARENESS TO DETERMINE DEVICES IN OPERATING THEATER;

U.S. patent application Ser. No. 15/940,686, entitled DISPLAY OFALIGNMENT OF STAPLE CARTRIDGE TO PRIOR LINEAR STAPLE LINE;

U.S. patent application Ser. No. 15/940,700, entitled STERILE FIELDINTERACTIVE CONTROL DISPLAYS;

U.S. patent application Ser. No. 15/940,629, entitled COMPUTERIMPLEMENTED INTERACTIVE SURGICAL SYSTEMS;

U.S. patent application Ser. No. 15/940,704, entitled USE OF LASER LIGHTAND RED-GREEN-BLUE COLORATION TO DETERMINE PROPERTIES OF BACK SCATTEREDLIGHT;

U.S. patent application Ser. No. 15/940,722, entitled CHARACTERIZATIONOF TISSUE IRREGULARITIES THROUGH THE USE OF MONO-CHROMATIC LIGHTREFRACTIVITY; and

U.S. patent application Ser. No. 15/940,742, entitled DUAL CMOS ARRAYIMAGING.

Applicant of the present application owns the following U.S. patentapplications, filed on Mar. 29, 2018, each of which is hereinincorporated by reference in its entirety:

U.S. patent application Ser. No. 15/940,636, entitled ADAPTIVE CONTROLPROGRAM UPDATES FOR SURGICAL DEVICES;

U.S. patent application Ser. No. 15/940,653, entitled ADAPTIVE CONTROLPROGRAM UPDATES FOR SURGICAL HUBS;

U.S. patent application Ser. No. 15/940,660, entitled CLOUD-BASEDMEDICAL ANALYTICS FOR CUSTOMIZATION AND RECOMMENDATIONS TO A USER;

U.S. patent application Ser. No. 15/940,679, entitled CLOUD-BASEDMEDICAL ANALYTICS FOR LINKING OF LOCAL USAGE TRENDS WITH THE RESOURCEACQUISITION BEHAVIORS OF LARGER DATA SET;

U.S. patent application Ser. No. 15/940,694, entitled CLOUD-BASEDMEDICAL ANALYTICS FOR MEDICAL FACILITY SEGMENTED INDIVIDUALIZATION OFINSTRUMENT FUNCTION;

U.S. patent application Ser. No. 15/940,634, entitled CLOUD-BASEDMEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND REACTIVEMEASURES;

U.S. patent application Ser. No. 15/940,706, entitled DATA HANDLING ANDPRIORITIZATION IN A CLOUD ANALYTICS NETWORK; and

U.S. patent application Ser. No. 15/940,675, entitled CLOUD INTERFACEFOR COUPLED SURGICAL DEVICES.

Applicant of the present application owns the following U.S. patentapplications, filed on Mar. 29, 2018, each of which is hereinincorporated by reference in its entirety:

U.S. patent application Ser. No. 15/940,627, entitled DRIVE ARRANGEMENTSFOR ROBOT-ASSISTED SURGICAL PLATFORMS;

U.S. patent application Ser. No. 15/940,637, entitled COMMUNICATIONARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS;

U.S. patent application Ser. No. 15/940,642, entitled CONTROLS FORROBOT-ASSISTED SURGICAL PLATFORMS;

U.S. patent application Ser. No. 15/940,676, entitled AUTOMATIC TOOLADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS;

U.S. patent application Ser. No. 15/940,680, entitled CONTROLLERS FORROBOT-ASSISTED SURGICAL PLATFORMS;

U.S. patent application Ser. No. 15/940,683, entitled COOPERATIVESURGICAL ACTIONS FOR ROBOT-ASSISTED SURGICAL PLATFORMS;

U.S. patent application Ser. No. 15/940,690, entitled DISPLAYARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS; and

U.S. patent application Ser. No. 15/940,711, entitled SENSINGARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS.

Applicant of the present application owns the following U.S. Provisionalpatent applications, filed on Mar. 30, 2018, each of which is hereinincorporated by reference in its entirety:

U.S. Provisional Patent Application Ser. No. 62/650,887, entitledSURGICAL SYSTEMS WITH OPTIMIZED SENSING CAPABILITIES;

U.S. Provisional Patent Application Ser. No. 62/650,877, entitledSURGICAL SMOKE EVACUATION SENSING AND CONTROLS;

U.S. Provisional Patent Application Ser. No. 62/650,882, entitled SMOKEEVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM; and

U.S. Provisional Patent Application Ser. No. 62/650,898, entitledCAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS.

Applicant of the present application owns the following U.S. ProvisionalPatent Application, filed on Apr. 19, 2018, which is herein incorporatedby reference in its entirety:

U.S. Provisional Patent Application Ser. No. 62/659,900, entitled METHODOF HUB COMMUNICATION.

Numerous specific details are set forth to provide a thoroughunderstanding of the overall structure, function, manufacture, and useof the embodiments as described in the specification and illustrated inthe accompanying drawings. Well-known operations, components, andelements have not been described in detail so as not to obscure theembodiments described in the specification. The reader will understandthat the embodiments described and illustrated herein are non-limitingexamples, and thus it can be appreciated that the specific structuraland functional details disclosed herein may be representative andillustrative. Variations and changes thereto may be made withoutdeparting from the scope of the claims.

The terms “comprise” (and any form of comprise, such as “comprises” and“comprising”), “have” (and any form of have, such as “has” and“having”), “include” (and any form of include, such as “includes” and“including”), and “contain” (and any form of contain, such as “contains”and “containing”) are open-ended linking verbs. As a result, a surgicalsystem, device, or apparatus that “comprises,” “has,” “includes”, or“contains” one or more elements possesses those one or more elements,but is not limited to possessing only those one or more elements.Likewise, an element of a system, device, or apparatus that “comprises,”“has,” “includes”, or “contains” one or more features possesses thoseone or more features, but is not limited to possessing only those one ormore features.

The terms “proximal” and “distal” are used herein with reference to aclinician manipulating the handle portion of the surgical instrument.The term “proximal” refers to the portion closest to the clinician andthe term “distal” refers to the portion located away from the clinician.It will be further appreciated that, for convenience and clarity,spatial terms such as “vertical”, “horizontal”, “up”, and “down” may beused herein with respect to the drawings. However, surgical instrumentsare used in many orientations and positions, and these terms are notintended to be limiting and/or absolute.

Various exemplary devices and methods are provided for performinglaparoscopic and minimally invasive surgical procedures. However, thereader will readily appreciate that the various methods and devicesdisclosed herein can be used in numerous surgical procedures andapplications including, for example, in connection with open surgicalprocedures. As the present Detailed Description proceeds, the readerwill further appreciate that the various instruments disclosed hereincan be inserted into a body in any way, such as through a naturalorifice, through an incision or puncture hole formed in tissue, etc. Theworking portions or end effector portions of the instruments can beinserted directly into a patient's body or can be inserted through anaccess device that has a working channel through which the end effectorand elongate shaft of a surgical instrument can be advanced.

Before explaining various aspects of surgical devices and generators indetail, it should be noted that the illustrative examples are notlimited in application or use to the details of construction andarrangement of parts illustrated in the accompanying drawings anddescription. The illustrative examples may be implemented orincorporated in other aspects, variations and modifications, and may bepracticed or carried out in various ways. Further, unless otherwiseindicated, the terms and expressions employed herein have been chosenfor the purpose of describing the illustrative examples for theconvenience of the reader and are not for the purpose of limitationthereof. Also, it will be appreciated that one or more of thefollowing-described aspects, expressions of aspects, and/or examples,can be combined with any one or more of the other following-describedaspects, expressions of aspects and/or examples.

Aspects of the present disclosure are presented for a comprehensivedigital medical system capable of spanning multiple medical facilitiesand configured to provide integrated and comprehensive improved medicalcare to a vast number of patients. The comprehensive digital medicalsystem includes a cloud-based medical analytics system that isconfigured to interconnect to multiple surgical hubs located across manydifferent medical facilities. The surgical hubs are configured tointerconnect with one or more surgical devices that are used to conductmedical procedures on patients. The surgical hubs provide a wide arrayof functionality to improve the outcomes of medical procedures. The datagenerated by the various surgical devices and medical hubs about thepatient and the medical procedure may be transmitted to the cloud-basedmedical analytics system. This data may then be aggregated with similardata gathered from many other surgical hubs and surgical devices locatedat other medical facilities. Various patterns and correlations may befound through the cloud-based analytics system analyzing the collecteddata. Improvements in the techniques used to generate the data may begenerated as a result, and these improvements may then be disseminatedto the various surgical hubs and surgical devices. Due to theinterconnectedness of all of the aforementioned components, improvementsin medical procedures and practices may be found that otherwise may notbe found if the many components were not so interconnected. Variousexamples of structures and functions of these various components will bedescribed in more detail in the following description.

Referring to FIG. 1, a computer-implemented interactive surgical system100 includes one or more surgical systems 102 and a cloud-based system(e.g., the cloud 104 that may include a remote server 113 coupled to astorage device 105). Each surgical system 102 includes at least onesurgical hub 106 in communication with the cloud 104 that may include aremote server 113. In one example, as illustrated in FIG. 1, thesurgical system 102 includes a visualization system 108, a roboticsystem 110, and a handheld intelligent surgical instrument 112, whichare configured to communicate with one another and/or the hub 106. Insome aspects, a surgical system 102 may include an M number of hubs 106,an N number of visualization systems 108, an O number of robotic systems110, and a P number of handheld intelligent surgical instruments 112,where M, N, O, and P are integers greater than or equal to one.

FIG. 3 depicts an example of a surgical system 102 being used to performa surgical procedure on a patient who is lying down on an operatingtable 114 in a surgical operating room 116. A robotic system 110 is usedin the surgical procedure as a part of the surgical system 102. Therobotic system 110 includes a surgeon's console 118, a patient side cart120 (surgical robot), and a surgical robotic hub 122. The patient sidecart 120 can manipulate at least one removably coupled surgical tool 117through a minimally invasive incision in the body of the patient whilethe surgeon views the surgical site through the surgeon's console 118.An image of the surgical site can be obtained by a medical imagingdevice 124, which can be manipulated by the patient side cart 120 toorient the imaging device 124. The robotic hub 122 can be used toprocess the images of the surgical site for subsequent display to thesurgeon through the surgeon's console 118.

Other types of robotic systems can be readily adapted for use with thesurgical system 102. Various examples of robotic systems and surgicaltools that are suitable for use with the present disclosure aredescribed in U.S. Provisional Patent Application Ser. No. 62/611,339,titled ROBOT ASSISTED SURGICAL PLATFORM, filed Dec. 28, 2017, thedisclosure of which is herein incorporated by reference in its entirety.

Various examples of cloud-based analytics that are performed by thecloud 104, and are suitable for use with the present disclosure, aredescribed in U.S. Provisional Patent Application Ser. No. 62/611,340,titled CLOUD-BASED MEDICAL ANALYTICS, filed Dec. 28, 2017, thedisclosure of which is herein incorporated by reference in its entirety.

In various aspects, the imaging device 124 includes at least one imagesensor and one or more optical components. Suitable image sensorsinclude, but are not limited to, Charge-Coupled Device (CCD) sensors andComplementary Metal-Oxide Semiconductor (CMOS) sensors.

The optical components of the imaging device 124 may include one or moreillumination sources and/or one or more lenses. The one or moreillumination sources may be directed to illuminate portions of thesurgical field. The one or more image sensors may receive lightreflected or refracted from the surgical field, including lightreflected or refracted from tissue and/or surgical instruments.

The one or more illumination sources may be configured to radiateelectromagnetic energy in the visible spectrum as well as the invisiblespectrum. The visible spectrum, sometimes referred to as the opticalspectrum or luminous spectrum, is that portion of the electromagneticspectrum that is visible to (i.e., can be detected by) the human eye andmay be referred to as visible light or simply light. A typical human eyewill respond to wavelengths in air that are from about 380 nm to about750 nm.

The invisible spectrum (i.e., the non-luminous spectrum) is that portionof the electromagnetic spectrum that lies below and above the visiblespectrum (i.e., wavelengths below about 380 nm and above about 750 nm).The invisible spectrum is not detectable by the human eye. Wavelengthsgreater than about 750 nm are longer than the red visible spectrum, andthey become invisible infrared (IR), microwave, and radioelectromagnetic radiation. Wavelengths less than about 380 nm areshorter than the violet spectrum, and they become invisible ultraviolet,x-ray, and gamma ray electromagnetic radiation.

In various aspects, the imaging device 124 is configured for use in aminimally invasive procedure. Examples of imaging devices suitable foruse with the present disclosure include, but not limited to, anarthroscope, angioscope, bronchoscope, choledochoscope, colonoscope,cytoscope, duodenoscope, enteroscope, esophagogastro-duodenoscope(gastroscope), endoscope, laryngoscope, nasopharyngo-neproscope,sigmoidoscope, thoracoscope, and ureteroscope.

In one aspect, the imaging device employs multi-spectrum monitoring todiscriminate topography and underlying structures. A multi-spectralimage is one that captures image data within specific wavelength rangesacross the electromagnetic spectrum. The wavelengths may be separated byfilters or by the use of instruments that are sensitive to particularwavelengths, including light from frequencies beyond the visible lightrange, e.g., IR and ultraviolet. Spectral imaging can allow extractionof additional information the human eye fails to capture with itsreceptors for red, green, and blue. The use of multi-spectral imaging isdescribed in greater detail under the heading “Advanced ImagingAcquisition Module” in U.S. Provisional Patent Application Ser. No.62/611,341, titled INTERACTIVE SURGICAL PLATFORM, filed Dec. 28, 2017,the disclosure of which is herein incorporated by reference in itsentirety. Multi-spectrum monitoring can be a useful tool in relocating asurgical field after a surgical task is completed to perform one or moreof the previously described tests on the treated tissue.

It is axiomatic that strict sterilization of the operating room andsurgical equipment is required during any surgery. The strict hygieneand sterilization conditions required in a “surgical theater,” i.e., anoperating or treatment room, necessitate the highest possible sterilityof all medical devices and equipment. Part of that sterilization processis the need to sterilize anything that comes in contact with the patientor penetrates the sterile field, including the imaging device 124 andits attachments and components. It will be appreciated that the sterilefield may be considered a specified area, such as within a tray or on asterile towel, that is considered free of microorganisms, or the sterilefield may be considered an area, immediately around a patient, who hasbeen prepared for a surgical procedure. The sterile field may includethe scrubbed team members, who are properly attired, and all furnitureand fixtures in the area.

In various aspects, the visualization system 108 includes one or moreimaging sensors, one or more image-processing units, one or more storagearrays, and one or more displays that are strategically arranged withrespect to the sterile field, as illustrated in FIG. 2. In one aspect,the visualization system 108 includes an interface for HL7, PACS, andEMR. Various components of the visualization system 108 are describedunder the heading “Advanced Imaging Acquisition Module” in U.S.Provisional Patent Application Ser. No. 62/611,341, titled INTERACTIVESURGICAL PLATFORM, filed Dec. 28, 2017, the disclosure of which isherein incorporated by reference in its entirety.

As illustrated in FIG. 2, a primary display 119 is positioned in thesterile field to be visible to an operator at the operating table 114.In addition, a visualization tower 111 is positioned outside the sterilefield. The visualization tower 111 includes a first non-sterile display107 and a second non-sterile display 109, which face away from eachother. The visualization system 108, guided by the hub 106, isconfigured to utilize the displays 107, 109, and 119 to coordinateinformation flow to operators inside and outside the sterile field. Forexample, the hub 106 may cause the visualization system 108 to display asnapshot of a surgical site, as recorded by an imaging device 124, on anon-sterile display 107 or 109, while maintaining a live feed of thesurgical site on the primary display 119. The snapshot on thenon-sterile display 107 or 109 can permit a non-sterile operator toperform a diagnostic step relevant to the surgical procedure, forexample.

In one aspect, the hub 106 is also configured to route a diagnosticinput or feedback entered by a non-sterile operator at the visualizationtower 111 to the primary display 119 within the sterile field, where itcan be viewed by a sterile operator at the operating table. In oneexample, the input can be in the form of a modification to the snapshotdisplayed on the non-sterile display 107 or 109, which can be routed tothe primary display 119 by the hub 106.

Referring to FIG. 2, a surgical instrument 112 is being used in thesurgical procedure as part of the surgical system 102. The hub 106 isalso configured to coordinate information flow to a display of thesurgical instrument 112. For example, in U.S. Provisional PatentApplication Ser. No. 62/611,341, titled INTERACTIVE SURGICAL PLATFORM,filed Dec. 28, 2017, the disclosure of which is herein incorporated byreference in its entirety. A diagnostic input or feedback entered by anon-sterile operator at the visualization tower 111 can be routed by thehub 106 to the surgical instrument display 115 within the sterile field,where it can be viewed by the operator of the surgical instrument 112.Example surgical instruments that are suitable for use with the surgicalsystem 102 are described under the heading “Surgical InstrumentHardware” and in U.S. Provisional Patent Application Ser. No.62/611,341, titled INTERACTIVE SURGICAL PLATFORM, filed Dec. 28, 2017,the disclosure of which is herein incorporated by reference in itsentirety, for example.

Referring now to FIG. 3, a hub 106 is depicted in communication with avisualization system 108, a robotic system 110, and a handheldintelligent surgical instrument 112. The hub 106 includes a hub display135, an imaging module 138, a generator module 140, a communicationmodule 130, a processor module 132, and a storage array 134. In certainaspects, as illustrated in FIG. 3, the hub 106 further includes a smokeevacuation module 126 and/or a suction/irrigation module 128.

During a surgical procedure, energy application to tissue, for sealingand/or cutting, is generally associated with smoke evacuation, suctionof excess fluid, and/or irrigation of the tissue. Fluid, power, and/ordata lines from different sources are often entangled during thesurgical procedure. Valuable time can be lost addressing this issueduring a surgical procedure. Detangling the lines may necessitatedisconnecting the lines from their respective modules, which may requireresetting the modules. The hub modular enclosure 136 offers a unifiedenvironment for managing the power, data, and fluid lines, which reducesthe frequency of entanglement between such lines.

Aspects of the present disclosure present a surgical hub for use in asurgical procedure that involves energy application to tissue at asurgical site. The surgical hub includes a hub enclosure and a combogenerator module slidably receivable in a docking station of the hubenclosure. The docking station includes data and power contacts. Thecombo generator module includes two or more of an ultrasonic energygenerator component, a bipolar RF energy generator component, and amonopolar RF energy generator component that are housed in a singleunit. In one aspect, the combo generator module also includes a smokeevacuation component, at least one energy delivery cable for connectingthe combo generator module to a surgical instrument, at least one smokeevacuation component configured to evacuate smoke, fluid, and/orparticulates generated by the application of therapeutic energy to thetissue, and a fluid line extending from the remote surgical site to thesmoke evacuation component.

In one aspect, the fluid line is a first fluid line and a second fluidline extends from the remote surgical site to a suction and irrigationmodule slidably received in the hub enclosure. In one aspect, the hubenclosure comprises a fluid interface.

Certain surgical procedures may require the application of more than oneenergy type to the tissue. One energy type may be more beneficial forcutting the tissue, while another different energy type may be morebeneficial for sealing the tissue. For example, a bipolar generator canbe used to seal the tissue while an ultrasonic generator can be used tocut the sealed tissue. Aspects of the present disclosure present asolution where a hub modular enclosure 136 is configured to accommodatedifferent generators, and facilitate an interactive communicationtherebetween. One of the advantages of the hub modular enclosure 136 isenabling the quick removal and/or replacement of various modules.

Aspects of the present disclosure present a modular surgical enclosurefor use in a surgical procedure that involves energy application totissue. The modular surgical enclosure includes a first energy-generatormodule, configured to generate a first energy for application to thetissue, and a first docking station comprising a first docking port thatincludes first data and power contacts, wherein the firstenergy-generator module is slidably movable into an electricalengagement with the power and data contacts and wherein the firstenergy-generator module is slidably movable out of the electricalengagement with the first power and data contacts,

Further to the above, the modular surgical enclosure also includes asecond energy-generator module configured to generate a second energy,different than the first energy, for application to the tissue, and asecond docking station comprising a second docking port that includessecond data and power contacts, wherein the second energy-generatormodule is slidably movable into an electrical engagement with the powerand data contacts, and wherein the second energy-generator module isslidably movable out of the electrical engagement with the second powerand data contacts.

In addition, the modular surgical enclosure also includes acommunication bus between the first docking port and the second dockingport, configured to facilitate communication between the firstenergy-generator module and the second energy-generator module.

Referring to FIGS. 3-7, aspects of the present disclosure are presentedfor a hub modular enclosure 136 that allows the modular integration of agenerator module 140, a smoke evacuation module 126, and asuction/irrigation module 128. The hub modular enclosure 136 furtherfacilitates interactive communication between the modules 140, 126, 128.As illustrated in FIG. 5, the generator module 140 can be a generatormodule with integrated monopolar, bipolar, and ultrasonic componentssupported in a single housing unit 139 slidably insertable into the hubmodular enclosure 136. As illustrated in FIG. 5, the generator module140 can be configured to connect to a monopolar device 146, a bipolardevice 147, and an ultrasonic device 148. Alternatively, the generatormodule 140 may comprise a series of monopolar, bipolar, and/orultrasonic generator modules that interact through the hub modularenclosure 136. The hub modular enclosure 136 can be configured tofacilitate the insertion of multiple generators and interactivecommunication between the generators docked into the hub modularenclosure 136 so that the generators would act as a single generator.

In one aspect, the hub modular enclosure 136 comprises a modular powerand communication backplane 149 with external and wireless communicationheaders to enable the removable attachment of the modules 140, 126, 128and interactive communication therebetween.

In one aspect, the hub modular enclosure 136 includes docking stations,or drawers, 151, herein also referred to as drawers, which areconfigured to slidably receive the modules 140, 126, 128. FIG. 4illustrates a partial perspective view of a surgical hub enclosure 136,and a combo generator module 145 slidably receivable in a dockingstation 151 of the surgical hub enclosure 136. A docking port 152 withpower and data contacts on a rear side of the combo generator module 145is configured to engage a corresponding docking port 150 with power anddata contacts of a corresponding docking station 151 of the hub modularenclosure 136 as the combo generator module 145 is slid into positionwithin the corresponding docking station 151 of the hub module enclosure136. In one aspect, the combo generator module 145 includes a bipolar,ultrasonic, and monopolar module and a smoke evacuation moduleintegrated together into a single housing unit 139, as illustrated inFIG. 5.

In various aspects, the smoke evacuation module 126 includes a fluidline 154 that conveys captured/collected smoke and/or fluid away from asurgical site and to, for example, the smoke evacuation module 126.Vacuum suction originating from the smoke evacuation module 126 can drawthe smoke into an opening of a utility conduit at the surgical site. Theutility conduit, coupled to the fluid line, can be in the form of aflexible tube terminating at the smoke evacuation module 126. Theutility conduit and the fluid line define a fluid path extending towardthe smoke evacuation module 126 that is received in the hub enclosure136.

In various aspects, the suction/irrigation module 128 is coupled to asurgical tool comprising an aspiration fluid line and a suction fluidline. In one example, the aspiration and suction fluid lines are in theform of flexible tubes extending from the surgical site toward thesuction/irrigation module 128. One or more drive systems can beconfigured to cause irrigation and aspiration of fluids to and from thesurgical site.

In one aspect, the surgical tool includes a shaft having an end effectorat a distal end thereof and at least one energy treatment associatedwith the end effector, an aspiration tube, and an irrigation tube. Theaspiration tube can have an inlet port at a distal end thereof and theaspiration tube extends through the shaft. Similarly, an irrigation tubecan extend through the shaft and can have an inlet port in proximity tothe energy deliver implement. The energy deliver implement is configuredto deliver ultrasonic and/or RF energy to the surgical site and iscoupled to the generator module 140 by a cable extending initiallythrough the shaft.

The irrigation tube can be in fluid communication with a fluid source,and the aspiration tube can be in fluid communication with a vacuumsource. The fluid source and/or the vacuum source can be housed in thesuction/irrigation module 128. In one example, the fluid source and/orthe vacuum source can be housed in the hub enclosure 136 separately fromthe suction/irrigation module 128. In such example, a fluid interfacecan be configured to connect the suction/irrigation module 128 to thefluid source and/or the vacuum source.

In one aspect, the modules 140, 126, 128 and/or their correspondingdocking stations on the hub modular enclosure 136 may include alignmentfeatures that are configured to align the docking ports of the modulesinto engagement with their counterparts in the docking stations of thehub modular enclosure 136. For example, as illustrated in FIG. 4, thecombo generator module 145 includes side brackets 155 that areconfigured to slidably engage with corresponding brackets 156 of thecorresponding docking station 151 of the hub modular enclosure 136. Thebrackets cooperate to guide the docking port contacts of the combogenerator module 145 into an electrical engagement with the docking portcontacts of the hub modular enclosure 136.

In some aspects, the drawers 151 of the hub modular enclosure 136 arethe same, or substantially the same size, and the modules are adjustedin size to be received in the drawers 151. For example, the sidebrackets 155 and/or 156 can be larger or smaller depending on the sizeof the module. In other aspects, the drawers 151 are different in sizeand are each designed to accommodate a particular module.

Furthermore, the contacts of a particular module can be keyed forengagement with the contacts of a particular drawer to avoid inserting amodule into a drawer with mismatching contacts.

As illustrated in FIG. 4, the docking port 150 of one drawer 151 can becoupled to the docking port 150 of another drawer 151 through acommunications link 157 to facilitate an interactive communicationbetween the modules housed in the hub modular enclosure 136. The dockingports 150 of the hub modular enclosure 136 may alternatively, oradditionally, facilitate a wireless interactive communication betweenthe modules housed in the hub modular enclosure 136. Any suitablewireless communication can be employed, such as for example AirTitan-Bluetooth.

FIG. 6 illustrates individual power bus attachments for a plurality oflateral docking ports of a lateral modular housing 160 configured toreceive a plurality of modules of a surgical hub 206. The lateralmodular housing 160 is configured to laterally receive and interconnectthe modules 161. The modules 161 are slidably inserted into dockingstations 162 of lateral modular housing 160, which includes a backplanefor interconnecting the modules 161. As illustrated in FIG. 6, themodules 161 are arranged laterally in the lateral modular housing 160.Alternatively, the modules 161 may be arranged vertically in a lateralmodular housing.

FIG. 7 illustrates a vertical modular housing 164 configured to receivea plurality of modules 165 of the surgical hub 106. The modules 165 areslidably inserted into docking stations, or drawers, 167 of verticalmodular housing 164, which includes a backplane for interconnecting themodules 165. Although the drawers 167 of the vertical modular housing164 are arranged vertically, in certain instances, a vertical modularhousing 164 may include drawers that are arranged laterally.Furthermore, the modules 165 may interact with one another through thedocking ports of the vertical modular housing 164. In the example ofFIG. 7, a display 177 is provided for displaying data relevant to theoperation of the modules 165. In addition, the vertical modular housing164 includes a master module 178 housing a plurality of sub-modules thatare slidably received in the master module 178.

In various aspects, the imaging module 138 comprises an integrated videoprocessor and a modular light source and is adapted for use with variousimaging devices. In one aspect, the imaging device is comprised of amodular housing that can be assembled with a light source module and acamera module. The housing can be a disposable housing. In at least oneexample, the disposable housing is removably coupled to a reusablecontroller, a light source module, and a camera module. The light sourcemodule and/or the camera module can be selectively chosen depending onthe type of surgical procedure. In one aspect, the camera modulecomprises a CCD sensor. In another aspect, the camera module comprises aCMOS sensor. In another aspect, the camera module is configured forscanned beam imaging. Likewise, the light source module can beconfigured to deliver a white light or a different light, depending onthe surgical procedure.

During a surgical procedure, removing a surgical device from thesurgical field and replacing it with another surgical device thatincludes a different camera or a different light source can beinefficient. Temporarily losing sight of the surgical field may lead toundesirable consequences. The module imaging device of the presentdisclosure is configured to permit the replacement of a light sourcemodule or a camera module midstream during a surgical procedure, withouthaving to remove the imaging device from the surgical field.

In one aspect, the imaging device comprises a tubular housing thatincludes a plurality of channels. A first channel is configured toslidably receive the camera module, which can be configured for asnap-fit engagement with the first channel. A second channel isconfigured to slidably receive the light source module, which can beconfigured for a snap-fit engagement with the second channel. In anotherexample, the camera module and/or the light source module can be rotatedinto a final position within their respective channels. A threadedengagement can be employed in lieu of the snap-fit engagement.

In various examples, multiple imaging devices are placed at differentpositions in the surgical field to provide multiple views. The imagingmodule 138 can be configured to switch between the imaging devices toprovide an optimal view. In various aspects, the imaging module 138 canbe configured to integrate the images from the different imaging device.

Various image processors and imaging devices suitable for use with thepresent disclosure are described in U.S. Pat. No. 7,995,045, titledCOMBINED SBI AND CONVENTIONAL IMAGE PROCESSOR, which issued on Aug. 9,2011, which is herein incorporated by reference in its entirety. Inaddition, U.S. Pat. No. 7,982,776, titled SBI MOTION ARTIFACT REMOVALAPPARATUS AND METHOD, which issued on Jul. 19, 2011, which is hereinincorporated by reference in its entirety, describes various systems forremoving motion artifacts from image data. Such systems can beintegrated with the imaging module 138. Furthermore, U.S. PatentApplication Publication No. 2011/0306840, titled CONTROLLABLE MAGNETICSOURCE TO FIXTURE INTRACORPOREAL APPARATUS, which published on Dec. 15,2011, and U.S. Patent Application Publication No. 2014/0243597, titledSYSTEM FOR PERFORMING A MINIMALLY INVASIVE SURGICAL PROCEDURE, whichpublished on Aug. 28, 2014, each of which is herein incorporated byreference in its entirety.

FIG. 8 illustrates a surgical data network 201 comprising a modularcommunication hub 203 configured to connect modular devices located inone or more operating theaters of a healthcare facility, or any room ina healthcare facility specially equipped for surgical operations, to acloud-based system (e.g., the cloud 204 that may include a remote server213 coupled to a storage device 205). In one aspect, the modularcommunication hub 203 comprises a network hub 207 and/or a networkswitch 209 in communication with a network router. The modularcommunication hub 203 also can be coupled to a local computer system 210to provide local computer processing and data manipulation. The surgicaldata network 201 may be configured as passive, intelligent, orswitching. A passive surgical data network serves as a conduit for thedata, enabling it to go from one device (or segment) to another and tothe cloud computing resources. An intelligent surgical data networkincludes additional features to enable the traffic passing through thesurgical data network to be monitored and to configure each port in thenetwork hub 207 or network switch 209. An intelligent surgical datanetwork may be referred to as a manageable hub or switch. A switchinghub reads the destination address of each packet and then forwards thepacket to the correct port.

Modular devices 1 a-1 n located in the operating theater may be coupledto the modular communication hub 203. The network hub 207 and/or thenetwork switch 209 may be coupled to a network router 211 to connect thedevices 1 a-1 n to the cloud 204 or the local computer system 210. Dataassociated with the devices 1 a-1 n may be transferred to cloud-basedcomputers via the router for remote data processing and manipulation.Data associated with the devices 1 a-1 n may also be transferred to thelocal computer system 210 for local data processing and manipulation.Modular devices 2 a-2 m located in the same operating theater also maybe coupled to a network switch 209. The network switch 209 may becoupled to the network hub 207 and/or the network router 211 to connectto the devices 2 a-2 m to the cloud 204. Data associated with thedevices 2 a-2 n may be transferred to the cloud 204 via the networkrouter 211 for data processing and manipulation. Data associated withthe devices 2 a-2 m may also be transferred to the local computer system210 for local data processing and manipulation.

It will be appreciated that the surgical data network 201 may beexpanded by interconnecting multiple network hubs 207 and/or multiplenetwork switches 209 with multiple network routers 211. The modularcommunication hub 203 may be contained in a modular control towerconfigured to receive multiple devices 1 a-1 n/2 a-2 m. The localcomputer system 210 also may be contained in a modular control tower.The modular communication hub 203 is connected to a display 212 todisplay images obtained by some of the devices 1 a-1 n/2 a-2 m, forexample during surgical procedures. In various aspects, the devices 1a-1 n/2 a-2 m may include, for example, various modules such as animaging module 138 coupled to an endoscope, a generator module 140coupled to an energy-based surgical device, a smoke evacuation module126, a suction/irrigation module 128, a communication module 130, aprocessor module 132, a storage array 134, a surgical device coupled toa display, and/or a non-contact sensor module, among other modulardevices that may be connected to the modular communication hub 203 ofthe surgical data network 201.

In one aspect, the surgical data network 201 may comprise a combinationof network hub(s), network switch(es), and network router(s) connectingthe devices 1 a-1 n/2 a-2 m to the cloud. Any one of or all of thedevices 1 a-1 n/2 a-2 m coupled to the network hub or network switch maycollect data in real time and transfer the data to cloud computers fordata processing and manipulation. It will be appreciated that cloudcomputing relies on sharing computing resources rather than having localservers or personal devices to handle software applications. The word“cloud” may be used as a metaphor for “the Internet,” although the termis not limited as such. Accordingly, the term “cloud computing” may beused herein to refer to “a type of Internet-based computing,” wheredifferent services—such as servers, storage, and applications—aredelivered to the modular communication hub 203 and/or computer system210 located in the surgical theater (e.g., a fixed, mobile, temporary,or field operating room or space) and to devices connected to themodular communication hub 203 and/or computer system 210 through theInternet. The cloud infrastructure may be maintained by a cloud serviceprovider. In this context, the cloud service provider may be the entitythat coordinates the usage and control of the devices 1 a-1 n/2 a-2 mlocated in one or more operating theaters. The cloud computing servicescan perform a large number of calculations based on the data gathered bysmart surgical instruments, robots, and other computerized deviceslocated in the operating theater. The hub hardware enables multipledevices or connections to be connected to a computer that communicateswith the cloud computing resources and storage.

Applying cloud computer data processing techniques on the data collectedby the devices 1 a-1 n/2 a-2 m, the surgical data network providesimproved surgical outcomes, reduced costs, and improved patientsatisfaction. At least some of the devices 1 a-1 n/2 a-2 m may beemployed to view tissue states to assess leaks or perfusion of sealedtissue after a tissue sealing and cutting procedure. At least some ofthe devices 1 a-1 n/2 a-2 m may be employed to identify pathology, suchas the effects of diseases, using the cloud-based computing to examinedata including images of samples of body tissue for diagnostic purposes.This includes localization and margin confirmation of tissue andphenotypes. At least some of the devices 1 a-1 n/2 a-2 m may be employedto identify anatomical structures of the body using a variety of sensorsintegrated with imaging devices and techniques such as overlaying imagescaptured by multiple imaging devices. The data gathered by the devices 1a-1 n/2 a-2 m, including image data, may be transferred to the cloud 204or the local computer system 210 or both for data processing andmanipulation including image processing and manipulation. The data maybe analyzed to improve surgical procedure outcomes by determining iffurther treatment, such as the application of endoscopic intervention,emerging technologies, a targeted radiation, targeted intervention, andprecise robotics to tissue-specific sites and conditions, may bepursued. Such data analysis may further employ outcome analyticsprocessing, and using standardized approaches may provide beneficialfeedback to either confirm surgical treatments and the behavior of thesurgeon or suggest modifications to surgical treatments and the behaviorof the surgeon.

In one implementation, the operating theater devices 1 a-1 n may beconnected to the modular communication hub 203 over a wired channel or awireless channel depending on the configuration of the devices 1 a-1 nto a network hub. The network hub 207 may be implemented, in one aspect,as a local network broadcast device that works on the physical layer ofthe Open System Interconnection (OSI) model. The network hub providesconnectivity to the devices 1 a-1 n located in the same operatingtheater network. The network hub 207 collects data in the form ofpackets and sends them to the router in half duplex mode. The networkhub 207 does not store any media access control/Internet Protocol(MAC/IP) to transfer the device data. Only one of the devices 1 a-1 ncan send data at a time through the network hub 207. The network hub 207has no routing tables or intelligence regarding where to sendinformation and broadcasts all network data across each connection andto a remote server 213 (FIG. 9) over the cloud 204. The network hub 207can detect basic network errors such as collisions, but having allinformation broadcast to multiple ports can be a security risk and causebottlenecks.

In another implementation, the operating theater devices 2 a-2 m may beconnected to a network switch 209 over a wired channel or a wirelesschannel. The network switch 209 works in the data link layer of the OSImodel. The network switch 209 is a multicast device for connecting thedevices 2 a-2 m located in the same operating theater to the network.The network switch 209 sends data in the form of frames to the networkrouter 211 and works in full duplex mode. Multiple devices 2 a-2 m cansend data at the same time through the network switch 209. The networkswitch 209 stores and uses MAC addresses of the devices 2 a-2 m totransfer data.

The network hub 207 and/or the network switch 209 are coupled to thenetwork router 211 for connection to the cloud 204. The network router211 works in the network layer of the OSI model. The network router 211creates a route for transmitting data packets received from the networkhub 207 and/or network switch 211 to cloud-based computer resources forfurther processing and manipulation of the data collected by any one ofor all the devices 1 a-1 n/2 a-2 m. The network router 211 may beemployed to connect two or more different networks located in differentlocations, such as, for example, different operating theaters of thesame healthcare facility or different networks located in differentoperating theaters of different healthcare facilities. The networkrouter 211 sends data in the form of packets to the cloud 204 and worksin full duplex mode. Multiple devices can send data at the same time.The network router 211 uses IP addresses to transfer data.

In one example, the network hub 207 may be implemented as a USB hub,which allows multiple USB devices to be connected to a host computer.The USB hub may expand a single USB port into several tiers so thatthere are more ports available to connect devices to the host systemcomputer. The network hub 207 may include wired or wireless capabilitiesto receive information over a wired channel or a wireless channel. Inone aspect, a wireless USB short-range, high-bandwidth wireless radiocommunication protocol may be employed for communication between thedevices 1 a-1 n and devices 2 a-2 m located in the operating theater.

In other examples, the operating theater devices 1 a-1 n/2 a-2 m maycommunicate to the modular communication hub 203 via Bluetooth wirelesstechnology standard for exchanging data over short distances (usingshort-wavelength UHF radio waves in the ISM band from 2.4 to 2.485 GHz)from fixed and mobile devices and building personal area networks(PANs). In other aspects, the operating theater devices 1 a-1 n/2 a-2 mmay communicate to the modular communication hub 203 via a number ofwireless or wired communication standards or protocols, including butnot limited to Wi-Fi (IEEE 802.11 family), WiMAX (IEEE 802.16 family),IEEE 802.20, long-term evolution (LTE), and Ev-DO, HSPA+, HSDPA+,HSUPA+, EDGE, GSM, GPRS, CDMA, TDMA, DECT, and Ethernet derivativesthereof, as well as any other wireless and wired protocols that aredesignated as 3G, 4G, 5G, and beyond. The computing module may include aplurality of communication modules. For instance, a first communicationmodule may be dedicated to shorter-range wireless communications such asWi-Fi and Bluetooth, and a second communication module may be dedicatedto longer-range wireless communications such as GPS, EDGE, GPRS, CDMA,WiMAX, LTE, Ev-DO, and others.

The modular communication hub 203 may serve as a central connection forone or all of the operating theater devices 1 a-1 n/2 a-2 m and handlesa data type known as frames. Frames carry the data generated by thedevices 1 a-1 n/2 a-2 m. When a frame is received by the modularcommunication hub 203, it is amplified and transmitted to the networkrouter 211, which transfers the data to the cloud computing resources byusing a number of wireless or wired communication standards orprotocols, as described herein.

The modular communication hub 203 can be used as a standalone device orbe connected to compatible network hubs and network switches to form alarger network. The modular communication hub 203 is generally easy toinstall, configure, and maintain, making it a good option for networkingthe operating theater devices 1 a-1 n/2 a-2 m.

FIG. 9 illustrates a computer-implemented interactive surgical system200. The computer-implemented interactive surgical system 200 is similarin many respects to the computer-implemented interactive surgical system100. For example, the computer-implemented interactive surgical system200 includes one or more surgical systems 202, which are similar in manyrespects to the surgical systems 102. Each surgical system 202 includesat least one surgical hub 206 in communication with a cloud 204 that mayinclude a remote server 213. In one aspect, the computer-implementedinteractive surgical system 200 comprises a modular control tower 236connected to multiple operating theater devices such as, for example,intelligent surgical instruments, robots, and other computerized deviceslocated in the operating theater. As shown in FIG. 10, the modularcontrol tower 236 comprises a modular communication hub 203 coupled to acomputer system 210. As illustrated in the example of FIG. 9, themodular control tower 236 is coupled to an imaging module 238 that iscoupled to an endoscope 239, a generator module 240 that is coupled toan energy device 241, a smoke evacuator module 226, a suction/irrigationmodule 228, a communication module 230, a processor module 232, astorage array 234, a smart device/instrument 235 optionally coupled to adisplay 237, and a non-contact sensor module 242. The operating theaterdevices are coupled to cloud computing resources and data storage viathe modular control tower 236. A robot hub 222 also may be connected tothe modular control tower 236 and to the cloud computing resources. Thedevices/instruments 235, visualization systems 208, among others, may becoupled to the modular control tower 236 via wired or wirelesscommunication standards or protocols, as described herein. The modularcontrol tower 236 may be coupled to a hub display 215 (e.g., monitor,screen) to display and overlay images received from the imaging module,device/instrument display, and/or other visualization systems 208. Thehub display also may display data received from devices connected to themodular control tower in conjunction with images and overlaid images.

FIG. 10 illustrates a surgical hub 206 comprising a plurality of modulescoupled to the modular control tower 236. The modular control tower 236comprises a modular communication hub 203, e.g., a network connectivitydevice, and a computer system 210 to provide local processing,visualization, and imaging, for example. As shown in FIG. 10, themodular communication hub 203 may be connected in a tiered configurationto expand the number of modules (e.g., devices) that may be connected tothe modular communication hub 203 and transfer data associated with themodules to the computer system 210, cloud computing resources, or both.As shown in FIG. 10, each of the network hubs/switches in the modularcommunication hub 203 includes three downstream ports and one upstreamport. The upstream network hub/switch is connected to a processor toprovide a communication connection to the cloud computing resources anda local display 217. Communication to the cloud 204 may be made eitherthrough a wired or a wireless communication channel.

The surgical hub 206 employs a non-contact sensor module 242 to measurethe dimensions of the operating theater and generate a map of thesurgical theater using either ultrasonic or laser-type non-contactmeasurement devices. An ultrasound-based non-contact sensor module scansthe operating theater by transmitting a burst of ultrasound andreceiving the echo when it bounces off the perimeter walls of anoperating theater as described under the heading “Surgical Hub SpatialAwareness Within an Operating Room” in U.S. Provisional PatentApplication Ser. No. 62/611,341, titled INTERACTIVE SURGICAL PLATFORM,filed Dec. 28, 2017, which is herein incorporated by reference in itsentirety, in which the sensor module is configured to determine the sizeof the operating theater and to adjust Bluetooth-pairing distancelimits. A laser-based non-contact sensor module scans the operatingtheater by transmitting laser light pulses, receiving laser light pulsesthat bounce off the perimeter walls of the operating theater, andcomparing the phase of the transmitted pulse to the received pulse todetermine the size of the operating theater and to adjust Bluetoothpairing distance limits, for example.

The computer system 210 comprises a processor 244 and a networkinterface 245. The processor 244 is coupled to a communication module247, storage 248, memory 249, non-volatile memory 250, and input/outputinterface 251 via a system bus. The system bus can be any of severaltypes of bus structure(s) including the memory bus or memory controller,a peripheral bus or external bus, and/or a local bus using any varietyof available bus architectures including, but not limited to, 9-bit bus,Industrial Standard Architecture (ISA), Micro-Charmel Architecture(MSA), Extended ISA (EISA), Intelligent Drive Electronics (IDE), VESALocal Bus (VLB), Peripheral Component Interconnect (PCI), USB, AdvancedGraphics Port (AGP), Personal Computer Memory Card InternationalAssociation bus (PCMCIA), Small Computer Systems Interface (SCSI), orany other proprietary bus.

The processor 244 may be any single-core or multicore processor such asthose known under the trade name ARM Cortex by Texas Instruments. In oneaspect, the processor may be an LM4F230H5QR ARM Cortex-M4F ProcessorCore, available from Texas Instruments, for example, comprising anon-chip memory of 256 KB single-cycle flash memory, or othernon-volatile memory, up to 40 MHz, a prefetch buffer to improveperformance above 40 MHz, a 32 KB single-cycle serial random accessmemory (SRAM), an internal read-only memory (ROM) loaded withStellarisWare® software, a 2 KB electrically erasable programmableread-only memory (EEPROM), and/or one or more pulse width modulation(PWM) modules, one or more quadrature encoder inputs (QEI) analogs, oneor more 12-bit analog-to-digital converters (ADCs) with 12 analog inputchannels, details of which are available for the product datasheet.

In one aspect, the processor 244 may comprise a safety controllercomprising two controller-based families such as TMS570 and RM4x, knownunder the trade name Hercules ARM Cortex R4, also by Texas Instruments.The safety controller may be configured specifically for IEC 61508 andISO 26262 safety critical applications, among others, to provideadvanced integrated safety features while delivering scalableperformance, connectivity, and memory options.

The system memory includes volatile memory and non-volatile memory. Thebasic input/output system (BIOS), containing the basic routines totransfer information between elements within the computer system, suchas during start-up, is stored in non-volatile memory. For example, thenon-volatile memory can include ROM, programmable ROM (PROM),electrically programmable ROM (EPROM), EEPROM, or flash memory. Volatilememory includes random-access memory (RAM), which acts as external cachememory. Moreover, RAM is available in many forms such as SRAM, dynamicRAM (DRAM), synchronous DRAM (SDRAM), double data rate SDRAM (DDRSDRAM), enhanced SDRAM (ESDRAM), Synchlink DRAM (SLDRAM), and directRambus RAM (DRRAM).

The computer system 210 also includes removable/non-removable,volatile/non-volatile computer storage media, such as for example diskstorage. The disk storage includes, but is not limited to, devices likea magnetic disk drive, floppy disk drive, tape drive, Jaz drive, Zipdrive, LS-60 drive, flash memory card, or memory stick. In addition, thedisk storage can include storage media separately or in combination withother storage media including, but not limited to, an optical disc drivesuch as a compact disc ROM device (CD-ROM), compact disc recordabledrive (CD-R Drive), compact disc rewritable drive (CD-RW Drive), or adigital versatile disc ROM drive (DVD-ROM). To facilitate the connectionof the disk storage devices to the system bus, a removable ornon-removable interface may be employed.

It is to be appreciated that the computer system 210 includes softwarethat acts as an intermediary between users and the basic computerresources described in a suitable operating environment. Such softwareincludes an operating system. The operating system, which can be storedon the disk storage, acts to control and allocate resources of thecomputer system. System applications take advantage of the management ofresources by the operating system through program modules and programdata stored either in the system memory or on the disk storage. It is tobe appreciated that various components described herein can beimplemented with various operating systems or combinations of operatingsystems.

A user enters commands or information into the computer system 210through input device(s) coupled to the I/O interface 251. The inputdevices include, but are not limited to, a pointing device such as amouse, trackball, stylus, touch pad, keyboard, microphone, joystick,game pad, satellite dish, scanner, TV tuner card, digital camera,digital video camera, web camera, and the like. These and other inputdevices connect to the processor through the system bus via interfaceport(s). The interface port(s) include, for example, a serial port, aparallel port, a game port, and a USB. The output device(s) use some ofthe same types of ports as input device(s). Thus, for example, a USBport may be used to provide input to the computer system and to outputinformation from the computer system to an output device. An outputadapter is provided to illustrate that there are some output deviceslike monitors, displays, speakers, and printers, among other outputdevices that require special adapters. The output adapters include, byway of illustration and not limitation, video and sound cards thatprovide a means of connection between the output device and the systembus. It should be noted that other devices and/or systems of devices,such as remote computer(s), provide both input and output capabilities.

The computer system 210 can operate in a networked environment usinglogical connections to one or more remote computers, such as cloudcomputer(s), or local computers. The remote cloud computer(s) can be apersonal computer, server, router, network PC, workstation,microprocessor-based appliance, peer device, or other common networknode, and the like, and typically includes many or all of the elementsdescribed relative to the computer system. For purposes of brevity, onlya memory storage device is illustrated with the remote computer(s). Theremote computer(s) is logically connected to the computer system througha network interface and then physically connected via a communicationconnection. The network interface encompasses communication networkssuch as local area networks (LANs) and wide area networks (WANs). LANtechnologies include Fiber Distributed Data Interface (FDDI), CopperDistributed Data Interface (CDDI), Ethernet/IEEE 802.3, Token Ring/IEEE802.5 and the like. WAN technologies include, but are not limited to,point-to-point links, circuit-switching networks like IntegratedServices Digital Networks (ISDN) and variations thereon,packet-switching networks, and Digital Subscriber Lines (DSL).

In various aspects, the computer system 210 of FIG. 10, the imagingmodule 238 and/or visualization system 208, and/or the processor module232 of FIGS. 9-10, may comprise an image processor, image-processingengine, media processor, or any specialized digital signal processor(DSP) used for the processing of digital images. The image processor mayemploy parallel computing with single instruction, multiple data (SIMD)or multiple instruction, multiple data (MIMD) technologies to increasespeed and efficiency. The digital image-processing engine can perform arange of tasks. The image processor may be a system on a chip withmulticore processor architecture.

The communication connection(s) refers to the hardware/software employedto connect the network interface to the bus. While the communicationconnection is shown for illustrative clarity inside the computer system,it can also be external to the computer system 210. Thehardware/software necessary for connection to the network interfaceincludes, for illustrative purposes only, internal and externaltechnologies such as modems, including regular telephone-grade modems,cable modems, and DSL modems, ISDN adapters, and Ethernet cards.

FIG. 11 illustrates a functional block diagram of one aspect of a USBnetwork hub 300 device, according to one aspect of the presentdisclosure. In the illustrated aspect, the USB network hub device 300employs a TUSB2036 integrated circuit hub by Texas Instruments. The USBnetwork hub 300 is a CMOS device that provides an upstream USBtransceiver port 302 and up to three downstream USB transceiver ports304, 306, 308 in compliance with the USB 2.0 specification. The upstreamUSB transceiver port 302 is a differential root data port comprising adifferential data minus (DM0) input paired with a differential data plus(DP0) input. The three downstream USB transceiver ports 304, 306, 308are differential data ports where each port includes differential dataplus (DP1-DP3) outputs paired with differential data minus (DM1-DM3)outputs.

The USB network hub 300 device is implemented with a digital statemachine instead of a microcontroller, and no firmware programming isrequired. Fully compliant USB transceivers are integrated into thecircuit for the upstream USB transceiver port 302 and all downstream USBtransceiver ports 304, 306, 308. The downstream USB transceiver ports304, 306, 308 support both full-speed and low-speed devices byautomatically setting the slew rate according to the speed of the deviceattached to the ports. The USB network hub 300 device may be configuredeither in bus-powered or self-powered mode and includes a hub powerlogic 312 to manage power.

The USB network hub 300 device includes a serial interface engine 310(SIE). The SIE 310 is the front end of the USB network hub 300 hardwareand handles most of the protocol described in chapter 8 of the USBspecification. The SIE 310 typically comprehends signaling up to thetransaction level. The functions that it handles could include: packetrecognition, transaction sequencing, SOP, EOP, RESET, and RESUME signaldetection/generation, clock/data separation, non-return-to-zero invert(NRZI) data encoding/decoding and bit-stuffing, CRC generation andchecking (token and data), packet ID (PID) generation andchecking/decoding, and/or serial-parallel/parallel-serial conversion.The 310 receives a clock input 314 and is coupled to a suspend/resumelogic and frame timer 316 circuit and a hub repeater circuit 318 tocontrol communication between the upstream USB transceiver port 302 andthe downstream USB transceiver ports 304, 306, 308 through port logiccircuits 320, 322, 324. The SIE 310 is coupled to a command decoder 326via interface logic to control commands from a serial EEPROM via aserial EEPROM interface 330.

In various aspects, the USB network hub 300 can connect 127 functionsconfigured in up to six logical layers (tiers) to a single computer.Further, the USB network hub 300 can connect to all peripherals using astandardized four-wire cable that provides both communication and powerdistribution. The power configurations are bus-powered and self-poweredmodes. The USB network hub 300 may be configured to support four modesof power management: a bus-powered hub, with either individual-portpower management or ganged-port power management, and the self-poweredhub, with either individual-port power management or ganged-port powermanagement. In one aspect, using a USB cable, the USB network hub 300,the upstream USB transceiver port 302 is plugged into a USB hostcontroller, and the downstream USB transceiver ports 304, 306, 308 areexposed for connecting USB compatible devices, and so forth.

Surgical Instrument Hardware

FIG. 12 illustrates a logic diagram of a control system 470 of asurgical instrument or tool in accordance with one or more aspects ofthe present disclosure. The system 470 comprises a control circuit. Thecontrol circuit includes a microcontroller 461 comprising a processor462 and a memory 468. One or more of sensors 472, 474, 476, for example,provide real-time feedback to the processor 462. A motor 482, driven bya motor driver 492, operably couples a longitudinally movabledisplacement member to drive the I-beam knife element. A tracking system480 is configured to determine the position of the longitudinallymovable displacement member. The position information is provided to theprocessor 462, which can be programmed or configured to determine theposition of the longitudinally movable drive member as well as theposition of a firing member, firing bar, and I-beam knife element.Additional motors may be provided at the tool driver interface tocontrol I-beam firing, closure tube travel, shaft rotation, andarticulation. A display 473 displays a variety of operating conditionsof the instruments and may include touch screen functionality for datainput. Information displayed on the display 473 may be overlaid withimages acquired via endoscopic imaging modules.

In one aspect, the microcontroller 461 may be any single-core ormulticore processor such as those known under the trade name ARM Cortexby Texas Instruments. In one aspect, the main microcontroller 461 may bean LM4F230H5QR ARM Cortex-M4F Processor Core, available from TexasInstruments, for example, comprising an on-chip memory of 256 KBsingle-cycle flash memory, or other non-volatile memory, up to 40 MHz, aprefetch buffer to improve performance above 40 MHz, a 32 KBsingle-cycle SRAM, and internal ROM loaded with StellarisWare® software,a 2 KB EEPROM, one or more PWM modules, one or more QEI analogs, and/orone or more 12-bit ADCs with 12 analog input channels, details of whichare available for the product datasheet.

In one aspect, the microcontroller 461 may comprise a safety controllercomprising two controller-based families such as TMS570 and RM4x, knownunder the trade name Hercules ARM Cortex R4, also by Texas Instruments.The safety controller may be configured specifically for IEC 61508 andISO 26262 safety critical applications, among others, to provideadvanced integrated safety features while delivering scalableperformance, connectivity, and memory options.

The microcontroller 461 may be programmed to perform various functionssuch as precise control over the speed and position of the knife andarticulation systems. In one aspect, the microcontroller 461 includes aprocessor 462 and a memory 468. The electric motor 482 may be a brusheddirect current (DC) motor with a gearbox and mechanical links to anarticulation or knife system. In one aspect, a motor driver 492 may bean A3941 available from Allegro Microsystems, Inc. Other motor driversmay be readily substituted for use in the tracking system 480 comprisingan absolute positioning system. A detailed description of an absolutepositioning system is described in U.S. Patent Application PublicationNo. 2017/0296213, titled SYSTEMS AND METHODS FOR CONTROLLING A SURGICALSTAPLING AND CUTTING INSTRUMENT, which published on Oct. 19, 2017, whichis herein incorporated by reference in its entirety.

The microcontroller 461 may be programmed to provide precise controlover the speed and position of displacement members and articulationsystems. The microcontroller 461 may be configured to compute a responsein the software of the microcontroller 461. The computed response iscompared to a measured response of the actual system to obtain an“observed” response, which is used for actual feedback decisions. Theobserved response is a favorable, tuned value that balances the smooth,continuous nature of the simulated response with the measured response,which can detect outside influences on the system.

In one aspect, the motor 482 may be controlled by the motor driver 492and can be employed by the firing system of the surgical instrument ortool. In various forms, the motor 482 may be a brushed DC driving motorhaving a maximum rotational speed of approximately 25,000 RPM. In otherarrangements, the motor 482 may include a brushless motor, a cordlessmotor, a synchronous motor, a stepper motor, or any other suitableelectric motor. The motor driver 492 may comprise an H-bridge drivercomprising field-effect transistors (FETs), for example. The motor 482can be powered by a power assembly releasably mounted to the handleassembly or tool housing for supplying control power to the surgicalinstrument or tool. The power assembly may comprise a battery which mayinclude a number of battery cells connected in series that can be usedas the power source to power the surgical instrument or tool. In certaincircumstances, the battery cells of the power assembly may bereplaceable and/or rechargeable. In at least one example, the batterycells can be lithium-ion batteries which can be couplable to andseparable from the power assembly.

The motor driver 492 may be an A3941 available from AllegroMicrosystems, Inc. The A3941 492 is a full-bridge controller for usewith external N-channel power metal-oxide semiconductor field-effecttransistors (MOSFETs) specifically designed for inductive loads, such asbrush DC motors. The driver 492 comprises a unique charge pump regulatorthat provides full (>10 V) gate drive for battery voltages down to 7 Vand allows the A3941 to operate with a reduced gate drive, down to 5.5V. A bootstrap capacitor may be employed to provide the above batterysupply voltage required for N-channel MOSFETs. An internal charge pumpfor the high-side drive allows DC (100% duty cycle) operation. The fullbridge can be driven in fast or slow decay modes using diode orsynchronous rectification. In the slow decay mode, current recirculationcan be through the high-side or the lowside FETs. The power FETs areprotected from shoot-through by resistor-adjustable dead time.Integrated diagnostics provide indications of undervoltage,overtemperature, and power bridge faults and can be configured toprotect the power MOSFETs under most short circuit conditions. Othermotor drivers may be readily substituted for use in the tracking system480 comprising an absolute positioning system.

The tracking system 480 comprises a controlled motor drive circuitarrangement comprising a position sensor 472 according to one aspect ofthis disclosure. The position sensor 472 for an absolute positioningsystem provides a unique position signal corresponding to the locationof a displacement member. In one aspect, the displacement memberrepresents a longitudinally movable drive member comprising a rack ofdrive teeth for meshing engagement with a corresponding drive gear of agear reducer assembly. In other aspects, the displacement memberrepresents the firing member, which could be adapted and configured toinclude a rack of drive teeth. In yet another aspect, the displacementmember represents a firing bar or the I-beam, each of which can beadapted and configured to include a rack of drive teeth. Accordingly, asused herein, the term displacement member is used generically to referto any movable member of the surgical instrument or tool such as thedrive member, the firing member, the firing bar, the I-beam, or anyelement that can be displaced. In one aspect, the longitudinally movabledrive member is coupled to the firing member, the firing bar, and theI-beam. Accordingly, the absolute positioning system can, in effect,track the linear displacement of the I-beam by tracking the lineardisplacement of the longitudinally movable drive member. In variousother aspects, the displacement member may be coupled to any positionsensor 472 suitable for measuring linear displacement. Thus, thelongitudinally movable drive member, the firing member, the firing bar,or the I-beam, or combinations thereof, may be coupled to any suitablelinear displacement sensor. Linear displacement sensors may includecontact or non-contact displacement sensors. Linear displacement sensorsmay comprise linear variable differential transformers (LVDT),differential variable reluctance transducers (DVRT), a slidepotentiometer, a magnetic sensing system comprising a movable magnet anda series of linearly arranged Hall effect sensors, a magnetic sensingsystem comprising a fixed magnet and a series of movable, linearlyarranged Hall effect sensors, an optical sensing system comprising amovable light source and a series of linearly arranged photo diodes orphoto detectors, an optical sensing system comprising a fixed lightsource and a series of movable linearly, arranged photo diodes or photodetectors, or any combination thereof.

The electric motor 482 can include a rotatable shaft that operablyinterfaces with a gear assembly that is mounted in meshing engagementwith a set, or rack, of drive teeth on the displacement member. A sensorelement may be operably coupled to a gear assembly such that a singlerevolution of the position sensor 472 element corresponds to some linearlongitudinal translation of the displacement member. An arrangement ofgearing and sensors can be connected to the linear actuator, via a rackand pinion arrangement, or a rotary actuator, via a spur gear or otherconnection. A power source supplies power to the absolute positioningsystem and an output indicator may display the output of the absolutepositioning system. The displacement member represents thelongitudinally movable drive member comprising a rack of drive teethformed thereon for meshing engagement with a corresponding drive gear ofthe gear reducer assembly. The displacement member represents thelongitudinally movable firing member, firing bar, I-beam, orcombinations thereof.

A single revolution of the sensor element associated with the positionsensor 472 is equivalent to a longitudinal linear displacement d1 of theof the displacement member, where d1 is the longitudinal linear distancethat the displacement member moves from point “a” to point “b” after asingle revolution of the sensor element coupled to the displacementmember. The sensor arrangement may be connected via a gear reductionthat results in the position sensor 472 completing one or morerevolutions for the full stroke of the displacement member. The positionsensor 472 may complete multiple revolutions for the full stroke of thedisplacement member.

A series of switches, where n is an integer greater than one, may beemployed alone or in combination with a gear reduction to provide aunique position signal for more than one revolution of the positionsensor 472. The state of the switches are fed back to themicrocontroller 461 that applies logic to determine a unique positionsignal corresponding to the longitudinal linear displacement d1+d2+ . .. dn of the displacement member. The output of the position sensor 472is provided to the microcontroller 461. The position sensor 472 of thesensor arrangement may comprise a magnetic sensor, an analog rotarysensor like a potentiometer, or an array of analog Hall-effect elements,which output a unique combination of position signals or values.

The position sensor 472 may comprise any number of magnetic sensingelements, such as, for example, magnetic sensors classified according towhether they measure the total magnetic field or the vector componentsof the magnetic field. The techniques used to produce both types ofmagnetic sensors encompass many aspects of physics and electronics. Thetechnologies used for magnetic field sensing include search coil,fluxgate, optically pumped, nuclear precession, SQUID, Hall-effect,anisotropic magnetoresistance, giant magnetoresistance, magnetic tunneljunctions, giant magnetoimpedance, magnetostrictive/piezoelectriccomposites, magnetodiode, magnetotransistor, fiber-optic, magneto-optic,and microelectromechanical systems-based magnetic sensors, among others.

In one aspect, the position sensor 472 for the tracking system 480comprising an absolute positioning system comprises a magnetic rotaryabsolute positioning system. The position sensor 472 may be implementedas an AS5055EQFT single-chip magnetic rotary position sensor availablefrom Austria Microsystems, AG. The position sensor 472 is interfacedwith the microcontroller 461 to provide an absolute positioning system.The position sensor 472 is a low-voltage and low-power component andincludes four Hall-effect elements in an area of the position sensor 472that is located above a magnet. A high-resolution ADC and a smart powermanagement controller are also provided on the chip. A coordinaterotation digital computer (CORDIC) processor, also known as thedigit-by-digit method and Volder's algorithm, is provided to implement asimple and efficient algorithm to calculate hyperbolic and trigonometricfunctions that require only addition, subtraction, bitshift, and tablelookup operations. The angle position, alarm bits, and magnetic fieldinformation are transmitted over a standard serial communicationinterface, such as a serial peripheral interface (SPI) interface, to themicrocontroller 461. The position sensor 472 provides 12 or 14 bits ofresolution. The position sensor 472 may be an AS5055 chip provided in asmall QFN 16-pin 4×4×0.85 mm package.

The tracking system 480 comprising an absolute positioning system maycomprise and/or be programmed to implement a feedback controller, suchas a PID, state feedback, and adaptive controller. A power sourceconverts the signal from the feedback controller into a physical inputto the system: in this case the voltage. Other examples include a PWM ofthe voltage, current, and force. Other sensor(s) may be provided tomeasure physical parameters of the physical system in addition to theposition measured by the position sensor 472. In some aspects, the othersensor(s) can include sensor arrangements such as those described inU.S. Pat. No. 9,345,481, titled STAPLE CARTRIDGE TISSUE THICKNESS SENSORSYSTEM, which issued on May 24, 2016, which is herein incorporated byreference in its entirety; U.S. Patent Application Publication No.2014/0263552, titled STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM,which published on Sep. 18, 2014, which is herein incorporated byreference in its entirety; and U.S. patent application Ser. No.15/628,175, titled TECHNIQUES FOR ADAPTIVE CONTROL OF MOTOR VELOCITY OFA SURGICAL STAPLING AND CUTTING INSTRUMENT, filed Jun. 20, 2017, whichis herein incorporated by reference in its entirety. In a digital signalprocessing system, an absolute positioning system is coupled to adigital data acquisition system where the output of the absolutepositioning system will have a finite resolution and sampling frequency.The absolute positioning system may comprise a compare-and-combinecircuit to combine a computed response with a measured response usingalgorithms, such as a weighted average and a theoretical control loop,that drive the computed response towards the measured response. Thecomputed response of the physical system takes into account propertieslike mass, inertial, viscous friction, inductance resistance, etc., topredict what the states and outputs of the physical system will be byknowing the input.

The absolute positioning system provides an absolute position of thedisplacement member upon power-up of the instrument, without retractingor advancing the displacement member to a reset (zero or home) positionas may be required with conventional rotary encoders that merely countthe number of steps forwards or backwards that the motor 482 has takento infer the position of a device actuator, drive bar, knife, or thelike.

A sensor 474, such as, for example, a strain gauge or a micro-straingauge, is configured to measure one or more parameters of the endeffector, such as, for example, the amplitude of the strain exerted onthe anvil during a clamping operation, which can be indicative of theclosure forces applied to the anvil. The measured strain is converted toa digital signal and provided to the processor 462. Alternatively, or inaddition to the sensor 474, a sensor 476, such as, for example, a loadsensor, can measure the closure force applied by the closure drivesystem to the anvil. The sensor 476, such as, for example, a loadsensor, can measure the firing force applied to an I-beam in a firingstroke of the surgical instrument or tool. The I-beam is configured toengage a wedge sled, which is configured to upwardly cam staple driversto force out staples into deforming contact with an anvil. The I-beamalso includes a sharpened cutting edge that can be used to sever tissueas the I-beam is advanced distally by the firing bar. Alternatively, acurrent sensor 478 can be employed to measure the current drawn by themotor 482. The force required to advance the firing member cancorrespond to the current drawn by the motor 482, for example. Themeasured force is converted to a digital signal and provided to theprocessor 462.

In one form, the strain gauge sensor 474 can be used to measure theforce applied to the tissue by the end effector. A strain gauge can becoupled to the end effector to measure the force on the tissue beingtreated by the end effector. A system for measuring forces applied tothe tissue grasped by the end effector comprises a strain gauge sensor474, such as, for example, a micro-strain gauge, that is configured tomeasure one or more parameters of the end effector, for example. In oneaspect, the strain gauge sensor 474 can measure the amplitude ormagnitude of the strain exerted on a jaw member of an end effectorduring a clamping operation, which can be indicative of the tissuecompression. The measured strain is converted to a digital signal andprovided to a processor 462 of the microcontroller 461. A load sensor476 can measure the force used to operate the knife element, forexample, to cut the tissue captured between the anvil and the staplecartridge. A magnetic field sensor can be employed to measure thethickness of the captured tissue. The measurement of the magnetic fieldsensor also may be converted to a digital signal and provided to theprocessor 462.

The measurements of the tissue compression, the tissue thickness, and/orthe force required to close the end effector on the tissue, asrespectively measured by the sensors 474, 476, can be used by themicrocontroller 461 to characterize the selected position of the firingmember and/or the corresponding value of the speed of the firing member.In one instance, a memory 468 may store a technique, an equation, and/ora lookup table which can be employed by the microcontroller 461 in theassessment.

The control system 470 of the surgical instrument or tool also maycomprise wired or wireless communication circuits to communicate withthe modular communication hub as shown in FIGS. 8-11.

FIG. 13 illustrates a control circuit 500 configured to control aspectsof the surgical instrument or tool according to one aspect of thisdisclosure. The control circuit 500 can be configured to implementvarious processes described herein. The control circuit 500 may comprisea microcontroller comprising one or more processors 502 (e.g.,microprocessor, microcontroller) coupled to at least one memory circuit504. The memory circuit 504 stores machine-executable instructions that,when executed by the processor 502, cause the processor 502 to executemachine instructions to implement various processes described herein.The processor 502 may be any one of a number of single-core or multicoreprocessors known in the art. The memory circuit 504 may comprisevolatile and non-volatile storage media. The processor 502 may includean instruction processing unit 506 and an arithmetic unit 508. Theinstruction processing unit may be configured to receive instructionsfrom the memory circuit 504 of this disclosure.

FIG. 14 illustrates a combinational logic circuit 510 configured tocontrol aspects of the surgical instrument or tool according to oneaspect of this disclosure. The combinational logic circuit 510 can beconfigured to implement various processes described herein. Thecombinational logic circuit 510 may comprise a finite state machinecomprising a combinational logic 512 configured to receive dataassociated with the surgical instrument or tool at an input 514, processthe data by the combinational logic 512, and provide an output 516.

FIG. 15 illustrates a sequential logic circuit 520 configured to controlaspects of the surgical instrument or tool according to one aspect ofthis disclosure. The sequential logic circuit 520 or the combinationallogic 522 can be configured to implement various processes describedherein. The sequential logic circuit 520 may comprise a finite statemachine. The sequential logic circuit 520 may comprise a combinationallogic 522, at least one memory circuit 524, and a clock 529, forexample. The at least one memory circuit 524 can store a current stateof the finite state machine. In certain instances, the sequential logiccircuit 520 may be synchronous or asynchronous. The combinational logic522 is configured to receive data associated with the surgicalinstrument or tool from an input 526, process the data by thecombinational logic 522, and provide an output 528. In other aspects,the circuit may comprise a combination of a processor (e.g., processor502, FIG. 13) and a finite state machine to implement various processesherein. In other aspects, the finite state machine may comprise acombination of a combinational logic circuit (e.g., combinational logiccircuit 510, FIG. 14) and the sequential logic circuit 520.

FIG. 16 illustrates a surgical instrument or tool comprising a pluralityof motors which can be activated to perform various functions. Incertain instances, a first motor can be activated to perform a firstfunction, a second motor can be activated to perform a second function,a third motor can be activated to perform a third function, a fourthmotor can be activated to perform a fourth function, and so on. Incertain instances, the plurality of motors of robotic surgicalinstrument 600 can be individually activated to cause firing, closure,and/or articulation motions in the end effector. The firing, closure,and/or articulation motions can be transmitted to the end effectorthrough a shaft assembly, for example.

In certain instances, the surgical instrument system or tool may includea firing motor 602. The firing motor 602 may be operably coupled to afiring motor drive assembly 604 which can be configured to transmitfiring motions, generated by the motor 602 to the end effector, inparticular to displace the I-beam element. In certain instances, thefiring motions generated by the motor 602 may cause the staples to bedeployed from the staple cartridge into tissue captured by the endeffector and/or the cutting edge of the I-beam element to be advanced tocut the captured tissue, for example. The I-beam element may beretracted by reversing the direction of the motor 602.

In certain instances, the surgical instrument or tool may include aclosure motor 603. The closure motor 603 may be operably coupled to aclosure motor drive assembly 605 which can be configured to transmitclosure motions, generated by the motor 603 to the end effector, inparticular to displace a closure tube to close the anvil and compresstissue between the anvil and the staple cartridge. The closure motionsmay cause the end effector to transition from an open configuration toan approximated configuration to capture tissue, for example. The endeffector may be transitioned to an open position by reversing thedirection of the motor 603.

In certain instances, the surgical instrument or tool may include one ormore articulation motors 606 a, 606 b, for example. The motors 606 a,606 b may be operably coupled to respective articulation motor driveassemblies 608 a, 608 b, which can be configured to transmitarticulation motions generated by the motors 606 a, 606 b to the endeffector. In certain instances, the articulation motions may cause theend effector to articulate relative to the shaft, for example.

As described above, the surgical instrument or tool may include aplurality of motors which may be configured to perform variousindependent functions. In certain instances, the plurality of motors ofthe surgical instrument or tool can be individually or separatelyactivated to perform one or more functions while the other motors remaininactive. For example, the articulation motors 606 a, 606 b can beactivated to cause the end effector to be articulated while the firingmotor 602 remains inactive. Alternatively, the firing motor 602 can beactivated to fire the plurality of staples, and/or to advance thecutting edge, while the articulation motor 606 remains inactive.Furthermore, the closure motor 603 may be activated simultaneously withthe firing motor 602 to cause the closure tube and the I-beam element toadvance distally as described in more detail hereinbelow.

In certain instances, the surgical instrument or tool may include acommon control module 610 which can be employed with a plurality ofmotors of the surgical instrument or tool. In certain instances, thecommon control module 610 may accommodate one of the plurality of motorsat a time. For example, the common control module 610 can be couplableto and separable from the plurality of motors of the robotic surgicalinstrument individually. In certain instances, a plurality of the motorsof the surgical instrument or tool may share one or more common controlmodules such as the common control module 610. In certain instances, aplurality of motors of the surgical instrument or tool can beindividually and selectively engaged with the common control module 610.In certain instances, the common control module 610 can be selectivelyswitched from interfacing with one of a plurality of motors of thesurgical instrument or tool to interfacing with another one of theplurality of motors of the surgical instrument or tool.

In at least one example, the common control module 610 can beselectively switched between operable engagement with the articulationmotors 606 a, 606 b and operable engagement with either the firing motor602 or the closure motor 603. In at least one example, as illustrated inFIG. 16, a switch 614 can be moved or transitioned between a pluralityof positions and/or states. In a first position 616, the switch 614 mayelectrically couple the common control module 610 to the firing motor602; in a second position 617, the switch 614 may electrically couplethe common control module 610 to the closure motor 603; in a thirdposition 618 a, the switch 614 may electrically couple the commoncontrol module 610 to the first articulation motor 606 a; and in afourth position 618 b, the switch 614 may electrically couple the commoncontrol module 610 to the second articulation motor 606 b, for example.In certain instances, separate common control modules 610 can beelectrically coupled to the firing motor 602, the closure motor 603, andthe articulations motor 606 a, 606 b at the same time. In certaininstances, the switch 614 may be a mechanical switch, anelectromechanical switch, a solid-state switch, or any suitableswitching mechanism.

Each of the motors 602, 603, 606 a, 606 b may comprise a torque sensorto measure the output torque on the shaft of the motor. The force on anend effector may be sensed in any conventional manner, such as by forcesensors on the outer sides of the jaws or by a torque sensor for themotor actuating the jaws.

In various instances, as illustrated in FIG. 16, the common controlmodule 610 may comprise a motor driver 626 which may comprise one ormore H-Bridge FETs. The motor driver 626 may modulate the powertransmitted from a power source 628 to a motor coupled to the commoncontrol module 610 based on input from a microcontroller 620 (the“controller”), for example. In certain instances, the microcontroller620 can be employed to determine the current drawn by the motor, forexample, while the motor is coupled to the common control module 610, asdescribed above.

In certain instances, the microcontroller 620 may include amicroprocessor 622 (the “processor”) and one or more non-transitorycomputer-readable mediums or memory units 624 (the “memory”). In certaininstances, the memory 624 may store various program instructions, whichwhen executed may cause the processor 622 to perform a plurality offunctions and/or calculations described herein. In certain instances,one or more of the memory units 624 may be coupled to the processor 622,for example.

In certain instances, the power source 628 can be employed to supplypower to the microcontroller 620, for example. In certain instances, thepower source 628 may comprise a battery (or “battery pack” or “powerpack”), such as a lithium-ion battery, for example. In certaininstances, the battery pack may be configured to be releasably mountedto a handle for supplying power to the surgical instrument 600. A numberof battery cells connected in series may be used as the power source628. In certain instances, the power source 628 may be replaceableand/or rechargeable, for example.

In various instances, the processor 622 may control the motor driver 626to control the position, direction of rotation, and/or velocity of amotor that is coupled to the common control module 610. In certaininstances, the processor 622 can signal the motor driver 626 to stopand/or disable a motor that is coupled to the common control module 610.It should be understood that the term “processor” as used hereinincludes any suitable microprocessor, microcontroller, or other basiccomputing device that incorporates the functions of a computer's centralprocessing unit (CPU) on an integrated circuit or, at most, a fewintegrated circuits. The processor is a multipurpose, programmabledevice that accepts digital data as input, processes it according toinstructions stored in its memory, and provides results as output. It isan example of sequential digital logic, as it has internal memory.Processors operate on numbers and symbols represented in the binarynumeral system.

In one instance, the processor 622 may be any single-core or multicoreprocessor such as those known under the trade name ARM Cortex by TexasInstruments. In certain instances, the microcontroller 620 may be an LM4F230H5QR, available from Texas Instruments, for example. In at leastone example, the Texas Instruments LM4F230H5QR is an ARM Cortex-M4FProcessor Core comprising an on-chip memory of 256 KB single-cycle flashmemory, or other non-volatile memory, up to 40 MHz, a prefetch buffer toimprove performance above 40 MHz, a 32 KB single-cycle SRAM, an internalROM loaded with StellarisWare® software, a 2 KB EEPROM, one or more PWMmodules, one or more QEI analogs, one or more 12-bit ADCs with 12 analoginput channels, among other features that are readily available for theproduct datasheet. Other microcontrollers may be readily substituted foruse with the module 4410. Accordingly, the present disclosure should notbe limited in this context.

In certain instances, the memory 624 may include program instructionsfor controlling each of the motors of the surgical instrument 600 thatare couplable to the common control module 610. For example, the memory624 may include program instructions for controlling the firing motor602, the closure motor 603, and the articulation motors 606 a, 606 b.Such program instructions may cause the processor 622 to control thefiring, closure, and articulation functions in accordance with inputsfrom algorithms or control programs of the surgical instrument or tool.

In certain instances, one or more mechanisms and/or sensors such as, forexample, sensors 630 can be employed to alert the processor 622 to theprogram instructions that should be used in a particular setting. Forexample, the sensors 630 may alert the processor 622 to use the programinstructions associated with firing, closing, and articulating the endeffector. In certain instances, the sensors 630 may comprise positionsensors which can be employed to sense the position of the switch 614,for example. Accordingly, the processor 622 may use the programinstructions associated with firing the I-beam of the end effector upondetecting, through the sensors 630 for example, that the switch 614 isin the first position 616; the processor 622 may use the programinstructions associated with closing the anvil upon detecting, throughthe sensors 630 for example, that the switch 614 is in the secondposition 617; and the processor 622 may use the program instructionsassociated with articulating the end effector upon detecting, throughthe sensors 630 for example, that the switch 614 is in the third orfourth position 618 a, 618 b.

FIG. 17 is a schematic diagram of a robotic surgical instrument 700configured to operate a surgical tool described herein according to oneaspect of this disclosure. The robotic surgical instrument 700 may beprogrammed or configured to control distal/proximal translation of adisplacement member, distal/proximal displacement of a closure tube,shaft rotation, and articulation, either with single or multiplearticulation drive links. In one aspect, the surgical instrument 700 maybe programmed or configured to individually control a firing member, aclosure member, a shaft member, and/or one or more articulation members.The surgical instrument 700 comprises a control circuit 710 configuredto control motor-driven firing members, closure members, shaft members,and/or one or more articulation members.

In one aspect, the robotic surgical instrument 700 comprises a controlcircuit 710 configured to control an anvil 716 and an I-beam 714(including a sharp cutting edge) portion of an end effector 702, aremovable staple cartridge 718, a shaft 740, and one or morearticulation members 742 a, 742 b via a plurality of motors 704 a-704 e.A position sensor 734 may be configured to provide position feedback ofthe I-beam 714 to the control circuit 710. Other sensors 738 may beconfigured to provide feedback to the control circuit 710. Atimer/counter 731 provides timing and counting information to thecontrol circuit 710. An energy source 712 may be provided to operate themotors 704 a-704 e, and a current sensor 736 provides motor currentfeedback to the control circuit 710. The motors 704 a-704 e can beoperated individually by the control circuit 710 in an open-loop orclosed-loop feedback control.

In one aspect, the control circuit 710 may comprise one or moremicrocontrollers, microprocessors, or other suitable processors forexecuting instructions that cause the processor or processors to performone or more tasks. In one aspect, a timer/counter 731 provides an outputsignal, such as the elapsed time or a digital count, to the controlcircuit 710 to correlate the position of the I-beam 714 as determined bythe position sensor 734 with the output of the timer/counter 731 suchthat the control circuit 710 can determine the position of the I-beam714 at a specific time (t) relative to a starting position or the time(t) when the I-beam 714 is at a specific position relative to a startingposition. The timer/counter 731 may be configured to measure elapsedtime, count external events, or time external events.

In one aspect, the control circuit 710 may be programmed to controlfunctions of the end effector 702 based on one or more tissueconditions. The control circuit 710 may be programmed to sense tissueconditions, such as thickness, either directly or indirectly, asdescribed herein. The control circuit 710 may be programmed to select afiring control program or closure control program based on tissueconditions. A firing control program may describe the distal motion ofthe displacement member. Different firing control programs may beselected to better treat different tissue conditions. For example, whenthicker tissue is present, the control circuit 710 may be programmed totranslate the displacement member at a lower velocity and/or with lowerpower. When thinner tissue is present, the control circuit 710 may beprogrammed to translate the displacement member at a higher velocityand/or with higher power. A closure control program may control theclosure force applied to the tissue by the anvil 716. Other controlprograms control the rotation of the shaft 740 and the articulationmembers 742 a, 742 b.

In one aspect, the control circuit 710 may generate motor set pointsignals. The motor set point signals may be provided to various motorcontrollers 708 a-708 e. The motor controllers 708 a-708 e may compriseone or more circuits configured to provide motor drive signals to themotors 704 a-704 e to drive the motors 704 a-704 e as described herein.In some examples, the motors 704 a-704 e may be brushed DC electricmotors. For example, the velocity of the motors 704 a-704 e may beproportional to the respective motor drive signals. In some examples,the motors 704 a-704 e may be brushless DC electric motors, and therespective motor drive signals may comprise a PWM signal provided to oneor more stator windings of the motors 704 a-704 e. Also, in someexamples, the motor controllers 708 a-708 e may be omitted and thecontrol circuit 710 may generate the motor drive signals directly.

In one aspect, the control circuit 710 may initially operate each of themotors 704 a-704 e in an open-loop configuration for a first open-loopportion of a stroke of the displacement member. Based on the response ofthe robotic surgical instrument 700 during the open-loop portion of thestroke, the control circuit 710 may select a firing control program in aclosed-loop configuration. The response of the instrument may include atranslation distance of the displacement member during the open-loopportion, a time elapsed during the open-loop portion, the energyprovided to one of the motors 704 a-704 e during the open-loop portion,a sum of pulse widths of a motor drive signal, etc. After the open-loopportion, the control circuit 710 may implement the selected firingcontrol program for a second portion of the displacement member stroke.For example, during a closed-loop portion of the stroke, the controlcircuit 710 may modulate one of the motors 704 a-704 e based ontranslation data describing a position of the displacement member in aclosed-loop manner to translate the displacement member at a constantvelocity.

In one aspect, the motors 704 a-704 e may receive power from an energysource 712. The energy source 712 may be a DC power supply driven by amain alternating current power source, a battery, a super capacitor, orany other suitable energy source. The motors 704 a-704 e may bemechanically coupled to individual movable mechanical elements such asthe I-beam 714, anvil 716, shaft 740, articulation 742 a, andarticulation 742 b via respective transmissions 706 a-706 e. Thetransmissions 706 a-706 e may include one or more gears or other linkagecomponents to couple the motors 704 a-704 e to movable mechanicalelements. A position sensor 734 may sense a position of the I-beam 714.The position sensor 734 may be or include any type of sensor that iscapable of generating position data that indicate a position of theI-beam 714. In some examples, the position sensor 734 may include anencoder configured to provide a series of pulses to the control circuit710 as the I-beam 714 translates distally and proximally. The controlcircuit 710 may track the pulses to determine the position of the I-beam714. Other suitable position sensors may be used, including, forexample, a proximity sensor. Other types of position sensors may provideother signals indicating motion of the I-beam 714. Also, in someexamples, the position sensor 734 may be omitted. Where any of themotors 704 a-704 e is a stepper motor, the control circuit 710 may trackthe position of the I-beam 714 by aggregating the number and directionof steps that the motor 704 has been instructed to execute. The positionsensor 734 may be located in the end effector 702 or at any otherportion of the instrument. The outputs of each of the motors 704 a-704 einclude a torque sensor 744 a-744 e to sense force and have an encoderto sense rotation of the drive shaft.

In one aspect, the control circuit 710 is configured to drive a firingmember such as the I-beam 714 portion of the end effector 702. Thecontrol circuit 710 provides a motor set point to a motor control 708 a,which provides a drive signal to the motor 704 a. The output shaft ofthe motor 704 a is coupled to a torque sensor 744 a. The torque sensor744 a is coupled to a transmission 706 a which is coupled to the I-beam714. The transmission 706 a comprises movable mechanical elements suchas rotating elements and a firing member to control the movement of theI-beam 714 distally and proximally along a longitudinal axis of the endeffector 702. In one aspect, the motor 704 a may be coupled to the knifegear assembly, which includes a knife gear reduction set that includes afirst knife drive gear and a second knife drive gear. A torque sensor744 a provides a firing force feedback signal to the control circuit710. The firing force signal represents the force required to fire ordisplace the I-beam 714. A position sensor 734 may be configured toprovide the position of the I-beam 714 along the firing stroke or theposition of the firing member as a feedback signal to the controlcircuit 710. The end effector 702 may include additional sensors 738configured to provide feedback signals to the control circuit 710. Whenready to use, the control circuit 710 may provide a firing signal to themotor control 708 a. In response to the firing signal, the motor 704 amay drive the firing member distally along the longitudinal axis of theend effector 702 from a proximal stroke start position to a stroke endposition distal to the stroke start position. As the firing membertranslates distally, an I-beam 714, with a cutting element positioned ata distal end, advances distally to cut tissue located between the staplecartridge 718 and the anvil 716.

In one aspect, the control circuit 710 is configured to drive a closuremember such as the anvil 716 portion of the end effector 702. Thecontrol circuit 710 provides a motor set point to a motor control 708 b,which provides a drive signal to the motor 704 b. The output shaft ofthe motor 704 b is coupled to a torque sensor 744 b. The torque sensor744 b is coupled to a transmission 706 b which is coupled to the anvil716. The transmission 706 b comprises movable mechanical elements suchas rotating elements and a closure member to control the movement of theanvil 716 from the open and closed positions. In one aspect, the motor704 b is coupled to a closure gear assembly, which includes a closurereduction gear set that is supported in meshing engagement with theclosure spur gear. The torque sensor 744 b provides a closure forcefeedback signal to the control circuit 710. The closure force feedbacksignal represents the closure force applied to the anvil 716. Theposition sensor 734 may be configured to provide the position of theclosure member as a feedback signal to the control circuit 710.Additional sensors 738 in the end effector 702 may provide the closureforce feedback signal to the control circuit 710. The pivotable anvil716 is positioned opposite the staple cartridge 718. When ready to use,the control circuit 710 may provide a closure signal to the motorcontrol 708 b. In response to the closure signal, the motor 704 badvances a closure member to grasp tissue between the anvil 716 and thestaple cartridge 718.

In one aspect, the control circuit 710 is configured to rotate a shaftmember such as the shaft 740 to rotate the end effector 702. The controlcircuit 710 provides a motor set point to a motor control 708 c, whichprovides a drive signal to the motor 704 c. The output shaft of themotor 704 c is coupled to a torque sensor 744 c. The torque sensor 744 cis coupled to a transmission 706 c which is coupled to the shaft 740.The transmission 706 c comprises movable mechanical elements such asrotating elements to control the rotation of the shaft 740 clockwise orcounterclockwise up to and over 360°. In one aspect, the motor 704 c iscoupled to the rotational transmission assembly, which includes a tubegear segment that is formed on (or attached to) the proximal end of theproximal closure tube for operable engagement by a rotational gearassembly that is operably supported on the tool mounting plate. Thetorque sensor 744 c provides a rotation force feedback signal to thecontrol circuit 710. The rotation force feedback signal represents therotation force applied to the shaft 740. The position sensor 734 may beconfigured to provide the position of the closure member as a feedbacksignal to the control circuit 710. Additional sensors 738 such as ashaft encoder may provide the rotational position of the shaft 740 tothe control circuit 710.

In one aspect, the control circuit 710 is configured to articulate theend effector 702. The control circuit 710 provides a motor set point toa motor control 708 d, which provides a drive signal to the motor 704 d.The output shaft of the motor 704 d is coupled to a torque sensor 744 d.The torque sensor 744 d is coupled to a transmission 706 d which iscoupled to an articulation member 742 a. The transmission 706 dcomprises movable mechanical elements such as articulation elements tocontrol the articulation of the end effector 702 ±65°. In one aspect,the motor 704 d is coupled to an articulation nut, which is rotatablyjournaled on the proximal end portion of the distal spine portion and isrotatably driven thereon by an articulation gear assembly. The torquesensor 744 d provides an articulation force feedback signal to thecontrol circuit 710. The articulation force feedback signal representsthe articulation force applied to the end effector 702. Sensors 738,such as an articulation encoder, may provide the articulation positionof the end effector 702 to the control circuit 710.

In another aspect, the articulation function of the robotic surgicalsystem 700 may comprise two articulation members, or links, 742 a, 742b. These articulation members 742 a, 742 b are driven by separate diskson the robot interface (the rack) which are driven by the two motors 708d, 708 e. When the separate firing motor 704 a is provided, each ofarticulation links 742 a, 742 b can be antagonistically driven withrespect to the other link in order to provide a resistive holding motionand a load to the head when it is not moving and to provide anarticulation motion as the head is articulated. The articulation members742 a, 742 b attach to the head at a fixed radius as the head isrotated. Accordingly, the mechanical advantage of the push-and-pull linkchanges as the head is rotated. This change in the mechanical advantagemay be more pronounced with other articulation link drive systems.

In one aspect, the one or more motors 704 a-704 e may comprise a brushedDC motor with a gearbox and mechanical links to a firing member, closuremember, or articulation member. Another example includes electric motors704 a-704 e that operate the movable mechanical elements such as thedisplacement member, articulation links, closure tube, and shaft. Anoutside influence is an unmeasured, unpredictable influence of thingslike tissue, surrounding bodies, and friction on the physical system.Such outside influence can be referred to as drag, which acts inopposition to one of electric motors 704 a-704 e. The outside influence,such as drag, may cause the operation of the physical system to deviatefrom a desired operation of the physical system.

In one aspect, the position sensor 734 may be implemented as an absolutepositioning system. In one aspect, the position sensor 734 may comprisea magnetic rotary absolute positioning system implemented as anAS5055EQFT single-chip magnetic rotary position sensor available fromAustria Microsystems, AG. The position sensor 734 may interface with thecontrol circuit 710 to provide an absolute positioning system. Theposition may include multiple Hall-effect elements located above amagnet and coupled to a CORDIC processor, also known as thedigit-by-digit method and Volder's algorithm, that is provided toimplement a simple and efficient algorithm to calculate hyperbolic andtrigonometric functions that require only addition, subtraction,bitshift, and table lookup operations.

In one aspect, the control circuit 710 may be in communication with oneor more sensors 738. The sensors 738 may be positioned on the endeffector 702 and adapted to operate with the robotic surgical instrument700 to measure the various derived parameters such as the gap distanceversus time, tissue compression versus time, and anvil strain versustime. The sensors 738 may comprise a magnetic sensor, a magnetic fieldsensor, a strain gauge, a load cell, a pressure sensor, a force sensor,a torque sensor, an inductive sensor such as an eddy current sensor, aresistive sensor, a capacitive sensor, an optical sensor, and/or anyother suitable sensor for measuring one or more parameters of the endeffector 702. The sensors 738 may include one or more sensors. Thesensors 738 may be located on the staple cartridge 718 deck to determinetissue location using segmented electrodes. The torque sensors 744 a-744e may be configured to sense force such as firing force, closure force,and/or articulation force, among others. Accordingly, the controlcircuit 710 can sense (1) the closure load experienced by the distalclosure tube and its position, (2) the firing member at the rack and itsposition, (3) what portion of the staple cartridge 718 has tissue on it,and (4) the load and position on both articulation rods.

In one aspect, the one or more sensors 738 may comprise a strain gauge,such as a micro-strain gauge, configured to measure the magnitude of thestrain in the anvil 716 during a clamped condition. The strain gaugeprovides an electrical signal whose amplitude varies with the magnitudeof the strain. The sensors 738 may comprise a pressure sensor configuredto detect a pressure generated by the presence of compressed tissuebetween the anvil 716 and the staple cartridge 718. The sensors 738 maybe configured to detect impedance of a tissue section located betweenthe anvil 716 and the staple cartridge 718 that is indicative of thethickness and/or fullness of tissue located therebetween.

In one aspect, the sensors 738 may be implemented as one or more limitswitches, electromechanical devices, solid-state switches, Hall-effectdevices, magneto-resistive (MR) devices, giant magneto-resistive (GMR)devices, magnetometers, among others. In other implementations, thesensors 738 may be implemented as solid-state switches that operateunder the influence of light, such as optical sensors, IR sensors,ultraviolet sensors, among others. Still, the switches may besolid-state devices such as transistors (e.g., FET, junction FET,MOSFET, bipolar, and the like). In other implementations, the sensors738 may include electrical conductorless switches, ultrasonic switches,accelerometers, and inertial sensors, among others.

In one aspect, the sensors 738 may be configured to measure forcesexerted on the anvil 716 by the closure drive system. For example, oneor more sensors 738 can be at an interaction point between the closuretube and the anvil 716 to detect the closure forces applied by theclosure tube to the anvil 716. The forces exerted on the anvil 716 canbe representative of the tissue compression experienced by the tissuesection captured between the anvil 716 and the staple cartridge 718. Theone or more sensors 738 can be positioned at various interaction pointsalong the closure drive system to detect the closure forces applied tothe anvil 716 by the closure drive system. The one or more sensors 738may be sampled in real time during a clamping operation by the processorof the control circuit 710. The control circuit 710 receives real-timesample measurements to provide and analyze time-based information andassess, in real time, closure forces applied to the anvil 716.

In one aspect, a current sensor 736 can be employed to measure thecurrent drawn by each of the motors 704 a-704 e. The force required toadvance any of the movable mechanical elements such as the I-beam 714corresponds to the current drawn by one of the motors 704 a-704 e. Theforce is converted to a digital signal and provided to the controlcircuit 710. The control circuit 710 can be configured to simulate theresponse of the actual system of the instrument in the software of thecontroller. A displacement member can be actuated to move an I-beam 714in the end effector 702 at or near a target velocity. The roboticsurgical instrument 700 can include a feedback controller, which can beone of any feedback controllers, including, but not limited to a PID, astate feedback, a linear-quadratic (LQR), and/or an adaptive controller,for example. The robotic surgical instrument 700 can include a powersource to convert the signal from the feedback controller into aphysical input such as case voltage, PWM voltage, frequency modulatedvoltage, current, torque, and/or force, for example. Additional detailsare disclosed in U.S. patent application Ser. No. 15/636,829, titledCLOSED LOOP VELOCITY CONTROL TECHNIQUES FOR ROBOTIC SURGICAL INSTRUMENT,filed Jun. 29, 2017, which is herein incorporated by reference in itsentirety.

FIG. 18 illustrates a block diagram of a surgical instrument 750programmed to control the distal translation of a displacement memberaccording to one aspect of this disclosure. In one aspect, the surgicalinstrument 750 is programmed to control the distal translation of adisplacement member such as the I-beam 764. The surgical instrument 750comprises an end effector 752 that may comprise an anvil 766, an I-beam764 (including a sharp cutting edge), and a removable staple cartridge768.

The position, movement, displacement, and/or translation of a lineardisplacement member, such as the I-beam 764, can be measured by anabsolute positioning system, sensor arrangement, and position sensor784. Because the I-beam 764 is coupled to a longitudinally movable drivemember, the position of the I-beam 764 can be determined by measuringthe position of the longitudinally movable drive member employing theposition sensor 784. Accordingly, in the following description, theposition, displacement, and/or translation of the I-beam 764 can beachieved by the position sensor 784 as described herein. A controlcircuit 760 may be programmed to control the translation of thedisplacement member, such as the I-beam 764. The control circuit 760, insome examples, may comprise one or more microcontrollers,microprocessors, or other suitable processors for executing instructionsthat cause the processor or processors to control the displacementmember, e.g., the I-beam 764, in the manner described. In one aspect, atimer/counter 781 provides an output signal, such as the elapsed time ora digital count, to the control circuit 760 to correlate the position ofthe I-beam 764 as determined by the position sensor 784 with the outputof the timer/counter 781 such that the control circuit 760 can determinethe position of the I-beam 764 at a specific time (t) relative to astarting position. The timer/counter 781 may be configured to measureelapsed time, count external events, or time external events.

The control circuit 760 may generate a motor set point signal 772. Themotor set point signal 772 may be provided to a motor controller 758.The motor controller 758 may comprise one or more circuits configured toprovide a motor drive signal 774 to the motor 754 to drive the motor 754as described herein. In some examples, the motor 754 may be a brushed DCelectric motor. For example, the velocity of the motor 754 may beproportional to the motor drive signal 774. In some examples, the motor754 may be a brushless DC electric motor and the motor drive signal 774may comprise a PWM signal provided to one or more stator windings of themotor 754. Also, in some examples, the motor controller 758 may beomitted, and the control circuit 760 may generate the motor drive signal774 directly.

The motor 754 may receive power from an energy source 762. The energysource 762 may be or include a battery, a super capacitor, or any othersuitable energy source. The motor 754 may be mechanically coupled to theI-beam 764 via a transmission 756. The transmission 756 may include oneor more gears or other linkage components to couple the motor 754 to theI-beam 764. A position sensor 784 may sense a position of the I-beam764. The position sensor 784 may be or include any type of sensor thatis capable of generating position data that indicate a position of theI-beam 764. In some examples, the position sensor 784 may include anencoder configured to provide a series of pulses to the control circuit760 as the I-beam 764 translates distally and proximally. The controlcircuit 760 may track the pulses to determine the position of the I-beam764. Other suitable position sensors may be used, including, forexample, a proximity sensor. Other types of position sensors may provideother signals indicating motion of the I-beam 764. Also, in someexamples, the position sensor 784 may be omitted. Where the motor 754 isa stepper motor, the control circuit 760 may track the position of theI-beam 764 by aggregating the number and direction of steps that themotor 754 has been instructed to execute. The position sensor 784 may belocated in the end effector 752 or at any other portion of theinstrument.

The control circuit 760 may be in communication with one or more sensors788. The sensors 788 may be positioned on the end effector 752 andadapted to operate with the surgical instrument 750 to measure thevarious derived parameters such as gap distance versus time, tissuecompression versus time, and anvil strain versus time. The sensors 788may comprise a magnetic sensor, a magnetic field sensor, a strain gauge,a pressure sensor, a force sensor, an inductive sensor such as an eddycurrent sensor, a resistive sensor, a capacitive sensor, an opticalsensor, and/or any other suitable sensor for measuring one or moreparameters of the end effector 752. The sensors 788 may include one ormore sensors.

The one or more sensors 788 may comprise a strain gauge, such as amicro-strain gauge, configured to measure the magnitude of the strain inthe anvil 766 during a clamped condition. The strain gauge provides anelectrical signal whose amplitude varies with the magnitude of thestrain. The sensors 788 may comprise a pressure sensor configured todetect a pressure generated by the presence of compressed tissue betweenthe anvil 766 and the staple cartridge 768. The sensors 788 may beconfigured to detect impedance of a tissue section located between theanvil 766 and the staple cartridge 768 that is indicative of thethickness and/or fullness of tissue located therebetween.

The sensors 788 may be is configured to measure forces exerted on theanvil 766 by a closure drive system. For example, one or more sensors788 can be at an interaction point between a closure tube and the anvil766 to detect the closure forces applied by a closure tube to the anvil766. The forces exerted on the anvil 766 can be representative of thetissue compression experienced by the tissue section captured betweenthe anvil 766 and the staple cartridge 768. The one or more sensors 788can be positioned at various interaction points along the closure drivesystem to detect the closure forces applied to the anvil 766 by theclosure drive system. The one or more sensors 788 may be sampled in realtime during a clamping operation by a processor of the control circuit760. The control circuit 760 receives real-time sample measurements toprovide and analyze time-based information and assess, in real time,closure forces applied to the anvil 766.

A current sensor 786 can be employed to measure the current drawn by themotor 754. The force required to advance the I-beam 764 corresponds tothe current drawn by the motor 754. The force is converted to a digitalsignal and provided to the control circuit 760.

The control circuit 760 can be configured to simulate the response ofthe actual system of the instrument in the software of the controller. Adisplacement member can be actuated to move an I-beam 764 in the endeffector 752 at or near a target velocity. The surgical instrument 750can include a feedback controller, which can be one of any feedbackcontrollers, including, but not limited to a PID, a state feedback, LQR,and/or an adaptive controller, for example. The surgical instrument 750can include a power source to convert the signal from the feedbackcontroller into a physical input such as case voltage, PWM voltage,frequency modulated voltage, current, torque, and/or force, for example.

The actual drive system of the surgical instrument 750 is configured todrive the displacement member, cutting member, or I-beam 764, by abrushed DC motor with gearbox and mechanical links to an articulationand/or knife system. Another example is the electric motor 754 thatoperates the displacement member and the articulation driver, forexample, of an interchangeable shaft assembly. An outside influence isan unmeasured, unpredictable influence of things like tissue,surrounding bodies and friction on the physical system. Such outsideinfluence can be referred to as drag which acts in opposition to theelectric motor 754. The outside influence, such as drag, may cause theoperation of the physical system to deviate from a desired operation ofthe physical system.

Various example aspects are directed to a surgical instrument 750comprising an end effector 752 with motor-driven surgical stapling andcutting implements. For example, a motor 754 may drive a displacementmember distally and proximally along a longitudinal axis of the endeffector 752. The end effector 752 may comprise a pivotable anvil 766and, when configured for use, a staple cartridge 768 positioned oppositethe anvil 766. A clinician may grasp tissue between the anvil 766 andthe staple cartridge 768, as described herein. When ready to use theinstrument 750, the clinician may provide a firing signal, for exampleby depressing a trigger of the instrument 750. In response to the firingsignal, the motor 754 may drive the displacement member distally alongthe longitudinal axis of the end effector 752 from a proximal strokebegin position to a stroke end position distal of the stroke beginposition. As the displacement member translates distally, an I-beam 764with a cutting element positioned at a distal end, may cut the tissuebetween the staple cartridge 768 and the anvil 766.

In various examples, the surgical instrument 750 may comprise a controlcircuit 760 programmed to control the distal translation of thedisplacement member, such as the I-beam 764, for example, based on oneor more tissue conditions. The control circuit 760 may be programmed tosense tissue conditions, such as thickness, either directly orindirectly, as described herein. The control circuit 760 may beprogrammed to select a firing control program based on tissueconditions. A firing control program may describe the distal motion ofthe displacement member. Different firing control programs may beselected to better treat different tissue conditions. For example, whenthicker tissue is present, the control circuit 760 may be programmed totranslate the displacement member at a lower velocity and/or with lowerpower. When thinner tissue is present, the control circuit 760 may beprogrammed to translate the displacement member at a higher velocityand/or with higher power.

In some examples, the control circuit 760 may initially operate themotor 754 in an open loop configuration for a first open loop portion ofa stroke of the displacement member. Based on a response of theinstrument 750 during the open loop portion of the stroke, the controlcircuit 760 may select a firing control program. The response of theinstrument may include, a translation distance of the displacementmember during the open loop portion, a time elapsed during the open loopportion, energy provided to the motor 754 during the open loop portion,a sum of pulse widths of a motor drive signal, etc. After the open loopportion, the control circuit 760 may implement the selected firingcontrol program for a second portion of the displacement member stroke.For example, during the closed loop portion of the stroke, the controlcircuit 760 may modulate the motor 754 based on translation datadescribing a position of the displacement member in a closed loop mannerto translate the displacement member at a constant velocity. Additionaldetails are disclosed in U.S. patent application Ser. No. 15/720,852,titled SYSTEM AND METHODS FOR CONTROLLING A DISPLAY OF A SURGICALINSTRUMENT, filed Sep. 29, 2017, which is herein incorporated byreference in its entirety.

FIG. 19 is a schematic diagram of a surgical instrument 790 configuredto control various functions according to one aspect of this disclosure.In one aspect, the surgical instrument 790 is programmed to controldistal translation of a displacement member such as the I-beam 764. Thesurgical instrument 790 comprises an end effector 792 that may comprisean anvil 766, an I-beam 764, and a removable staple cartridge 768 whichmay be interchanged with an RF cartridge 796 (shown in dashed line).

In one aspect, sensors 788 may be implemented as a limit switch,electromechanical device, solid-state switches, Hall-effect devices, MRdevices, GMR devices, magnetometers, among others. In otherimplementations, the sensors 638 may be solid-state switches thatoperate under the influence of light, such as optical sensors, IRsensors, ultraviolet sensors, among others. Still, the switches may besolid-state devices such as transistors (e.g., FET, junction FET,MOSFET, bipolar, and the like). In other implementations, the sensors788 may include electrical conductorless switches, ultrasonic switches,accelerometers, and inertial sensors, among others.

In one aspect, the position sensor 784 may be implemented as an absolutepositioning system comprising a magnetic rotary absolute positioningsystem implemented as an AS5055EQFT single-chip magnetic rotary positionsensor available from Austria Microsystems, AG. The position sensor 784may interface with the control circuit 760 to provide an absolutepositioning system. The position may include multiple Hall-effectelements located above a magnet and coupled to a CORDIC processor, alsoknown as the digit-by-digit method and Volder's algorithm, that isprovided to implement a simple and efficient algorithm to calculatehyperbolic and trigonometric functions that require only addition,subtraction, bitshift, and table lookup operations.

In one aspect, the I-beam 764 may be implemented as a knife membercomprising a knife body that operably supports a tissue cutting bladethereon and may further include anvil engagement tabs or features andchannel engagement features or a foot. In one aspect, the staplecartridge 768 may be implemented as a standard (mechanical) surgicalfastener cartridge. In one aspect, the RF cartridge 796 may beimplemented as an RF cartridge. These and other sensors arrangements aredescribed in commonly-owned U.S. patent application Ser. No. 15/628,175,titled TECHNIQUES FOR ADAPTIVE CONTROL OF MOTOR VELOCITY OF A SURGICALSTAPLING AND CUTTING INSTRUMENT, filed Jun. 20, 2017, which is hereinincorporated by reference in its entirety.

The position, movement, displacement, and/or translation of a lineardisplacement member, such as the I-beam 764, can be measured by anabsolute positioning system, sensor arrangement, and position sensorrepresented as position sensor 784. Because the I-beam 764 is coupled tothe longitudinally movable drive member, the position of the I-beam 764can be determined by measuring the position of the longitudinallymovable drive member employing the position sensor 784. Accordingly, inthe following description, the position, displacement, and/ortranslation of the I-beam 764 can be achieved by the position sensor 784as described herein. A control circuit 760 may be programmed to controlthe translation of the displacement member, such as the I-beam 764, asdescribed herein. The control circuit 760, in some examples, maycomprise one or more microcontrollers, microprocessors, or othersuitable processors for executing instructions that cause the processoror processors to control the displacement member, e.g., the I-beam 764,in the manner described. In one aspect, a timer/counter 781 provides anoutput signal, such as the elapsed time or a digital count, to thecontrol circuit 760 to correlate the position of the I-beam 764 asdetermined by the position sensor 784 with the output of thetimer/counter 781 such that the control circuit 760 can determine theposition of the I-beam 764 at a specific time (t) relative to a startingposition. The timer/counter 781 may be configured to measure elapsedtime, count external events, or time external events.

The control circuit 760 may generate a motor set point signal 772. Themotor set point signal 772 may be provided to a motor controller 758.The motor controller 758 may comprise one or more circuits configured toprovide a motor drive signal 774 to the motor 754 to drive the motor 754as described herein. In some examples, the motor 754 may be a brushed DCelectric motor. For example, the velocity of the motor 754 may beproportional to the motor drive signal 774. In some examples, the motor754 may be a brushless DC electric motor and the motor drive signal 774may comprise a PWM signal provided to one or more stator windings of themotor 754. Also, in some examples, the motor controller 758 may beomitted, and the control circuit 760 may generate the motor drive signal774 directly.

The motor 754 may receive power from an energy source 762. The energysource 762 may be or include a battery, a super capacitor, or any othersuitable energy source. The motor 754 may be mechanically coupled to theI-beam 764 via a transmission 756. The transmission 756 may include oneor more gears or other linkage components to couple the motor 754 to theI-beam 764. A position sensor 784 may sense a position of the I-beam764. The position sensor 784 may be or include any type of sensor thatis capable of generating position data that indicate a position of theI-beam 764. In some examples, the position sensor 784 may include anencoder configured to provide a series of pulses to the control circuit760 as the I-beam 764 translates distally and proximally. The controlcircuit 760 may track the pulses to determine the position of the I-beam764. Other suitable position sensors may be used, including, forexample, a proximity sensor. Other types of position sensors may provideother signals indicating motion of the I-beam 764. Also, in someexamples, the position sensor 784 may be omitted. Where the motor 754 isa stepper motor, the control circuit 760 may track the position of theI-beam 764 by aggregating the number and direction of steps that themotor has been instructed to execute. The position sensor 784 may belocated in the end effector 792 or at any other portion of theinstrument.

The control circuit 760 may be in communication with one or more sensors788. The sensors 788 may be positioned on the end effector 792 andadapted to operate with the surgical instrument 790 to measure thevarious derived parameters such as gap distance versus time, tissuecompression versus time, and anvil strain versus time. The sensors 788may comprise a magnetic sensor, a magnetic field sensor, a strain gauge,a pressure sensor, a force sensor, an inductive sensor such as an eddycurrent sensor, a resistive sensor, a capacitive sensor, an opticalsensor, and/or any other suitable sensor for measuring one or moreparameters of the end effector 792. The sensors 788 may include one ormore sensors.

The one or more sensors 788 may comprise a strain gauge, such as amicro-strain gauge, configured to measure the magnitude of the strain inthe anvil 766 during a clamped condition. The strain gauge provides anelectrical signal whose amplitude varies with the magnitude of thestrain. The sensors 788 may comprise a pressure sensor configured todetect a pressure generated by the presence of compressed tissue betweenthe anvil 766 and the staple cartridge 768. The sensors 788 may beconfigured to detect impedance of a tissue section located between theanvil 766 and the staple cartridge 768 that is indicative of thethickness and/or fullness of tissue located therebetween.

The sensors 788 may be is configured to measure forces exerted on theanvil 766 by the closure drive system. For example, one or more sensors788 can be at an interaction point between a closure tube and the anvil766 to detect the closure forces applied by a closure tube to the anvil766. The forces exerted on the anvil 766 can be representative of thetissue compression experienced by the tissue section captured betweenthe anvil 766 and the staple cartridge 768. The one or more sensors 788can be positioned at various interaction points along the closure drivesystem to detect the closure forces applied to the anvil 766 by theclosure drive system. The one or more sensors 788 may be sampled in realtime during a clamping operation by a processor portion of the controlcircuit 760. The control circuit 760 receives real-time samplemeasurements to provide and analyze time-based information and assess,in real time, closure forces applied to the anvil 766.

A current sensor 786 can be employed to measure the current drawn by themotor 754. The force required to advance the I-beam 764 corresponds tothe current drawn by the motor 754. The force is converted to a digitalsignal and provided to the control circuit 760.

An RF energy source 794 is coupled to the end effector 792 and isapplied to the RF cartridge 796 when the RF cartridge 796 is loaded inthe end effector 792 in place of the staple cartridge 768. The controlcircuit 760 controls the delivery of the RF energy to the RF cartridge796.

Additional details are disclosed in U.S. patent application Ser. No.15/636,096, titled SURGICAL SYSTEM COUPLABLE WITH STAPLE CARTRIDGE ANDRADIO FREQUENCY CARTRIDGE, AND METHOD OF USING SAME, filed Jun. 28,2017, which is herein incorporated by reference in its entirety.

Generator Hardware

FIG. 20 is a simplified block diagram of a generator 800 configured toprovide inductorless tuning, among other benefits. Additional details ofthe generator 800 are described in U.S. Pat. No. 9,060,775, titledSURGICAL GENERATOR FOR ULTRASONIC AND ELECTROSURGICAL DEVICES, whichissued on Jun. 23, 2015, which is herein incorporated by reference inits entirety. The generator 800 may comprise a patient isolated stage802 in communication with a non-isolated stage 804 via a powertransformer 806. A secondary winding 808 of the power transformer 806 iscontained in the isolated stage 802 and may comprise a tappedconfiguration (e.g., a center-tapped or a non-center-tappedconfiguration) to define drive signal outputs 810 a, 810 b, 810 c fordelivering drive signals to different surgical instruments, such as, forexample, an ultrasonic surgical instrument, an RF electrosurgicalinstrument, and a multifunction surgical instrument which includesultrasonic and RF energy modes that can be delivered alone orsimultaneously. In particular, drive signal outputs 810 a, 810 c mayoutput an ultrasonic drive signal (e.g., a 420V root-mean-square (RMS)drive signal) to an ultrasonic surgical instrument, and drive signaloutputs 810 b, 810 c may output an RF electrosurgical drive signal(e.g., a 100V RMS drive signal) to an RF electrosurgical instrument,with the drive signal output 810 b corresponding to the center tap ofthe power transformer 806.

In certain forms, the ultrasonic and electrosurgical drive signals maybe provided simultaneously to distinct surgical instruments and/or to asingle surgical instrument, such as the multifunction surgicalinstrument, having the capability to deliver both ultrasonic andelectrosurgical energy to tissue. It will be appreciated that theelectrosurgical signal, provided either to a dedicated electrosurgicalinstrument and/or to a combined multifunction ultrasonic/electrosurgicalinstrument may be either a therapeutic or sub-therapeutic level signalwhere the sub-therapeutic signal can be used, for example, to monitortissue or instrument conditions and provide feedback to the generator.For example, the ultrasonic and RF signals can be delivered separatelyor simultaneously from a generator with a single output port in order toprovide the desired output signal to the surgical instrument, as will bediscussed in more detail below. Accordingly, the generator can combinethe ultrasonic and electrosurgical RF energies and deliver the combinedenergies to the multifunction ultrasonic/electrosurgical instrument.Bipolar electrodes can be placed on one or both jaws of the endeffector. One jaw may be driven by ultrasonic energy in addition toelectrosurgical RF energy, working simultaneously. The ultrasonic energymay be employed to dissect tissue, while the electrosurgical RF energymay be employed for vessel sealing.

The non-isolated stage 804 may comprise a power amplifier 812 having anoutput connected to a primary winding 814 of the power transformer 806.In certain forms, the power amplifier 812 may comprise a push-pullamplifier. For example, the non-isolated stage 804 may further comprisea logic device 816 for supplying a digital output to a digital-to-analogconverter (DAC) circuit 818, which in turn supplies a correspondinganalog signal to an input of the power amplifier 812. In certain forms,the logic device 816 may comprise a programmable gate array (PGA), aFPGA, programmable logic device (PLD), among other logic circuits, forexample. The logic device 816, by virtue of controlling the input of thepower amplifier 812 via the DAC circuit 818, may therefore control anyof a number of parameters (e.g., frequency, waveform shape, waveformamplitude) of drive signals appearing at the drive signal outputs 810 a,810 b, 810 c. In certain forms and as discussed below, the logic device816, in conjunction with a processor (e.g., a DSP discussed below), mayimplement a number of DSP-based and/or other control algorithms tocontrol parameters of the drive signals output by the generator 800.

Power may be supplied to a power rail of the power amplifier 812 by aswitch-mode regulator 820, e.g., a power converter. In certain forms,the switch-mode regulator 820 may comprise an adjustable buck regulator,for example. The non-isolated stage 804 may further comprise a firstprocessor 822, which in one form may comprise a DSP processor such as anAnalog Devices ADSP-21469 SHARC DSP, available from Analog Devices,Norwood, Mass., for example, although in various forms any suitableprocessor may be employed. In certain forms the DSP processor 822 maycontrol the operation of the switch-mode regulator 820 responsive tovoltage feedback data received from the power amplifier 812 by the DSPprocessor 822 via an ADC circuit 824. In one form, for example, the DSPprocessor 822 may receive as input, via the ADC circuit 824, thewaveform envelope of a signal (e.g., an RF signal) being amplified bythe power amplifier 812. The DSP processor 822 may then control theswitch-mode regulator 820 (e.g., via a PWM output) such that the railvoltage supplied to the power amplifier 812 tracks the waveform envelopeof the amplified signal. By dynamically modulating the rail voltage ofthe power amplifier 812 based on the waveform envelope, the efficiencyof the power amplifier 812 may be significantly improved relative to afixed rail voltage amplifier schemes.

In certain forms, the logic device 816, in conjunction with the DSPprocessor 822, may implement a digital synthesis circuit such as adirect digital synthesizer control scheme to control the waveform shape,frequency, and/or amplitude of drive signals output by the generator800. In one form, for example, the logic device 816 may implement a DDScontrol algorithm by recalling waveform samples stored in a dynamicallyupdated lookup table (LUT), such as a RAM LUT, which may be embedded inan FPGA. This control algorithm is particularly useful for ultrasonicapplications in which an ultrasonic transducer, such as an ultrasonictransducer, may be driven by a clean sinusoidal current at its resonantfrequency. Because other frequencies may excite parasitic resonances,minimizing or reducing the total distortion of the motional branchcurrent may correspondingly minimize or reduce undesirable resonanceeffects. Because the waveform shape of a drive signal output by thegenerator 800 is impacted by various sources of distortion present inthe output drive circuit (e.g., the power transformer 806, the poweramplifier 812), voltage and current feedback data based on the drivesignal may be input into an algorithm, such as an error controlalgorithm implemented by the DSP processor 822, which compensates fordistortion by suitably pre-distorting or modifying the waveform samplesstored in the LUT on a dynamic, ongoing basis (e.g., in real time). Inone form, the amount or degree of pre-distortion applied to the LUTsamples may be based on the error between a computed motional branchcurrent and a desired current waveform shape, with the error beingdetermined on a sample-by-sample basis. In this way, the pre-distortedLUT samples, when processed through the drive circuit, may result in amotional branch drive signal having the desired waveform shape (e.g.,sinusoidal) for optimally driving the ultrasonic transducer. In suchforms, the LUT waveform samples will therefore not represent the desiredwaveform shape of the drive signal, but rather the waveform shape thatis required to ultimately produce the desired waveform shape of themotional branch drive signal when distortion effects are taken intoaccount.

The non-isolated stage 804 may further comprise a first ADC circuit 826and a second ADC circuit 828 coupled to the output of the powertransformer 806 via respective isolation transformers 830, 832 forrespectively sampling the voltage and current of drive signals output bythe generator 800. In certain forms, the ADC circuits 826, 828 may beconfigured to sample at high speeds (e.g., 80 mega samples per second(MSPS)) to enable oversampling of the drive signals. In one form, forexample, the sampling speed of the ADC circuits 826, 828 may enableapproximately 200× (depending on frequency) oversampling of the drivesignals. In certain forms, the sampling operations of the ADC circuit826, 828 may be performed by a single ADC circuit receiving inputvoltage and current signals via a two-way multiplexer. The use ofhigh-speed sampling in forms of the generator 800 may enable, amongother things, calculation of the complex current flowing through themotional branch (which may be used in certain forms to implementDDS-based waveform shape control described above), accurate digitalfiltering of the sampled signals, and calculation of real powerconsumption with a high degree of precision. Voltage and currentfeedback data output by the ADC circuits 826, 828 may be received andprocessed (e.g., first-in-first-out (FIFO) buffer, multiplexer) by thelogic device 816 and stored in data memory for subsequent retrieval by,for example, the DSP processor 822. As noted above, voltage and currentfeedback data may be used as input to an algorithm for pre-distorting ormodifying LUT waveform samples on a dynamic and ongoing basis. Incertain forms, this may require each stored voltage and current feedbackdata pair to be indexed based on, or otherwise associated with, acorresponding LUT sample that was output by the logic device 816 whenthe voltage and current feedback data pair was acquired. Synchronizationof the LUT samples and the voltage and current feedback data in thismanner contributes to the correct timing and stability of thepre-distortion algorithm.

In certain forms, the voltage and current feedback data may be used tocontrol the frequency and/or amplitude (e.g., current amplitude) of thedrive signals. In one form, for example, voltage and current feedbackdata may be used to determine impedance phase. The frequency of thedrive signal may then be controlled to minimize or reduce the differencebetween the determined impedance phase and an impedance phase setpoint(e.g., 0°), thereby minimizing or reducing the effects of harmonicdistortion and correspondingly enhancing impedance phase measurementaccuracy. The determination of phase impedance and a frequency controlsignal may be implemented in the DSP processor 822, for example, withthe frequency control signal being supplied as input to a DDS controlalgorithm implemented by the logic device 816.

In another form, for example, the current feedback data may be monitoredin order to maintain the current amplitude of the drive signal at acurrent amplitude setpoint. The current amplitude setpoint may bespecified directly or determined indirectly based on specified voltageamplitude and power setpoints. In certain forms, control of the currentamplitude may be implemented by control algorithm, such as, for example,a proportional-integral-derivative (PID) control algorithm, in the DSPprocessor 822. Variables controlled by the control algorithm to suitablycontrol the current amplitude of the drive signal may include, forexample, the scaling of the LUT waveform samples stored in the logicdevice 816 and/or the full-scale output voltage of the DAC circuit 818(which supplies the input to the power amplifier 812) via a DAC circuit834.

The non-isolated stage 804 may further comprise a second processor 836for providing, among other things user interface (UI) functionality. Inone form, the UI processor 836 may comprise an Atmel AT91SAM9263processor having an ARM 926EJ-S core, available from Atmel Corporation,San Jose, Calif., for example. Examples of UI functionality supported bythe UI processor 836 may include audible and visual user feedback,communication with peripheral devices (e.g., via a USB interface),communication with a foot switch, communication with an input device(e.g., a touch screen display) and communication with an output device(e.g., a speaker). The UI processor 836 may communicate with the DSPprocessor 822 and the logic device 816 (e.g., via SPI buses). Althoughthe UI processor 836 may primarily support UI functionality, it may alsocoordinate with the DSP processor 822 to implement hazard mitigation incertain forms. For example, the UI processor 836 may be programmed tomonitor various aspects of user input and/or other inputs (e.g., touchscreen inputs, foot switch inputs, temperature sensor inputs) and maydisable the drive output of the generator 800 when an erroneouscondition is detected.

In certain forms, both the DSP processor 822 and the UI processor 836,for example, may determine and monitor the operating state of thegenerator 800. For the DSP processor 822, the operating state of thegenerator 800 may dictate, for example, which control and/or diagnosticprocesses are implemented by the DSP processor 822. For the UI processor836, the operating state of the generator 800 may dictate, for example,which elements of a UI (e.g., display screens, sounds) are presented toa user. The respective DSP and UI processors 822, 836 may independentlymaintain the current operating state of the generator 800 and recognizeand evaluate possible transitions out of the current operating state.The DSP processor 822 may function as the master in this relationshipand determine when transitions between operating states are to occur.The UI processor 836 may be aware of valid transitions between operatingstates and may confirm if a particular transition is appropriate. Forexample, when the DSP processor 822 instructs the UI processor 836 totransition to a specific state, the UI processor 836 may verify thatrequested transition is valid. In the event that a requested transitionbetween states is determined to be invalid by the UI processor 836, theUI processor 836 may cause the generator 800 to enter a failure mode.

The non-isolated stage 804 may further comprise a controller 838 formonitoring input devices (e.g., a capacitive touch sensor used forturning the generator 800 on and off, a capacitive touch screen). Incertain forms, the controller 838 may comprise at least one processorand/or other controller device in communication with the UI processor836. In one form, for example, the controller 838 may comprise aprocessor (e.g., a Meg168 8-bit controller available from Atmel)configured to monitor user input provided via one or more capacitivetouch sensors. In one form, the controller 838 may comprise a touchscreen controller (e.g., a QT5480 touch screen controller available fromAtmel) to control and manage the acquisition of touch data from acapacitive touch screen.

In certain forms, when the generator 800 is in a “power off” state, thecontroller 838 may continue to receive operating power (e.g., via a linefrom a power supply of the generator 800, such as the power supply 854discussed below). In this way, the controller 838 may continue tomonitor an input device (e.g., a capacitive touch sensor located on afront panel of the generator 800) for turning the generator 800 on andoff. When the generator 800 is in the power off state, the controller838 may wake the power supply (e.g., enable operation of one or moreDC/DC voltage converters 856 of the power supply 854) if activation ofthe “on/off” input device by a user is detected. The controller 838 maytherefore initiate a sequence for transitioning the generator 800 to a“power on” state. Conversely, the controller 838 may initiate a sequencefor transitioning the generator 800 to the power off state if activationof the “on/off” input device is detected when the generator 800 is inthe power on state. In certain forms, for example, the controller 838may report activation of the “on/off” input device to the UI processor836, which in turn implements the necessary process sequence fortransitioning the generator 800 to the power off state. In such forms,the controller 838 may have no independent ability for causing theremoval of power from the generator 800 after its power on state hasbeen established.

In certain forms, the controller 838 may cause the generator 800 toprovide audible or other sensory feedback for alerting the user that apower on or power off sequence has been initiated. Such an alert may beprovided at the beginning of a power on or power off sequence and priorto the commencement of other processes associated with the sequence.

In certain forms, the isolated stage 802 may comprise an instrumentinterface circuit 840 to, for example, provide a communication interfacebetween a control circuit of a surgical instrument (e.g., a controlcircuit comprising handpiece switches) and components of thenon-isolated stage 804, such as, for example, the logic device 816, theDSP processor 822, and/or the UI processor 836. The instrument interfacecircuit 840 may exchange information with components of the non-isolatedstage 804 via a communication link that maintains a suitable degree ofelectrical isolation between the isolated and non-isolated stages 802,804, such as, for example, an IR-based communication link. Power may besupplied to the instrument interface circuit 840 using, for example, alow-dropout voltage regulator powered by an isolation transformer drivenfrom the non-isolated stage 804.

In one form, the instrument interface circuit 840 may comprise a logiccircuit 842 (e.g., logic circuit, programmable logic circuit, PGA, FPGA,PLD) in communication with a signal conditioning circuit 844. The signalconditioning circuit 844 may be configured to receive a periodic signalfrom the logic circuit 842 (e.g., a 2 kHz square wave) to generate abipolar interrogation signal having an identical frequency. Theinterrogation signal may be generated, for example, using a bipolarcurrent source fed by a differential amplifier. The interrogation signalmay be communicated to a surgical instrument control circuit (e.g., byusing a conductive pair in a cable that connects the generator 800 tothe surgical instrument) and monitored to determine a state orconfiguration of the control circuit. The control circuit may comprise anumber of switches, resistors, and/or diodes to modify one or morecharacteristics (e.g., amplitude, rectification) of the interrogationsignal such that a state or configuration of the control circuit isuniquely discernable based on the one or more characteristics. In oneform, for example, the signal conditioning circuit 844 may comprise anADC circuit for generating samples of a voltage signal appearing acrossinputs of the control circuit resulting from passage of interrogationsignal therethrough. The logic circuit 842 (or a component of thenon-isolated stage 804) may then determine the state or configuration ofthe control circuit based on the ADC circuit samples.

In one form, the instrument interface circuit 840 may comprise a firstdata circuit interface 846 to enable information exchange between thelogic circuit 842 (or other element of the instrument interface circuit840) and a first data circuit disposed in or otherwise associated with asurgical instrument. In certain forms, for example, a first data circuitmay be disposed in a cable integrally attached to a surgical instrumenthandpiece or in an adaptor for interfacing a specific surgicalinstrument type or model with the generator 800. The first data circuitmay be implemented in any suitable manner and may communicate with thegenerator according to any suitable protocol, including, for example, asdescribed herein with respect to the first data circuit. In certainforms, the first data circuit may comprise a non-volatile storagedevice, such as an EEPROM device. In certain forms, the first datacircuit interface 846 may be implemented separately from the logiccircuit 842 and comprise suitable circuitry (e.g., discrete logicdevices, a processor) to enable communication between the logic circuit842 and the first data circuit. In other forms, the first data circuitinterface 846 may be integral with the logic circuit 842.

In certain forms, the first data circuit may store informationpertaining to the particular surgical instrument with which it isassociated. Such information may include, for example, a model number, aserial number, a number of operations in which the surgical instrumenthas been used, and/or any other type of information. This informationmay be read by the instrument interface circuit 840 (e.g., by the logiccircuit 842), transferred to a component of the non-isolated stage 804(e.g., to logic device 816, DSP processor 822, and/or UI processor 836)for presentation to a user via an output device and/or for controlling afunction or operation of the generator 800. Additionally, any type ofinformation may be communicated to the first data circuit for storagetherein via the first data circuit interface 846 (e.g., using the logiccircuit 842). Such information may comprise, for example, an updatednumber of operations in which the surgical instrument has been usedand/or dates and/or times of its usage.

As discussed previously, a surgical instrument may be detachable from ahandpiece (e.g., the multifunction surgical instrument may be detachablefrom the handpiece) to promote instrument interchangeability and/ordisposability. In such cases, conventional generators may be limited intheir ability to recognize particular instrument configurations beingused and to optimize control and diagnostic processes accordingly. Theaddition of readable data circuits to surgical instruments to addressthis issue is problematic from a compatibility standpoint, however. Forexample, designing a surgical instrument to remain backwardly compatiblewith generators that lack the requisite data reading functionality maybe impractical due to, for example, differing signal schemes, designcomplexity, and cost. Forms of instruments discussed herein addressthese concerns by using data circuits that may be implemented inexisting surgical instruments economically and with minimal designchanges to preserve compatibility of the surgical instruments withcurrent generator platforms.

Additionally, forms of the generator 800 may enable communication withinstrument-based data circuits. For example, the generator 800 may beconfigured to communicate with a second data circuit contained in aninstrument (e.g., the multifunction surgical instrument). In some forms,the second data circuit may be implemented in a many similar to that ofthe first data circuit described herein. The instrument interfacecircuit 840 may comprise a second data circuit interface 848 to enablethis communication. In one form, the second data circuit interface 848may comprise a tri-state digital interface, although other interfacesmay also be used. In certain forms, the second data circuit maygenerally be any circuit for transmitting and/or receiving data. In oneform, for example, the second data circuit may store informationpertaining to the particular surgical instrument with which it isassociated. Such information may include, for example, a model number, aserial number, a number of operations in which the surgical instrumenthas been used, and/or any other type of information.

In some forms, the second data circuit may store information about theelectrical and/or ultrasonic properties of an associated ultrasonictransducer, end effector, or ultrasonic drive system. For example, thefirst data circuit may indicate a burn-in frequency slope, as describedherein. Additionally or alternatively, any type of information may becommunicated to second data circuit for storage therein via the seconddata circuit interface 848 (e.g., using the logic circuit 842). Suchinformation may comprise, for example, an updated number of operationsin which the instrument has been used and/or dates and/or times of itsusage. In certain forms, the second data circuit may transmit dataacquired by one or more sensors (e.g., an instrument-based temperaturesensor). In certain forms, the second data circuit may receive data fromthe generator 800 and provide an indication to a user (e.g., a lightemitting diode indication or other visible indication) based on thereceived data.

In certain forms, the second data circuit and the second data circuitinterface 848 may be configured such that communication between thelogic circuit 842 and the second data circuit can be effected withoutthe need to provide additional conductors for this purpose (e.g.,dedicated conductors of a cable connecting a handpiece to the generator800). In one form, for example, information may be communicated to andfrom the second data circuit using a one-wire bus communication schemeimplemented on existing cabling, such as one of the conductors usedtransmit interrogation signals from the signal conditioning circuit 844to a control circuit in a handpiece. In this way, design changes ormodifications to the surgical instrument that might otherwise benecessary are minimized or reduced. Moreover, because different types ofcommunications implemented over a common physical channel can befrequency-band separated, the presence of a second data circuit may be“invisible” to generators that do not have the requisite data readingfunctionality, thus enabling backward compatibility of the surgicalinstrument.

In certain forms, the isolated stage 802 may comprise at least oneblocking capacitor 850-1 connected to the drive signal output 810 b toprevent passage of DC current to a patient. A single blocking capacitormay be required to comply with medical regulations or standards, forexample. While failure in single-capacitor designs is relativelyuncommon, such failure may nonetheless have negative consequences. Inone form, a second blocking capacitor 850-2 may be provided in serieswith the blocking capacitor 850-1, with current leakage from a pointbetween the blocking capacitors 850-1, 850-2 being monitored by, forexample, an ADC circuit 852 for sampling a voltage induced by leakagecurrent. The samples may be received by the logic circuit 842, forexample. Based changes in the leakage current (as indicated by thevoltage samples), the generator 800 may determine when at least one ofthe blocking capacitors 850-1, 850-2 has failed, thus providing abenefit over single-capacitor designs having a single point of failure.

In certain forms, the non-isolated stage 804 may comprise a power supply854 for delivering DC power at a suitable voltage and current. The powersupply may comprise, for example, a 400 W power supply for delivering a48 VDC system voltage. The power supply 854 may further comprise one ormore DC/DC voltage converters 856 for receiving the output of the powersupply to generate DC outputs at the voltages and currents required bythe various components of the generator 800. As discussed above inconnection with the controller 838, one or more of the DC/DC voltageconverters 856 may receive an input from the controller 838 whenactivation of the “on/off” input device by a user is detected by thecontroller 838 to enable operation of, or wake, the DC/DC voltageconverters 856.

FIG. 21 illustrates an example of a generator 900, which is one form ofthe generator 800 (FIG. 20). The generator 900 is configured to delivermultiple energy modalities to a surgical instrument. The generator 900provides RF and ultrasonic signals for delivering energy to a surgicalinstrument either independently or simultaneously. The RF and ultrasonicsignals may be provided alone or in combination and may be providedsimultaneously. As noted above, at least one generator output candeliver multiple energy modalities (e.g., ultrasonic, bipolar ormonopolar RF, irreversible and/or reversible electroporation, and/ormicrowave energy, among others) through a single port, and these signalscan be delivered separately or simultaneously to the end effector totreat tissue. The generator 900 comprises a processor 902 coupled to awaveform generator 904. The processor 902 and waveform generator 904 areconfigured to generate a variety of signal waveforms based oninformation stored in a memory coupled to the processor 902, not shownfor clarity of disclosure. The digital information associated with awaveform is provided to the waveform generator 904 which includes one ormore DAC circuits to convert the digital input into an analog output.The analog output is fed to an amplifier 1106 for signal conditioningand amplification. The conditioned and amplified output of the amplifier906 is coupled to a power transformer 908. The signals are coupledacross the power transformer 908 to the secondary side, which is in thepatient isolation side. A first signal of a first energy modality isprovided to the surgical instrument between the terminals labeledENERGY1 and RETURN. A second signal of a second energy modality iscoupled across a capacitor 910 and is provided to the surgicalinstrument between the terminals labeled ENERGY2 and RETURN. It will beappreciated that more than two energy modalities may be output and thusthe subscript “n” may be used to designate that up to n ENERGYnterminals may be provided, where n is a positive integer greater than 1.It also will be appreciated that up to “n” return paths RETURNn may beprovided without departing from the scope of the present disclosure.

A first voltage sensing circuit 912 is coupled across the terminalslabeled ENERGY1 and the RETURN path to measure the output voltagetherebetween. A second voltage sensing circuit 924 is coupled across theterminals labeled ENERGY2 and the RETURN path to measure the outputvoltage therebetween. A current sensing circuit 914 is disposed inseries with the RETURN leg of the secondary side of the powertransformer 908 as shown to measure the output current for either energymodality. If different return paths are provided for each energymodality, then a separate current sensing circuit should be provided ineach return leg. The outputs of the first and second voltage sensingcircuits 912, 924 are provided to respective isolation transformers 916,922 and the output of the current sensing circuit 914 is provided toanother isolation transformer 918. The outputs of the isolationtransformers 916, 928, 922 in the on the primary side of the powertransformer 908 (non-patient isolated side) are provided to a one ormore ADC circuit 926. The digitized output of the ADC circuit 926 isprovided to the processor 902 for further processing and computation.The output voltages and output current feedback information can beemployed to adjust the output voltage and current provided to thesurgical instrument and to compute output impedance, among otherparameters. Input/output communications between the processor 902 andpatient isolated circuits is provided through an interface circuit 920.Sensors also may be in electrical communication with the processor 902by way of the interface circuit 920.

In one aspect, the impedance may be determined by the processor 902 bydividing the output of either the first voltage sensing circuit 912coupled across the terminals labeled ENERGY1/RETURN or the secondvoltage sensing circuit 924 coupled across the terminals labeledENERGY2/RETURN by the output of the current sensing circuit 914 disposedin series with the RETURN leg of the secondary side of the powertransformer 908. The outputs of the first and second voltage sensingcircuits 912, 924 are provided to separate isolations transformers 916,922 and the output of the current sensing circuit 914 is provided toanother isolation transformer 916. The digitized voltage and currentsensing measurements from the ADC circuit 926 are provided the processor902 for computing impedance. As an example, the first energy modalityENERGY1 may be ultrasonic energy and the second energy modality ENERGY2may be RF energy. Nevertheless, in addition to ultrasonic and bipolar ormonopolar RF energy modalities, other energy modalities includeirreversible and/or reversible electroporation and/or microwave energy,among others. Also, although the example illustrated in FIG. 21 shows asingle return path RETURN may be provided for two or more energymodalities, in other aspects, multiple return paths RETURNn may beprovided for each energy modality ENERGYn. Thus, as described herein,the ultrasonic transducer impedance may be measured by dividing theoutput of the first voltage sensing circuit 912 by the current sensingcircuit 914 and the tissue impedance may be measured by dividing theoutput of the second voltage sensing circuit 924 by the current sensingcircuit 914.

As shown in FIG. 21, the generator 900 comprising at least one outputport can include a power transformer 908 with a single output and withmultiple taps to provide power in the form of one or more energymodalities, such as ultrasonic, bipolar or monopolar RF, irreversibleand/or reversible electroporation, and/or microwave energy, amongothers, for example, to the end effector depending on the type oftreatment of tissue being performed. For example, the generator 900 candeliver energy with higher voltage and lower current to drive anultrasonic transducer, with lower voltage and higher current to drive RFelectrodes for sealing tissue, or with a coagulation waveform for spotcoagulation using either monopolar or bipolar RF electrosurgicalelectrodes. The output waveform from the generator 900 can be steered,switched, or filtered to provide the frequency to the end effector ofthe surgical instrument. The connection of an ultrasonic transducer tothe generator 900 output would be preferably located between the outputlabeled ENERGY1 and RETURN as shown in FIG. 21. In one example, aconnection of RF bipolar electrodes to the generator 900 output would bepreferably located between the output labeled ENERGY2 and RETURN. In thecase of monopolar output, the preferred connections would be activeelectrode (e.g., pencil or other probe) to the ENERGY2 output and asuitable return pad connected to the RETURN output.

Additional details are disclosed in U.S. Patent Application PublicationNo. 2017/0086914, titled TECHNIQUES FOR OPERATING GENERATOR FORDIGITALLY GENERATING ELECTRICAL SIGNAL WAVEFORMS AND SURGICALINSTRUMENTS, which published on Mar. 30, 2017, which is hereinincorporated by reference in its entirety.

As used throughout this description, the term “wireless” and itsderivatives may be used to describe circuits, devices, systems, methods,techniques, communications channels, etc., that may communicate datathrough the use of modulated electromagnetic radiation through anon-solid medium. The term does not imply that the associated devices donot contain any wires, although in some aspects they might not. Thecommunication module may implement any of a number of wireless or wiredcommunication standards or protocols, including but not limited to Wi-Fi(IEEE 802.11 family), WiMAX (IEEE 802.16 family), IEEE 802.20, long termevolution (LTE), Ev-DO, HSPA+, HSDPA+, HSUPA+, EDGE, GSM, GPRS, CDMA,TDMA, DECT, Bluetooth, Ethernet derivatives thereof, as well as anyother wireless and wired protocols that are designated as 3G, 4G, 5G,and beyond. The computing module may include a plurality ofcommunication modules. For instance, a first communication module may bededicated to shorter range wireless communications such as Wi-Fi andBluetooth and a second communication module may be dedicated to longerrange wireless communications such as GPS, EDGE, GPRS, CDMA, WiMAX, LTE,Ev-DO, and others.

As used herein a processor or processing unit is an electronic circuitwhich performs operations on some external data source, usually memoryor some other data stream. The term is used herein to refer to thecentral processor (central processing unit) in a system or computersystems (especially systems on a chip (SoCs)) that combine a number ofspecialized “processors.”

As used herein, a system on a chip or system on chip (SoC or SOC) is anintegrated circuit (also known as an “IC” or “chip”) that integrates allcomponents of a computer or other electronic systems. It may containdigital, analog, mixed-signal, and often radio-frequency functions—allon a single substrate. A SoC integrates a microcontroller (ormicroprocessor) with advanced peripherals like graphics processing unit(GPU), Wi-Fi module, or coprocessor. A SoC may or may not containbuilt-in memory.

As used herein, a microcontroller or controller is a system thatintegrates a microprocessor with peripheral circuits and memory. Amicrocontroller (or MCU for microcontroller unit) may be implemented asa small computer on a single integrated circuit. It may be similar to aSoC; an SoC may include a microcontroller as one of its components. Amicrocontroller may contain one or more core processing units (CPUs)along with memory and programmable input/output peripherals. Programmemory in the form of Ferroelectric RAM, NOR flash or OTP ROM is alsooften included on chip, as well as a small amount of RAM.Microcontrollers may be employed for embedded applications, in contrastto the microprocessors used in personal computers or other generalpurpose applications consisting of various discrete chips.

As used herein, the term controller or microcontroller may be astand-alone IC or chip device that interfaces with a peripheral device.This may be a link between two parts of a computer or a controller on anexternal device that manages the operation of (and connection with) thatdevice.

Any of the processors or microcontrollers described herein, may beimplemented by any single core or multicore processor such as thoseknown under the trade name ARM Cortex by Texas Instruments. In oneaspect, the processor may be an LM4F230H5QR ARM Cortex-M4F ProcessorCore, available from Texas Instruments, for example, comprising on-chipmemory of 256 KB single-cycle flash memory, or other non-volatilememory, up to 40 MHz, a prefetch buffer to improve performance above 40MHz, a 32 KB single-cycle serial random access memory (SRAM), internalread-only memory (ROM) loaded with StellarisWare® software, 2 KBelectrically erasable programmable read-only memory (EEPROM), one ormore pulse width modulation (PWM) modules, one or more quadratureencoder inputs (QEI) analog, one or more 12-bit Analog-to-DigitalConverters (ADC) with 12 analog input channels, details of which areavailable for the product datasheet.

In one aspect, the processor may comprise a safety controller comprisingtwo controller-based families such as TMS570 and RM4x known under thetrade name Hercules ARM Cortex R4, also by Texas Instruments. The safetycontroller may be configured specifically for IEC 61508 and ISO 26262safety critical applications, among others, to provide advancedintegrated safety features while delivering scalable performance,connectivity, and memory options.

Modular devices include the modules (as described in connection withFIGS. 3 and 9, for example) that are receivable within a surgical huband the surgical devices or instruments that can be connected to thevarious modules in order to connect or pair with the correspondingsurgical hub. The modular devices include, for example, intelligentsurgical instruments, medical imaging devices, suction/irrigationdevices, smoke evacuators, energy generators, ventilators, insufflators,and displays. The modular devices described herein can be controlled bycontrol algorithms. The control algorithms can be executed on themodular device itself, on the surgical hub to which the particularmodular device is paired, or on both the modular device and the surgicalhub (e.g., via a distributed computing architecture). In someexemplifications, the modular devices' control algorithms control thedevices based on data sensed by the modular device itself (i.e., bysensors in, on, or connected to the modular device). This data can berelated to the patient being operated on (e.g., tissue properties orinsufflation pressure) or the modular device itself (e.g., the rate atwhich a knife is being advanced, motor current, or energy levels). Forexample, a control algorithm for a surgical stapling and cuttinginstrument can control the rate at which the instrument's motor drivesits knife through tissue according to resistance encountered by theknife as it advances.

Long Distance Communication and Condition Handling of Devices and Data

Surgical procedures are performed by different surgeons at differentlocations, some with much less experience than others. For a givensurgical procedure, there are many parameters that can be varied toattempt to realize a desired outcome. For example, for a given surgicalprocedure which utilizes energy supplied by a generator, the surgeonoften relies on experience alone for determining which mode of energy toutilize, which level of output power to utilize, the duration of theapplication of the energy, etc., in order to attempt to realize thedesired outcome. To increase the likelihood of realizing desiredoutcomes for a plurality of different surgical procedures, each surgeonshould be provided with best practice recommendations which are based onimportant relationships identified within large, accurate data sets ofinformation associated with multiple surgical procedures performed inmultiple locations over time. However, there are many ways that suchdata sets can be rendered compromised, inaccurate, and/or unsecure,thereby calling into question the applicability of the best practicerecommendations derived therefrom. For example, for data sent from asource to a cloud-based system, the data can be lost while in transit tothe cloud-based system, the data can be corrupted while in transit tothe cloud-based system, the confidentiality of the data can be comprisedwhile in transit to the cloud-based system, and/or the content of thedata can be altered while in transit to the cloud-based system.

A plurality of operating rooms located in multiple locations can each beequipped with a surgical hub. When a given surgical procedure isperformed in a given operating room, the surgical hub can receive dataassociated with the surgical procedure and communicate the data to acloud-based system. Over time, the cloud-based system will receive largedata sets of information associated with the surgeries. The data can becommunicated from the surgical hubs to the cloud-based system in amanner which allows for the cloud-based system to (1) verify theauthenticity of the communicated data, (2) authenticate each of therespective surgical hubs which communicated the data, and (3) trace thepaths the data followed from the respective surgical hubs to thecloud-based system.

Accordingly, in one aspect, the present disclosure provides a surgicalhub for transmitting generator data associated with a surgical procedureto a cloud-based system communicatively coupled to a plurality ofsurgical hubs. The surgical hub comprises a processor and a memorycoupled to the processor. The memory stores instructions executable bythe processor to receive data from a generator, encrypt the data,generate a message authentication code (MAC) based on the data, generatea datagram comprising the encrypted data, the generated MAC, a sourceidentifier, and a destination identifier, and transmit the datagram to acloud-based system. The data is structured into a data packet comprisingat least two of the following fields: a field that indicates the sourceof the data, a unique time stamp, a field indicating an energy mode ofthe generator, a field indicating the power output of the generator, anda field indicating a duration of the power output of the generator. Thedatagram allows for the cloud-based system to decrypt the encrypted dataof the transmitted datagram, verify integrity of the data based on theMAC, authenticate the surgical hub as the source of the datagram, andvalidate a transmission path followed by the datagram between thesurgical hub and the cloud-based system. In various aspects, the presentdisclosure provides a control circuit to transmit generator dataassociated with a surgical procedure to a cloud-based systemcommunicatively coupled to a plurality of surgical hubs, as describedabove. In various aspects, the present disclosure provides anon-transitory computer-readable medium storing computer-readableinstructions which, when executed, causes a machine to transmitgenerator data associated with a surgical procedure to a cloud-basedsystem communicatively coupled to a plurality of surgical hubs, asdescribed above.

In another aspect, the present disclosure provides a cloud-based systemcommunicatively coupled to a plurality of surgical hubs. Each surgicalhub is configured to transmit generator data associated with a surgicalprocedure to the cloud-based system. The cloud-based system comprises aprocessor and a memory coupled to the processor. The memory storesinstructions executable by the processor to receive a datagram generatedby a surgical hub, decrypt the encrypted generator data of the receiveddatagram, verify integrity of the generator data based on the MAC,authenticate the surgical hub as the source of the datagram, andvalidate a transmission path followed by the datagram between thesurgical hub and the cloud-based system. The datagram comprisesgenerator data captured from a generator associated with the surgicalhub, a MAC generated by the surgical hub based on the generator data, asource identifier, and a destination identifier. The generator data hasbeen encrypted by the surgical hub. The encrypted generator data hasbeen structured into a data packet comprising at least two of thefollowing fields: a field that indicates the source of the data, aunique time stamp, a field indicating an energy mode, a field indicatingpower output, and a field indicating a duration of applied power.

In various aspects, the present disclosure provides a control circuit totransmit generator data associated with a surgical procedure to thecloud-based system. In various aspects, the present disclosure providesa non-transitory computer-readable medium storing computer-readableinstructions which, when executed, causes a machine to transmitgenerator data associated with a surgical procedure to the cloud-basedsystem.

In another aspect, the present disclosure provides a method, comprisingcapturing data from a combination generator of a surgical hub during asurgical procedure, wherein the combination generator is configured tosupply two or more different modes of energy. Encrypting the capturedgenerator data, generating a MAC based on the captured generator data,generating a datagram comprising the encrypted generator data, the MAC,a source identifier, and a destination identifier, and communicating thedatagram from the surgical hub to a cloud-based system. The datagramallows for the cloud-based system to authenticate integrity of thecommunicated generator data, authenticate the surgical hub as a sourceof the datagram, and determine a communication path followed by thedatagram between the surgical hub and the cloud-based system.

By sending captured generator data from a plurality of differentsurgical hubs to a cloud-based system, the cloud-based system is able toquickly build large data sets of information associated with multiplesurgical procedures performed in multiple locations over time.Furthermore, due to the composition of the respective datagrams, for agiven datagram, the cloud-based system is able to determine whether thedatagram was originally sent by one of the surgical hubs (sourcevalidation), thereby providing an indication that the generator datareceived at the cloud-based system is legitimate data. For the givendatagram, the cloud-based system is also able to determine whether thegenerator data received at the cloud-based system is identical to thegenerator data sent by the given surgical hub (data integrity), therebyallowing for the authenticity of the received generator data to beverified. Additionally, for the given datagram, the cloud-based systemis also able to re-trace the communication path followed by thedatagram, thereby allowing for enhanced troubleshooting if a datagramreceived by the cloud-based system was originally sent from a deviceother than the surgical hubs and/or if the content of the datagram wasaltered while in transit to the cloud-based system. Notably, the presentdisclosure references generator data in particular. Here, the presentdisclosure should not be limited as being able to process only generatordata. For example, the surgical hub 206 and/or the cloud-based system205 may process data received from any component (e.g., imaging module238, generator module 240, smoke evacuator module 226,suction/irrigation module 228, communication module 230, processormodule 232, storage array 234, smart device/instrument 235, non-contactsensor module 242, robot hub 222, a non-robotic surgical hub 206,wireless smart device/instrument 235, visualization system 208) of thesurgical system 202 that is coupled to the surgical hub 206 and/or datafrom any devices (e.g., endoscope 239, energy device 241) coupledto/through such components (e.g., see FIGS. 9-10), in a similar manneras discussed herein.

Unfortunately, the outcome of a surgical procedure is not alwaysoptimal. For example, a failure event such as a surgical device failure,an unwanted tissue perforation, an unwanted post-operative bleeding, orthe like can occur. The occurrence of a failure event can be attributedto any of a variety of different people and devices, including one ormore surgeons, one or more devices associated with the surgery, acondition of the patient, and combinations thereof. When a given failureevent occurs, it is not always clear regarding who or what caused thefailure event or how the occurrence of the failure event can bemitigated in connection with a future surgery.

During a given surgical procedure, a large amount of data associatedwith the surgical procedure can be generated and captured. All of thecaptured data can be communicated to a surgical hub, and the captureddata can be time-stamped either before or after being received at thesurgical hub. When a failure event associated with the surgicalprocedure is detected and/or identified, it can be determined which ofthe captured data is associated with the failure event and/or which ofthe captured data is not associated with the failure event. In makingthis determination, the failure event can be defined to include a periodof time prior to the detection/identification of the failure event. Oncethe determination is made regarding the captured data associated withthe failure event, the surgical hub can separate the captured dataassociated with the failure event from all other captured data, and thecaptured data can be separated based on tagging, flagging, or the like.The captured data associated with the failure event can then bechronologized based on the time-stamping and the defined time periodapplicable to the failure event. The chronologized captured data canthen be communicated to a cloud-based system on a prioritized basis foranalysis, where the prioritized basis is relative to the captured datawhich is not associated with the failure event. Whether or not theanalysis identifies a device associated with the surgical procedure asthe causation of the failure event, the surgical hub can tag the devicefor removal of the device from future use, further analysis of thedevice, and/or to return the device to the manufacturer.

When a given surgical procedure is performed, a large amount of dataassociated with the surgical procedure can be generated and captured.All of the captured data can be communicated to a surgical hub, wherethe information can be stripped of all “personal” associations. Thecaptured data can be time-stamped before being received at the surgicalhub, after being received at the surgical hub, before being stripped ofthe “personal” associations, or after being stripped of the “personal”associations. The surgical hub can communicate the stripped data to thecloud-based system for subsequent analysis. Over time, the cloud-basedsystem will receive large data sets of information associated with thesurgeries. Accordingly, in one aspect, the present disclosure provides asurgical hub for prioritizing surgical data associated with a surgicalprocedure to a cloud-based system communicatively coupled to a pluralityof surgical hubs. The surgical hub comprises a processor and a memorycoupled to the processor. The memory stores instructions executable bythe processor to capture surgical data, wherein the surgical datacomprises data associated with a surgical device, time-stamp thecaptured surgical data, identify a failure event, identify a time periodassociated with the failure event, isolate failure event surgical datafrom surgical data not associated with the failure event based on theidentified time period, chronologize the failure event surgical data bytime-stamp, encrypt the chronologized failure event surgical data,generate a datagram comprising the encrypted failure event surgicaldata, and transmit the datagram to a cloud-based system. The datagram isstructured to include a field which includes a flag that prioritizes theencrypted failure event surgical data over other encrypted data of thedatagram. The datagram allows for the cloud-based system to decrypt theencrypted failure event surgical data, focus analysis on the failureevent surgical data rather than surgical data not associated with thefailure event, and flag the surgical device associated with the failureevent for at least one of the following: removal from an operating room,return to a manufacturer, or future inoperability in the cloud-basedsystem.

In various aspects, the present disclosure provides a control circuit toprioritize surgical data associated with a surgical procedure to acloud-based system communicatively coupled to a plurality of surgicalhubs. In various aspects, the present disclosure provides anon-transitory computer-readable medium storing computer-readableinstructions which, when executed, causes a machine to prioritizesurgical data associated with a surgical procedure to a cloud-basedsystem communicatively coupled to a plurality of surgical hubs.

In another aspect, the present disclosure provides a method, comprisingcapturing data during a surgical procedure, communicating the captureddata to a surgical hub, time-stamping the captured data, identifying afailure event associated with the surgical procedure, determining whichof the captured data is associated with the failure event, separatingthe captured data associated with the failure event from all othercaptured data, chronologizing the captured data associated with thefailure event, and communicating the chronologized captured data to acloud-based system on a prioritized basis.

By capturing the large amount of data associated with the surgicalprocedure, and with having the captured data time-stamped, the portionof the captured data which is relevant to the detected/identifiedfailure event can be more easily isolated from all of the other captureddata, thereby allowing for a more focused subsequent analysis on justthe relevant captured data. The data associated with the failure eventcan then be chronologized (this requires less processing power thanchronologizing all of the captured data), thereby allowing for theevents leading up to the detection/identification of the failure eventto be more easily considered during the subsequent analysis of thefailure event. The chronologized data can then be communicated to thecloud-based system (this requires less communication resources thancommunicating all of the captured data at the same time) on aprioritized basis, thereby allowing for the focused subsequent analysisof the fault event to be performed by the cloud-based system in a moretime-sensitive manner.

To help ensure that the best practice recommendations are developedbased on accurate data, it would be desirable to ensure that thegenerator data received at the cloud-based system is the same as thegenerator data communicated to the cloud-based system. Also, to help tobe able to determine the cause of a failure event as quickly aspossible, it would be desirable to ensure that surgical data associatedwith the failure event is communicated to the cloud-based system in aprioritized manner (relative to surgical data not associated with thefailure event) so that analysis of the surgical data can be performed inan expedited manner.

Aspects of a system and method for communicating data associated with asurgical procedure are described herein. As shown in FIG. 9, variousaspects of the computer implemented interactive surgical system 200includes a device/instrument 235, a generator module 240, a modularcontrol tower 236, and a cloud-based system 205. As shown in FIG. 10,the device/instrument 235, the generator module 240, and the modularcontrol tower 236 are components/portions of a surgical hub 206.

In various aspects, the generator module 240 of the surgical hub 206 cansupply radio-frequency energy such as monopolar radio-frequency energy,bipolar radio-frequency energy, and advanced bipolar energy and/orultrasonic energy to a device/instrument 235 for use in a surgicalprocedure. Thus, the generator module 240 may be referred to as acombination generator. An example of such a combination generator isshown in FIG. 22, where the combination generator 3700 is shown asincluding a monopolar module 3702, a bipolar module 3704, an advancedbipolar module 3706, and an ultrasound module 3708. When utilized duringa surgical procedure, the respective energy modules (e.g., 3702, 3704,3706, and/or 3708) of the combination generator 3700 can providegenerator data such as type of energy supplied to the device instrument(e.g., radio-frequency energy, ultrasound energy, radio-frequency energyand ultrasound energy), type of radio-frequency energy (e.g., monoplar,bipolar, advanced bipolar), frequency, power output, duration, etc., tothe data communication module 3710 of the combination generator 3700.

FIG. 23 illustrates various aspects of a method of capturing data from acombination generator 3700 and communicating the captured generator datato a cloud-based system 205. Notably, as discussed herein, the presentdisclosure should not be limited to processing generator data. As such,the method of FIG. 23 similarly extends to other types of data receivedfrom other components coupled to the surgical hub 206 (e.g., imagingmodule data, smoke evacuator data, suction/irrigation data,device/instrument data). The method comprises (1) capturing 3712 datafrom a combination generator 3700 of a surgical hub 206 during asurgical procedure, wherein the combination generator 3700 is configuredto supply two or more different modes of energy; (2) encrypting 3714 thecaptured generator data; (3) generating 3716 a MAC based on the capturedgenerator data; (4) generating 3718 a datagram comprising the encryptedgenerator data, the MAC, a source identifier, and a destinationidentifier; and (5) communicating 3720 the datagram from the surgicalhub 206 to a cloud-based system 205, wherein the datagram allows for thecloud-based system 205 to (i) authenticate integrity of the communicatedgenerator data, (ii) authenticate the surgical hub as a source of thedatagram, and (iii) determine a communication path followed by thedatagram between the surgical hub 206 and the cloud-based system 205.

More specifically, once the generator data is received at the datacommunication module 3710 of the combination generator 3700, thegenerator data can be communicated to the modular communication hub 203of the surgical hub 206 for subsequent communication to the cloud-basedsystem 205. The data communication module 3710 can communicate thegenerator data to the modular communication hub 203 serially over asingle communication line or in parallel over a plurality ofcommunication lines, and such communication can be performed in realtime or near real time. Alternatively, such communication can beperformed in batches.

According to various aspects, prior to communicating the generator datato the modular communication hub 203, a component of the combinationgenerator 3700 (e.g., the data communication module 3710) can organizethe generator data into data packets. An example of such a data packetis shown in FIG. 24, where the data packet 3722 includes a preamble 3724or self-describing data header which defines what the data is (e.g.,combination generator data—CGD) and fields which indicate where thegenerator data came from [e.g., combination generator ID number3726—(e.g., 017), a unique time stamp 3728 (e.g., 08:27:16), the energymode utilized 3730 (e.g., RF, U, RF+U), the type of radio-frequencyenergy or radio frequency mode 3732 (e.g., MP, BP, ABP), the frequency3734 (e.g., 500 Khz), the power output 3736 (e.g., 30 watts), theduration of applied power 3738 (e.g., 45 milliseconds), and anauthentication/identification certificate of the data point 3740 (e.g.,01101011001011). The example data packet 3722 may be considered aself-describing data packet, and the combination generator 3700 andother intelligent devices (e.g., the surgical hub 206) can use theself-describing data packets to minimize data size and data-handlingresources. Again, as discussed herein, the present disclosure should notbe limited to processing generator data received from a combinationgenerator 3700. As such, the data packet 3722 of FIG. 24 similarlyextends to other types of data received from other components coupled tothe surgical hub 206. In one aspect, the data packet 3722 may comprisedata associated with endoscope 239 (e.g., image data) received from acomponent of the imaging module 238. In another aspect, the data packet3722 may comprises data associated with an evacuation system (e.g.,pressures, particle counts, flow rates, motor speeds) received from acomponent of the smoke evacuator module 226. In yet another aspect, thedata packet 3722 may comprise data associated with a device/instrument(e.g., temperature sensor data, firing data, sealing data) received froma component of the device/instrument 235. In various other aspects, thedata packet 3722 may similarly comprise data received from othercomponents coupled to the surgical hub 206 (e.g., suction/irrigationmodule 228, non-contact sensor module 242)

Additionally, the data communication module 3710 can compress thegenerator data and/or encrypt the generator data prior to communicatingthe generator data to the modular communication hub 203. The specificmethod of compressing and/or encrypting can be the same as or differentfrom the compressing and/or encrypting which may be performed by thesurgical hub 206 as described in more detail below.

The modular communication hub 203 can receive the generator datacommunicated from the combination generator 3700 (e.g., via the datacommunication module 3710), and the generator data can be subsequentlycommunicated to the cloud-based system 205 (e.g., through the Internet).According to various aspects, the modular communication hub 203 canreceive the generator data through a hub/switch 207/209 of the modularcommunication hub 203 (See FIG. 10), and the generator data can becommunicated to the cloud-based system 205 by a router 211 of themodular communication hub 203 (See FIG. 10). The generator data may becommunicated in real time, near real time, or in batches to thecloud-based system 205 or may be stored at the surgical hub 206 prior tobeing communicated to the cloud-based system 205. The generator data canbe stored, for example, at the storage array 234 or at the memory 249 ofthe computer system 210 of the surgical hub 206.

In various aspects, for instances where the generator data received atthe modular communication hub 203 is not encrypted, prior to thereceived generator data being communicated to the cloud-based system205, the generator data is encrypted to help ensure the confidentialityof the generator data, either while it is being stored at the surgicalhub 206 or while it is being transmitted to the cloud 204 using theInternet or other computer networks. According to various aspects, acomponent of the surgical hub 206 utilizes an encryption algorithm toconvert the generator data from a readable version to an encodedversion, thereby forming the encrypted generator data. The component ofthe surgical hub 206 which utilizes/executes the encryption algorithmcan be, for example, the processor module 232, the processor 244 of thecomputer system 210, and/or combinations thereof. The utilized/executedencryption algorithm can be a symmetric encryption algorithm and/or anasymmetric encryption algorithm.

Using a symmetric encryption algorithm, the surgical hub 206 wouldencrypt the generator data using a shared secret (e.g., private key,passphrase, password). In such an aspect, a recipient of the encryptedgenerator data (e.g., cloud-based system 205) would then decrypt theencrypted generator data using the same shared secret. In such anaspect, the surgical hub 206 and the recipient would need access toand/or knowledge of the same shared secret. In one aspect, a sharedsecret can be generated/chosen by the surgical hub 206 and securelydelivered (e.g., physically) to the recipient before encryptedcommunications to the recipient.

Alternatively, using an asymmetric encryption algorithm, the surgicalhub 206 would encrypt the generator data using a public key associatedwith a recipient (e.g., cloud-based system 205). This public key couldbe received by the surgical hub 206 from a certificate authority thatissues a digital certificate certifying the public key as owned by therecipient. The certificate authority can be any entity trusted by thesurgical hub 206 and the recipient. In such an aspect, the recipient ofthe encrypted generator data would then decrypt the encrypted generatordata using a private key (i.e., known only by the recipient) paired tothe public key used by the surgical hub 206 to encrypt the generatordata. Notably, in such an aspect, the encrypted generator data can onlybe decrypted using the recipient's private key.

According to aspects of the present disclosure, components (e.g.,surgical device/instrument 235, energy device 241, endoscope 239) of thesurgical system 202 are associated with unique identifiers, which can bein the form of serial numbers. As such, according to various aspects ofthe present disclosure, when a component is coupled to a surgical hub206, the component may establish a shared secret with the surgical hub206 using the unique identifier of the coupled component as the sharedsecret. Further, in such an aspect, the component may derive a checksumvalue by applying a checksum function/algorithm to the unique identifierand/or other data being communicated to the surgical hub 206. Here, thechecksum function/algorithm is configured to output a significantlydifferent checksum value if there is a modification to the underlyingdata.

In one aspect, the component may initially encrypt the unique identifierof a coupled component using a public key associated with the surgicalhub (e.g., received by the component from the surgical hub 206upon/after connection) and communicate the encrypted unique identifierto the surgical hub 206. In other aspects, the component may encrypt theunique identifier and the derived checksum value of a coupled componentusing a public key associated with the surgical hub 206 and communicatethe encrypted unique identifier and linked/associated checksum value tothe surgical hub 206.

In yet other aspects, the component may encrypt the unique identifierand a checksum function/algorithm using a public key associated with thesurgical hub 206 and communicate the encrypted unique identifier and thechecksum function/algorithm to the surgical hub 206. In such aspects,the surgical hub 206 would then decrypt the encrypted unique identifieror the encrypted unique identifier and the linked/associated checksumvalue or the encrypted unique identifier and the checksumfunction/algorithm using a private key (i.e., known only by the surgicalhub 206) paired to the public key used by the component to encrypt theunique identifier.

Since the encrypted unique identifier can only be decrypted using thesurgical hub's 206 private key and the private key is only known by thesurgical hub, this is a secure way to communicate a shared secret (e.g.,the unique identifier of the coupled component) to the surgical hub 206.Further, in aspects where a checksum value is linked to/associated withthe unique identifier, the surgical hub 206 may apply the same checksumfunction/algorithm to the decrypted unique identifier to generate avalidating checksum value. If the validating checksum value matches thedecrypted checksum value, the integrity of the decrypted uniqueidentifier is further verified. Further, in such aspects, with a sharedsecret established, the component can encrypt future communications tothe surgical hub 206, and the surgical hub 206 can decrypt the futurecommunications from the component using the shared secret (e.g., theunique identifier of the coupled component). Here, according to variousaspects, a checksum value may be derived for and communicated with eachcommunication between the component and the surgical hub 206 (e.g., thechecksum value based on the communicated data or at least a designatedportion thereof). Here, a checksum function/algorithm (e.g., known bythe surgical hub 206 and/or component or communicated when establishingthe shared secret between the surgical hub 206 and the component asdescribed above) may be used to generate validating checksum values forcomparison with communicated checksum values to further verify theintegrity of communicated data in each communication.

Notably, asymmetric encryption algorithms may be complex and may requiresignificant computational resources to execute each communication. Assuch, establishing the unique identifier of the coupled component as theshared secret is not only quicker (e.g., no need to generate a sharedsecret using a pseudorandom key generator) but also increasescomputational efficiency (e.g., enables the execution of faster, lesscomplex symmetric encryption algorithms) for all subsequentcommunications. In various aspects, this established shared secret maybe utilized by the component and surgical hub 206 until the component isdecoupled from the surgical hub (e.g., surgical procedure ended).

According to other aspects of the present disclosure, components (e.g.,surgical device/instrument 235, energy device 241, endoscope 239) of thesurgical system 202 may comprise sub-components (e.g., handle, shaft,end effector, cartridge) each associated with its own unique identifier.As such, according to various aspects of the present disclosure, when acomponent is coupled to the surgical hub 206, the component mayestablish a shared secret with the surgical hub 206 using a uniquecompilation/string (e.g., ordered or random) of the unique identifiersassociated with the sub-components that combine to form the coupledcomponent. In one aspect, the component may initially encrypt the uniquecompilation/string of the coupled component using a public keyassociated with the surgical hub 206 and communicate the encryptedunique compilation/string to the surgical hub 206. In such an aspect,the surgical hub 206 would then decrypt the encrypted uniquecompilation/string using a private key (i.e., known only by the surgicalhub 206) paired to the public key used by the component to encrypt theunique compilation/string. Since the encrypted unique compilation/stringcan only be decrypted using the surgical hub's 206 private key and theprivate key is only known by the surgical hub 206, this is a secure wayto communicate a shared secret (e.g., the unique compilation/string ofthe coupled component) to the surgical hub 206. Further, in such anaspect, with a shared secret established, the component can encryptfuture communications to the surgical hub 206, and the surgical hub 206can decrypt the future communications from the component using theshared secret (e.g., the unique compilation/string of the coupledcomponent).

Again, asymmetric encryption algorithms may be complex and may requiresignificant computational resources to execute each communication. Assuch, establishing the unique compilation/string of the coupledcomponent (i.e., readily combinable by the component) as the sharedsecret is not only quicker (e.g., no need to generate a shared secretusing a pseudorandom key generator) but also increases computationalefficiency (e.g., enables the execution of faster, less complexsymmetric encryption algorithms) for all subsequent communications. Invarious aspects, this established shared secret may be utilized by thecomponent and surgical hub 206 until the component is decoupled from thesurgical hub 206 (e.g., surgical procedure ended). Furthermore, in suchan aspect, since various sub-components may be reusable (e.g., handle,shaft, end effector) while other sub-components may not be reusable(e.g., end effector, cartridge) each new combination of sub-componentsthat combine to form the coupled component provide a uniquecompilation/string usable as a shared secret for componentcommunications to the surgical hub 206.

According to further aspects of the present disclosure, components(e.g., surgical device/instrument 235, energy device 241, endoscope 239)of the surgical system 202 are associated with unique identifiers. Assuch, according to various aspects of the present disclosure, when acomponent is coupled to the surgical hub 206, the surgical hub 206 mayestablish a shared secret with a recipient (e.g., cloud-based system205) using the unique identifier of the coupled component. In oneaspect, the surgical hub 206 may initially encrypt the unique identifierof a coupled component using a public key associated with the recipientand communicate the encrypted unique identifier to the recipient. Insuch an aspect, the recipient would then decrypt the encrypted uniqueidentifier using a private key (i.e., known only by the recipient)paired to the public key used by the surgical hub 206 to encrypt theunique identifier. Since the encrypted unique identifier can only bedecrypted using the recipient's private key and the private key is onlyknown by the recipient, this is a secure way to communicate a sharedsecret (e.g., the unique identifier of the coupled component) to therecipient (e.g., cloud-based system). Further in such an aspect, with ashared secret established, the surgical hub 206 can encrypt futurecommunications to the recipient (e.g., cloud-based system 205), and therecipient can decrypt the future communications from the surgical hub206 using the shared secret (e.g., the unique identifier of the coupledcomponent).

Notably, asymmetric encryption algorithms may be complex and may requiresignificant computational resources to execute each communication. Assuch, establishing the unique identifier of the coupled component (i.e.,already available to the surgical hub 206) as the shared secret is notonly quicker (e.g., no need to generate a shared secret using apseudorandom key generator) but also increases computational efficiencyby, for example, enabling the execution of faster, less complexsymmetric encryption algorithms for all subsequent communications. Invarious aspects, this established shared secret may be utilized by thesurgical hub 206 until the component is decoupled from the surgical hub(e.g., surgical procedure ended).

According to yet further aspects of the present disclosure, components(e.g., surgical device/instrument 235, energy device 241, endoscope 239)of the surgical system 202 may comprise sub-components (e.g., handle,shaft, end effector, cartridge) each associated with its own uniqueidentifier. As such, according to various aspects of the presentdisclosure, when a component is coupled to the surgical hub 206, thesurgical hub 206 may establish a shared secret with a recipient (e.g.,cloud-based system 205) using a unique compilation/string (e.g., orderedor random) of the unique identifiers associated with the sub-componentsthat combine to form the coupled component.

In one aspect, the surgical hub 206 may initially encrypt the uniquecompilation/string of the coupled component using a public keyassociated with the recipient and communicate the encrypted uniquecompilation/string to the recipient. In such an aspect, the recipientwould then decrypt the encrypted unique compilation/string using aprivate key (i.e., known only by the recipient) paired to the public keyused by the surgical hub 206 to encrypt the unique compilation/string.Since the encrypted unique compilation/string can only be decryptedusing the recipient's private key and the private key is only known bythe recipient, this is a secure way to communicate a shared secret(e.g., the unique compilation/string of the coupled component) to therecipient. With a shared secret established, the surgical hub 206 canencrypt future communications to the recipient (e.g., cloud-based system205), and the recipient can decrypt the future communications from thesurgical hub 206 using the shared secret (e.g., the uniquecompilation/string of the coupled component). Again, asymmetricencryption algorithms may be complex and may require significantcomputational resources to execute each communication. As such,establishing the unique compilation/string of the coupled component(i.e., readily combinable by the surgical hub 206) as the shared secretis not only quicker (e.g., no need to generate a shared secret using apseudorandom key generator) but also increases computational efficiency(e.g., enables the execution of faster, less complex symmetricencryption algorithms) for all subsequent communications.

In various aspects, this established shared secret may be utilized bythe surgical hub 206 until the component is decoupled from the surgicalhub (e.g., surgical procedure ended). Furthermore, in such an aspect,since various sub-components may be reusable (e.g., handle, shaft, endeffector) while other sub-components may not be reusable (e.g., endeffector, cartridge) each new combination of sub-components that combineto form the coupled component provide a unique compilation/string usableas a shared secret for surgical hub 206 communications to the recipient.

In some aspects, an encrypt-then-MAC (EtM) approach may be utilized toproduce the encrypted generator data. An example of this approach isshown in FIG. 25, where the non-encrypted generator data (i.e., theplaintext 3742, e.g., data packet 3722) is first encrypted 3743 (e.g.,via key 3746) to produce a ciphertext 3744 (i.e., the encryptedgenerator data), then a MAC 3745 is produced based on the resultingciphertext 3744, the key 3746, and a MAC algorithm (e.g., a hashfunction 3747). More specifically, the ciphertext 3744 is processedthrough the MAC algorithm using the key 3746. In one aspect similar tosymmetric encryption discussed herein, the key 3746 is a secret keyaccessible/known by the surgical hub 206 and the recipient (e.g.,cloud-based system 205). In such an aspect, the secret key is a sharedsecret associated with/chosen by the surgical hub 206, a shared secretassociated with/chosen by the recipient, or a key selected via apseudorandom key generator. For this approach, as shown generally at3748, the encrypted generator data (i.e., the ciphertext 3744) and theMAC 3745 would be communicated together to the cloud-based system 205.

In other aspects, an encrypt-and-MAC (E&M) approach may be utilized toproduce the encrypted generator data. An example of this approach isshown in FIG. 26, where the MAC 3755 is produced based on thenon-encrypted generator data (i.e., the plaintext 3752, e.g., datapacket 3722), a key 3756, and a MAC algorithm (e.g., a hash function3757). More specifically, the plaintext 3752 is processed through theMAC algorithm using the key 3756. In one aspect similar to symmetricencryption discussed herein, the key 3756 is a secret keyaccessible/known by the surgical hub 206 and the recipient (e.g.,cloud-based system 205). In such an aspect, the secret key is a sharedsecret associated with/chosen by the surgical hub 206, a shared secretassociated with/chosen by the recipient, or a key selected via apseudorandom key generator. Further, in such an aspect, thenon-encrypted generator data (i.e., the plaintext 3752, e.g., datapacket 3722) is encrypted 3753 (e.g., via key 3756) to produce aciphertext 3754. For this approach, as shown generally at 3758, the MAC3755 (i.e., produced based on the non-encrypted generator data) and theencrypted generator data (i.e., the ciphertext 3754) would becommunicated together to the cloud-based system 205.

In yet other aspects, a MAC-then-encrypt (MtE) approach may be utilizedto produce the encrypted generator data. An example of this approach isshown in FIG. 27, where the MAC 3765 is produced based on thenon-encrypted generator data (i.e., the plaintext 3762), a key 3766, anda MAC algorithm (e.g., a hash function 3767). More specifically, theplaintext 3762 is processed through the MAC algorithm using the key3766. In one aspect similar to symmetric encryption discussed herein,the key 3766 is a secret key accessible/known by the surgical hub 206and the recipient (e.g., cloud-based system 205). In such an aspect, thesecret key is a shared secret associated with/chosen by the surgical hub206, a shared secret associated with/chosen by the recipient, or a keyselected via a pseudorandom key generator. Next, the non-encryptedgenerator data (i.e., the plaintext 3762) and the MAC 3765 are togetherencrypted 3763 (e.g., via key 3766) to produce a ciphertext 3764 basedon both. For this approach, as shown generally at 3768, the ciphertext3764 (i.e., which includes the encrypted generator data and theencrypted MAC 3765) would be communicated to the cloud-based system 205.

In alternative aspects, the key used to encrypt the non-encryptedgenerator data (e.g., FIG. 25 and FIG. 26) or the non-encryptedgenerator data and the MAC (e.g., FIG. 27) may be different from the key(e.g., keys 3746, 3756, 3766) used to produce the MAC. For example, thekey used to encrypt the non-encrypted generator data (e.g., FIG. 25 andFIG. 26) or the non-encrypted generator data and the MAC (e.g., FIG. 27)may be a different shared secret or a public key associated with therecipient.

In lieu of utilizing the MAC to provide for a subsequent assurance ofdata integrity to the cloud-based system 205, according to otheraspects, the surgical hub 206 can utilize a digital signature to allowthe cloud-based system 205 to subsequently authenticate integrity of thecommunicated generator data. For example, the processor module 232and/or the processor 244 of the computer system 210 can utilize one ormore algorithms to generate a digital signature associated with thegenerator data, and the cloud-based system 205 can utilize an algorithmto determine the authenticity of the received generator data. Thealgorithms utilized by the processor module 232 and/or the processor 244of the computer system 210 can include: (1) a key generation algorithmthat selects a private key uniformly at random from a set of possibleprivate keys, where the key generation algorithm outputs the private keyand a corresponding public key; and (2) a signing algorithm that, giventhe generator data and a private key, produces a digital signatureassociated with the generator data. The cloud-based system 205 canutilize a signature verifying algorithm that, given the receivedgenerator data, public key, and digital signature, can accept thereceived generator data as authentic if the digital signature isdetermined to be authentic or consider the generator data to becompromised or altered if the digital signature is not determined to beauthentic.

According to other aspects of the present disclosure, the surgical hub206 can utilize a commercial authentication program (e.g., Secure HashAlgorithm, SHA-2 comprising SHA-256) to provide for a subsequentassurance of data integrity of the communicated generator data to thecloud-based system 205.

After the generator data has been encrypted (e.g., via EtM, E&M, MtE), acomponent of the surgical hub 206 can communicate the encryptedgenerator data to the cloud-based system 205. The component of thesurgical hub 206 which communicates the encrypted generator data to thecloud-based system 205 can be, for example, the processor module 232, ahub/switch 207/209 of the modular communication hub 203, the router 211of the modular communication hub 203, the communication module 247 ofthe computer system 210, etc.

According to various aspects, the communication of the encryptedgenerator data through the Internet can follow an IP which: (1) definesdatagrams that encapsulate the encrypted generator data to be deliveredand/or (2) defines addressing methods that are used to label thedatagram with source and destination information. A high-levelrepresentation of an example datagram 3770 is shown in FIG. 28, wherethe datagram 3770 includes a header 3772 and a payload 3774, and inother aspects also may include a trailer (not shown). A more detailedrepresentation of an example datagram 3780 is shown in FIG. 29, wherethe header 3782 can include fields for information such as, for example,the IP address of the source 3786 which is sending the datagram (e.g.,the router 211 of the modular communication hub 203), the IP address ofthe destination 3788 which is to receive the datagram (e.g., the cloud204 and/or the remote server 213 associated with the cloud-based system205), a type of service designation (not shown), a header length 3790, apayload length 3792, and a checksum value 3794. In such an aspect, thesurgical hub 206 may further apply a checksum function/algorithm to thenon-encrypted generator data (i.e., the plaintext 3742, e.g., datapacket 3722) or at least a portion of the non-encrypted generator data(e.g., combination generator ID 3726) to derive the checksum value 3794.Here, the checksum function/algorithm is configured to output asignificantly different checksum value if there is any modification(e.g., even a slight change) to the underlying data (e.g., generatordata). After decryption of the encrypted generator data by its recipient(e.g., cloud-based system 205), the recipient may apply the samechecksum function/algorithm to the decrypted generator data to generatea validating checksum value. If the validating checksum value matchesthe checksum value 3794 (i.e., stored in the header 3782 of the receiveddatagram 3780), the integrity of the received generator data is furtherverified. The payload 3784 may include the encrypted generator data 3796and can also include padding 3798 if the encrypted generator data 3796is less than a specified payload length. Notably, the communicatedencrypted generator data 3796 may comprise a MAC as discussed in FIGS.25, 26, and 27 above (e.g., references 3748, 3758, and 3768,respectively). In some aspects, the header 3782 can further include aspecific path the datagram is to follow when the datagram iscommunicated from the surgical hub 206 to the cloud-based system 205(e.g., from IP address of the source, to IP address of at least oneintermediate network component (e.g., specified routers, specifiedservers), to IP address of the destination).

According to various aspects, prior to the generator data beingencrypted, the generator data can be time-stamped (if not alreadytime-stamped by the combination generator 3700) and/or the generatordata can be compressed (if not already compressed by the combinationgenerator 3700). Time-stamping allows for the cloud-based system 205 tocorrelate the generator data with other data (e.g., stripped patientdata) which may be communicated to the cloud-based system 205. Thecompression allows for a smaller representation of the generator data tobe subsequently encrypted and communicated to the cloud-based system205. For the compression, a component of the surgical hub 206 canutilize a compression algorithm to convert a representation of thegenerator data to a smaller representation of the generator data,thereby allowing for a more efficient and economical encryption of thegenerator data (e.g., less data to encrypt utilizes less processingresources) and a more efficient and economical communication of theencrypted generator data (e.g., smaller representations of the generatordata within the payload of the datagrams (e.g., FIGS. 28 and 29) allowfor more generator data to be included in a given datagram, for moregenerator data to be communicated within a given time period, and/or forgenerator data to be communicated with fewer communication resources).The component of the surgical hub 206 which utilizes/executes thecompression algorithm can be, for example, the processor module 232, theprocessor 244 of the computer system, and/or combinations thereof. Theutilized/executed compression algorithm can be a lossless compressionalgorithm or a lossy compression algorithm.

Once the generator data and the MAC for a given datagram has beenreceived at the cloud-based system 205 (e.g., FIG. 25, reference 3748;FIG. 26, reference 3758; and FIG. 27, reference 3768), the cloud-basedsystem 205 can decrypt the encrypted generator data from the payload ofthe communicated datagram to realize the communicated generator data.

In one aspect, referring back to FIG. 25, the recipient (e.g.,cloud-based system 205) may, similar to the surgical hub 206, processthe ciphertext 3744 through the same MAC algorithm using the sameknown/accessible secret key to produce an authenticating MAC. If thereceived MAC 3745 matches this authenticating MAC, the recipient (e.g.,cloud-based system 205) may safely assume that the ciphertext 3744 hasnot been altered and is from the surgical hub 206. The recipient (e.g.,cloud-based system 205) may then decrypt the ciphertext 3744 (e.g., viakey 3746) to realize the plaintext 3742 (e.g., data packet comprisinggenerator data).

In another aspect, referring back to FIG. 26, the recipient (e.g.,cloud-based system 205) may decrypt the ciphertext 3754 (e.g., via key3756) to realize the plaintext 3752 (e.g., data packet comprisinggenerator data). Next, similar to the surgical hub 206, the recipient(e.g., cloud-based system 205) may process the plaintext 3752 throughthe same MAC algorithm using the same known/accessible secret key toproduce an authenticating MAC. If the received MAC 3755 matches thisauthenticating MAC, the recipient (e.g., cloud-based system 205) maysafely assume that the plaintext 3752 has not been altered and is fromthe surgical hub 206.

In yet another aspect, referring back to FIG. 27, the recipient (e.g.,cloud-based system 205) may decrypt the ciphertext 3764 (e.g., via key3766) to realize the plaintext 3762 (e.g., data packet comprisinggenerator data) and the MAC 3765. Next, similar to the surgical hub 206,the recipient (e.g., cloud-based system 205) may process the plaintext3762 through the same MAC algorithm using the same known/accessiblesecret key to produce an authenticating MAC. If the received MAC 3765matches this authenticating MAC, the recipient (e.g., cloud-based system205) may safely assume that the plaintext 3762 has not been altered andis from the surgical hub 206.

In alternative aspects, the key used to encrypt the non-encryptedgenerator data (e.g., FIG. 25 and FIG. 26) or the non-encryptedgenerator data and the MAC (e.g., FIG. 27) may be different from the key(e.g., keys 3746, 3756, 3766) used to produce the MAC. For example, thekey used to encrypt the non-encrypted generator data (e.g., FIG. 25 andFIG. 26) or the non-encrypted generator data and the MAC (e.g., FIG. 27)may be a different shared secret or a public key associated with therecipient. In such aspects, referring to FIG. 25, the recipient (e.g.,cloud-based system 205) may, after verifying the authenticating MAC viakey 3746 (described above), then decrypt the ciphertext 3744 (e.g., viathe different shared secret or private key associated with therecipient) to realize the plaintext 3742 (e.g., data packet comprisinggenerator data). In such aspects, referring to FIG. 26, the recipientmay decrypt the ciphertext 3754 (e.g., via the different shared secretor private key associated with the recipient) to realize the plaintext3752 (e.g., data packet comprising generator data), then verify theauthenticating MAC via key 3756 (described above). In such aspects,referring to FIG. 27, the recipient may decrypt the ciphertext 3764(e.g., via the different shared secret or private key associated withthe recipient) to realize the plaintext 3762 (e.g., data packetcomprising generator data) and the MAC 3765, then verify theauthenticating MAC via key 3766 (described above).

In sum, referring to FIGS. 25-27, if an authenticating MAC, asdetermined/calculated by the cloud-based system 205, is the same as theMAC which was received with the datagram, the cloud-based system 205 canhave confidence that the received generator data is authentic (i.e., itis the same as the generator data which was communicated by the surgicalhub 206) and that the data integrity of the communicated generator datahas not been compromised or altered. As described above, the recipientmay further apply the plaintext 3742, 3752, 3762, or at least a portionthereof to the same checksum function/algorithm (i.e., used by thesurgical hub 206) to generate a validating checksum value to furtherverify the integrity of the generator data based on the checksum valuestored in the header of the communicated datagram.

Additionally, based on the decrypted datagram, the IP address of thesource (e.g., FIG. 29, reference 3786) which originally communicated thedatagram to the cloud-based system 205 can be determined from the headerof the communicated datagram. If the determined source is a recognizedsource, the cloud-based system 205 can have confidence that thegenerator data originated from a trusted source, thereby providingsource authentication and even more assurance of the data integrity ofthe generator data. Furthermore, since each router the datagram passedthrough in route to the cloud-based system 205 includes its IP addresswith its forwarded communication, the cloud-based system 205 is able totrace back the path followed by the datagram and identify each routerwhich handled the datagram. The ability to identify the respectiverouters can be helpful in instances where the content of the datagramreceived at the cloud-based system 205 is not the same as the content ofthe datagram as originally communicated by the surgical hub 206. Foraspects where the communication path was pre-specified and included inthe header of the communicated datagram, the ability to identify therespective routers can allow for path validation and provide additionalconfidence of the authenticity of the received generator data.

Furthermore, according to various aspects, after authenticating thereceived generator data, the cloud-based system 205 can communicate amessage (e.g., a handshake or similar message) to the surgical hub 206via the Internet or another communication network,confirming/guaranteeing that the datagram communicated from the surgicalhub 206 was received intact by the cloud-based system 205, therebyeffectively closing the loop for that particular datagram.

Aspects of the above-described communication method, and/or variationsthereof, can also be employed to communicate data other than generatordata to the cloud-based system 205 and/or to communicate generator dataand/or other data from the surgical hub 206 to systems and/or devicesother than the cloud-based system 205. For example, according to variousaspects, the generator data and/or other data can be communicated fromthe surgical hub 206 to a hand-held surgical device/instrument (e.g.,wireless device/instrument 235), to a robotic interface of a surgicaldevice/instrument (e.g., robot hub 222) and/or to other servers,including servers (e.g., similar to server 213) associated with othercloud-based systems (e.g., similar to cloud-based system 205) inaccordance with the above-described communication method. For example,in certain instances, an EEPROM chip of a given surgical instrument caninitially be provided with merely an electronic chip device ID. Uponconnection of the given surgical instrument to the combination generator3700, data can be downloaded from the cloud-based system 205 to thesurgical hub 206 and subsequently to the EEPROM of the surgicalinstrument in accordance with the above-described communication method.

In addition to communicating generator data to the cloud-based system205, the surgical hub 206 can also utilize the above-described method ofcommunication, and/or variations thereof, to communicate data other thangenerator data to the cloud-based system 205. For example, the surgicalhub 206 can also communicate other information associated with thesurgical procedure to the cloud-based system 205. Such other informationcan include, for example, the type of surgical procedure beingperformed, the name of the facility where the surgical procedure isbeing performed, the location of the facility where the surgicalprocedure is being performed, an identification of the operating roomwithin the facility where the surgical procedure is being performed, thename of the surgeon performing the surgical procedure, the age of thepatient, and data associated with the condition of the patient (e.g.,blood pressure, heart rate, current medications). According to variousaspects, such other information may be stripped of all information whichcould identify the specific surgery, the patient, or the surgeon, sothat the information is essentially anonymized for further processingand analysis by the cloud-based system 205. In other words, the strippeddata is not correlated to a specific surgery, patient, or surgeon. Thestripped information can be communicated to the cloud-based system 205either together with or distinct from the communicated generator data.

For instances where the stripped/other data is to be communicated apartfrom the generator data, the stripped/other data can be time-stamped,compressed, and/or encrypted in a manner identical to or different fromthat described above regarding the generator data, and the surgical hub206 may be programmed/configured to generate a datagram which includesthe encrypted stripped/other information in lieu of the encryptedgenerator data. The datagram can then be communicated from the surgicalhub 206 through the Internet to the cloud-based system 205 following anIP which: (1) defines datagrams that encapsulate the encryptedstripped/other data to be delivered, and (2) defines addressing methodsthat are used to label the datagram with source and destinationinformation.

For instances where the stripped/other information is to be communicatedwith the generator data, the stripped/other data can be time-stamped,compressed, and/or encrypted in a manner identical to or different fromthat described above regarding the generator data, and the surgical hub206 may be programmed/configured to generate a datagram which includesboth the encrypted generator data and the encrypted stripped/otherinformation. An example of such a datagram in shown in FIG. 30, wherethe payload 3804 of the datagram 3800 is divided into two or moredistinct payload data portions (e.g., one for the encrypted generatordata 3834, one for the encrypted stripped/other information 3836), witheach portion having an identifying bit (e.g., generator data (GD) 3806,other data (OD) 3812), the associated encrypted data 3808, 3814, and theassociated padding 3810, 3816, if needed, respectively. Further, asshown in FIG. 30, the header 3802 may be the same as (e.g., IP addresssource 3818, IP address destination 3820, header length 3822) ordifferent from the header 3782 described with reference to the datagram3780 shown in FIG. 29. For example, the header 3802 may be different inthat the header 3802 further includes a field designating the number ofpayload data portions 3824 (e.g., 2) included in the payload 3804 of thedatagram 3800. The header 3802 can also be different in that it caninclude fields designating the payload length 3826, 3830 and thechecksum value 3828, 2832 for each payload data portion 3834, 3836,respectively. Although only two payload data portions are shown in FIG.30, it will be appreciated that the payload 3804 of the datagram 3800may include any quantity/number of payload data portions (e.g., 1, 2, 3,4, 5), where each payload data portion includes data associated with adifferent aspect of the surgical procedure. The datagram 3800 can thenbe communicated from the surgical hub 206 through the Internet to thecloud-based system 205 following an IP which: (1) defines datagrams thatencapsulate the encrypted generator data and the encryptedstripped/other data to be delivered, and (2) defines addressing methodsthat are used to label the datagram with source and destinationinformation.

As set forth above, it is an unfortunate reality that the outcomes ofall surgical procedures are not always optimal and/or successful. Forinstances where a failure event is detected and/or identified, avariation of the above-described communication methods can be utilizedto isolate surgical data which is associated with the failure event(e.g., failure event surgical data) from surgical data which is notassociated with the failure event (e.g., non-failure event surgicaldata) and communicate the surgical data which is associated with thefailure event (e.g., failure event data) from the surgical hub 206 tothe cloud-based system 205 on a prioritized basis for analysis.According to one aspect of the present disclosure, failure eventsurgical data is communicated from the surgical hub 206 to thecloud-based system 205 on a prioritized basis relative to non-failureevent surgical data.

FIG. 31 illustrates various aspects of a system-implemented method ofidentifying surgical data associated with a failure event (e.g., failureevent surgical data) and communicating the identified surgical data to acloud-based system 205 on a prioritized basis. The method comprises (1)receiving 3838 surgical data at a surgical hub 206, wherein the surgicaldata is associated with a surgical procedure; (2) time-stamping 3840 thesurgical data; (3) identifying 3842 a failure event associated with thesurgical procedure; (4) determining 3844 which of the surgical data isassociated with the failure event (e.g., failure event surgical data);(5) separating 3846 the surgical data associated with the failure eventfrom all other surgical data (e.g., non-failure event surgical data)received at the surgical hub 206; (6) chronologizing 3848 the surgicaldata associated with the failure event; (7) encrypting 3850 the surgicaldata associated with the failure event; and (8) communicating 3852 theencrypted surgical data to a cloud-based system 205 on a prioritizedbasis.

More specifically, various surgical data can be captured during asurgical procedure and the captured surgical data, as well as othersurgical data associated with the surgical procedure, can becommunicated to the surgical hub 206. The surgical data can include, forexample, data associated with a surgical device/instrument (e.g., FIG.9, surgical device/instrument 235) utilized during the surgery, dataassociated with the patient, data associated with the facility where thesurgical procedure was performed, and data associated with the surgeon.Either prior to or subsequent to the surgical data being communicated toand received by the surgical hub 206, the surgical data can betime-stamped and/or stripped of all information which could identify thespecific surgery, the patient, or the surgeon, so that the informationis essentially anonymized for further processing and analysis by thecloud-based system 205.

Once a failure event has been detected and/or identified (e.g., whichcan be either during or after the surgical procedure), the surgical hub206 can determine which of the surgical data is associated with thefailure event (e.g., failure event surgical data) and which of thesurgical data is not associated with the surgical event (e.g.,non-failure event surgical data). According to one aspect of the presentdisclosure, a failure event can include, for example, a detection of oneor more misfired staples during a stapling portion of a surgicalprocedure. For example, in one aspect, referring to FIG. 9, an endoscope239 may take snapshots while a surgical device/instrument 235 comprisingan end effector including a staple cartridge performs a stapling portionof a surgical procedure. In such an aspect, an imaging module 238 maycompare the snapshots to stored images and/or images downloaded from thecloud-based system 205 that convey correctly fired staples to detect amisfired staple and/or evidence of a misfired staple (e.g., a leak). Inanother aspect, the imaging module 238 may analyze the snapshotsthemselves to detect a misfired staple and/or evidence of a misfiredstaple. In one alternative aspect, the surgical hub 206 may communicatethe snapshots to the cloud-based system 205, and a component of thecloud-based system 205 may perform the various imaging module functionsdescribed above to detect a misfired staple and/or evidence of amisfired staple and to report the detection to the surgical hub 206.According to another aspect of the present disclosure, a failure eventcan include a detection of a tissue temperature which is below theexpected temperature during a tissue-sealing portion of a surgicalprocedure and/or a visual indication of excessive bleeding or oozingfollowing a surgical procedure (e.g., FIG. 9, via endoscope 239). Forexample, in one aspect, referring to FIG. 9, the surgicaldevice/instrument 235 may comprise an end effector, including atemperature sensor and the surgical hub 206, and/or the cloud-basedsystem may compare at least one temperature detected by the temperaturesensor (e.g., during a tissue-sealing portion of a surgical procedure)to a stored temperature and/or a range of temperatures expected and/orassociated with that surgical procedure to detect an inadequate/lowsealing temperature. In another aspect, an endoscope 239 may takesnapshots during a surgical procedure. In such an aspect, an imagingmodule 238 may compare the snapshots to stored images and/or imagesdownloaded from the cloud-based system 205 that convey tissue correctlysealed at expected temperatures to detect evidence of animproper/insufficient sealing temperature (e.g., charring,oozing/bleeding). Further, in such an aspect, the imaging module 238 mayanalyze the snapshots themselves to detect evidence of animproper/insufficient sealing temperature (e.g., charring,oozing/bleeding). In one alternative aspect, the surgical hub 206 maycommunicate the snapshots to the cloud-based system 205, and a componentof the cloud-based system 205 may perform the various imaging modulefunctions described above to detect evidence of an improper/insufficientsealing temperature and to report the detection to the surgical hub 206.According to the various aspects described above, in response to thedetected and/or identified failure event, the surgical hub 206 maydownload a program from the cloud-based system 205 for execution by thesurgical device/instrument 235 that corrects the detected issue (i.e.,program that alters surgical device/instrument parameters to preventmisfired staples, program that alters surgical device/instrumentparameters to ensure correct sealing temperature).

In some aspects, a failure event is deemed to cover a certain timeperiod, and all surgical data associated with that certain time periodcan be deemed to be associated with the failure event.

After the surgical data associated with the failure event has beenidentified, the identified surgical data (e.g., failure event surgicaldata) can be separated or isolated from all of the other surgical dataassociated with the surgical procedure (e.g., non-failure event surgicaldata). The separation can be realized, for example, by tagging orflagging the identified surgical data, by storing the identifiedsurgical data apart from all of the other surgical data associated withthe surgical procedure, or by storing only the other surgical data whilecontinuing to process the identified surgical data for subsequentprioritized communication to the cloud-based system 205. According tovarious aspects, the tagging or flagging of the identified surgical datacan occur during the communication process when the datagram isgenerated as described in more detail below.

The time-stamping of all of the surgical data (e.g., either before orafter the surgical data is received at the surgical hub) can be utilizedby a component of the surgical hub 206 to chronologize the identifiedsurgical data associated with the failure event. The component of thesurgical hub 206 which utilizes the time-stamping to chronologize theidentified surgical data can be, for example, the processor module 232,the processor 244 of the computer system 210, and/or combinationsthereof. By chronologizing the identified surgical data, the cloud-basedsystem 205 and/or other interested parties can subsequently betterunderstand the conditions which were present leading up to theoccurrence of the failure event and possibly pinpoint the exact cause ofthe failure event, thereby providing the knowledge to potentiallymitigate a similar failure event from occurring during a similarsurgical procedure performed at a future date.

Once the identified surgical data has been chronologized, thechronologized surgical data may be encrypted in a manner similar to thatdescribed above with respect to the encryption of the generator data.Thus, the identified surgical data can be encrypted to help ensure theconfidentiality of the identified surgical data, either while it isbeing stored at the surgical hub 206 or while it is being transmitted tothe cloud-based system 205 using the Internet or other computernetworks. According to various aspects, a component of the surgical hub206 utilizes an encryption algorithm to convert the identified surgicaldata from a readable version to an encoded version, thereby forming theencrypted surgical data associated with the failure event (e.g., FIGS.25-27). The component of the surgical hub which utilizes the encryptionalgorithm can be, for example, the processor module 232, the processor244 of the computer system 210, and/or combinations thereof. Theutilized encryption algorithm can be a symmetric encryption algorithm oran asymmetric encryption algorithm.

After the identified surgical data has been encrypted, a component ofthe surgical hub can communicate the encrypted surgical data associatedwith the failure event (e.g., encrypted failure event surgical data) tothe cloud-based system 205. The component of the surgical hub whichcommunicates the encrypted surgical data to the cloud-based system 205can be, for example, the processor module 232, a hub/switch 207/209 ofthe modular communication hub 203, the router 211 of the modularcommunication hub 203, or the communication module 247 of the computersystem 210. According to various aspects, the communication of theencrypted surgical data (e.g., encrypted failure event surgical data)through the Internet can follow an IP which: (1) defines datagrams thatencapsulate the encrypted surgical data to be delivered, and (2) definesaddressing methods that are used to label the datagram with source anddestination information. The datagram can be similar to the datagramshown in FIG. 29 or the datagram shown in FIG. 30, but can be differentin that either the header or the payload of the datagram can include afield which includes a flag or a tag which identifies the encryptedsurgical data (e.g., encrypted failure event surgical data) as beingprioritized relative to other non-prioritized surgical data (e.g.,encrypted non-failure event surgical data). An example of such adatagram is shown in FIG. 32, where the payload 3864 of the datagram3860 includes a field which indicates (e.g., a prioritized designation3834) that the payload 3864 includes prioritized surgical data (e.g.,combination generator data 3868). According to various aspects, thepayload 3864 of the datagram 3860 can also includenon-flagged/non-tagged/non-prioritized surgical data 3836 (e.g., othersurgical data 3874) as shown in FIG. 32.

According to various aspects, prior to the identified surgical data(e.g., failure event surgical data) being encrypted, the identifiedsurgical data can be compressed (if not already compressed by thesource(s) of the relevant surgical data). The compression allows for asmaller representation of the surgical data associated with the failureevent to be subsequently encrypted and communicated to the cloud-basedsystem 205. For the compression, a component of the surgical hub 206 canutilize a compression algorithm to convert a representation of theidentified surgical data to a smaller representation of the identifiedsurgical data, thereby allowing for a more efficient and economicalencryption of the identified surgical data (less data to encryptutilizes less processing resources) and a more efficient and economicalcommunication of the encrypted surgical data (smaller representations ofthe surgical data within the payload of the datagrams allow for moreidentified surgical data to be included in a given datagram, for moreidentified surgical data to be communicated within a given time period,and/or for identified surgical data to be communicated with fewercommunication resources). The component of the surgical hub 206 whichutilizes the compression algorithm can be, for example, the processormodule 232, the processor 244 of the computer system 210, and/orcombinations thereof. The utilized compression algorithm can be alossless compression algorithm or a lossy compression algorithm.

In instances where other non-prioritized surgical data (e.g.,non-failure event surgical data) is to be communicated with prioritizedsurgical data (e.g., failure event surgical data), the othernon-prioritized surgical data can be time-stamped, compressed, and/orencrypted in a manner identical to or different from that describedabove regarding the surgical data identified as associated with afailure event (e.g., failure event surgical data), and the surgical hub206 may be programmed/configured to generate a datagram which includesboth the encrypted prioritized surgical data (e.g., encrypted failureevent surgical data) and the encrypted other non-prioritized surgicaldata (e.g., encrypted non-failure event surgical data). For example, inlight of FIG. 32, the payload 3864 of the datagram 3860 may be dividedinto two or more distinct payload data portions (e.g., one for theprioritized surgical data 3834, one for the non-prioritized surgicaldata 3836), with each portion having an identifying bit (e.g., generatordata (GD) 3866, other data (OD) 3872), the associated encrypted data(e.g., encrypted prioritized surgical data 3868, encryptednon-prioritized surgical data 3874), and the associated padding 3870,3876, if needed, respectively. Further, similar to FIG. 30, the header3862 may be the same as (e.g., IP address source 3878, IP addressdestination 3880, header length 3882) or different from the header 3782described with reference to the datagram 3780 shown in FIG. 29. Forexample, the header 3862 may be different in that the header 3862further includes a field designating the number of payload data portions3884 (e.g., 2) included in the payload 3864 of the datagram 3860. Theheader 3862 can also be different in that it can include fieldsdesignating the payload length 3886, 3890 and the checksum value 3888,2892 for each payload data portion 3834, 3836, respectively. Althoughonly two payload data portions are shown in FIG. 32, it will beappreciated that the payload 3864 of the datagram 3860 may include anyquantity/number of payload data portions (e.g., 1, 2, 3, 4, 5), whereeach payload data portion includes data associated with a differentaspect of the surgical procedure. The datagram 3860 can then becommunicated from the surgical hub 206 through the Internet to thecloud-based system 205 following an IP which: (1) defines datagrams thatencapsulate the encrypted generator data and the encryptedstripped/other data to be delivered, and (2) defines addressing methodsthat are used to label the datagram with source and destinationinformation.

In some aspects, once a failure event associated with a surgicalprocedure has been identified, the surgical hub 206 and/or thecloud-based system 205 can subsequently flag or tag a surgicaldevice/instrument 235 which was utilized during the surgical procedurefor inoperability and/or removal. For example, in one aspect,information (e.g., serial number, ID) associated with the surgicaldevice/instrument 235 and stored at the surgical hub 206 and/or thecloud-based system 205 can be utilized to effectively block the surgicaldevice/instrument 235 from being used again (e.g., blacklisted). Inanother aspect, information (e.g., serial number, ID) associated withthe surgical device/instrument can initiate the printing of a shippingslip and shipping instructions for returning the surgicaldevice/instrument 235 back to a manufacturer or other designated partyso that a thorough analysis/inspection of the surgical device/instrument235 can be performed (e.g., to determine the cause of the failure).According to various aspects described herein, once the cause of afailure is determined (e.g., via the surgical hub 206 and/or thecloud-based system 205), the surgical hub 206 may download a programfrom the cloud-based system 205 for execution by the surgicaldevice/instrument 235 that corrects the determined cause of the failure(i.e., program that alters surgical device/instrument parameters toprevent the failure from occurring again).

According to some aspects, the surgical hub 206 and/or the cloud-basedsystem 205 can also provide/display a reminder (e.g., via hub display215 and/or surgical device/instrument display 237) to administrators,staff, and/or other personnel to physically remove the surgicaldevice/instrument 235 from the operating room (e.g., if detected asstill present in the operating room) and/or to send the surgicaldevice/instrument 235 to the manufacturer or the other designated party.In one aspect, the reminder may be set up to be provided/displayedperiodically until an administrator can remove the flag or tag of thesurgical device/instrument 235 from the surgical hub 206 and/or thecloud-based system 205. According to various aspects, an administratormay remove the flag or tag once the administrator can confirm (e.g.,system tracking of the surgical device/instrument 235 via its serialnumber/ID) that the surgical device/instrument 235 has been received bythe manufacturer or the other designated party. By using theabove-described method to flag and/or track surgical data associatedwith a failure event, a closed loop control of the surgical dataassociated with the failure event and/or with a surgicaldevice/instrument 235 can be realized. Additionally, in view of theabove, it will be appreciated that the surgical hub 206 can be utilizedto effectively manage the utilization (or non-utilization) of surgicaldevices/instruments 235 which have or potentially could be utilizedduring a surgical procedure.

In various aspects of the present disclosure, the surgical hub 206and/or cloud-based system 205 may want to control which components(e.g., surgical device/instrument 235, energy device 241) are beingutilized in its interactive surgical system 100/200 to perform surgicalprocedures (e.g., to minimize future failure events, to avoid the use ofunauthorized or knock-off components).

As such, in various aspects of the present disclosure, since aninteractive surgical system 100 may comprise a plurality of surgicalhubs 106, a cloud-based system 105 and/or each surgical hub 106 of theinteractive surgical system 100 may want to track component-surgical hubcombinations utilized over time. In one aspect, upon/after a component(See FIG. 9, e.g., surgical device/instrument 235, energy device 241) isconnected to/used with a particular surgical hub 106 (e.g., surgicaldevice/instrument 235 wired/wirelessly connected to the particularsurgical hub 106, energy device 241 connected to the particular surgicalhub 106 via generator module 240), the particular surgical hub 106 maycommunicate a record/block of that connection/use (e.g., linkingrespective unique identifiers of the connected devices) to thecloud-based system 105 and/or to the other surgical hubs 106 in theinteractive surgical system 100. For example, upon/after theconnection/use of an energy device 241, a particular surgical hub 106may communicate a record/block (e.g., linking a unique identifier of theenergy device 241 to a unique identifier of a generator module 240 to aunique identifier of the particular surgical hub 106) to the cloud-basedsystem 105 and/or other surgical hubs 106 in the interactive surgicalsystem 100. In such an aspect, if this is the first time the component(e.g., energy device) is connected to/used with a surgical hub 106 inthe interactive surgical system 100, the cloud-based system 105 and/oreach surgical hub 106 of the interactive surgical system 100 may storethe record/block as a genesis record/block. In such an aspect, thegenesis record/block stored at the cloud-based system 105 and/or eachsurgical hub 106 may comprise a time stamp. However, in such an aspect,if this is not the first time the component (e.g., energy device 241)has been connected to/used with a surgical hub 106 in the interactivesurgical system 100, the cloud-based system 105 and/or each surgical hub106 of the interactive surgical system may store the record/block as anew record/block in a chain of record/blocks associated with thecomponent. In such an aspect, the new record/block may comprise acryptographic hash of the most recently communicated record/block storedat the cloud-based system 105 and/or each surgical hub 106, thecommunicated linkage data, and a time stamp. In such an aspect, eachcryptographic hash links each new record/block (e.g., each use of thecomponent) to its prior record/block to form a chain confirming theintegrity of each prior record/block(s) back to an original genesisrecord/block (e.g., first use of the component). According to such anaspect, this blockchain of records/blocks may be developed at thecloud-based system 105 and/or each surgical hub 106 of the interactivesurgical system 100 to permanently and verifiably tie usage of aparticular component to one or more than one surgical hub 106 in theinteractive surgical system 100 over time. Here, according to anotheraspect, this approach may be similarly applied to sub-components (e.g.,handle, shaft, end effector, cartridge) of a component when/after thecomponent is connected to/used with a particular surgical hub 106 of aninteractive surgical system 100.

According to various aspects of the present disclosure, the cloud-basedsystem 105 and/or each surgical hub 106 may utilize such records/blocksto trace usage of a particular component and/or a sub-component back toits initial usage in the interactive surgical system 100. For example,if a particular component (e.g., surgical device/instrument 235) isflagged/tagged as related to a failure event, the cloud-based system 105and/or a surgical hub 106 may analyze such records/blocks to determinewhether past usage of that component and/or a sub-component of thatcomponent contributed to or caused the failure event (e.g., overused).In one example, the cloud-based system 105 may determine that asub-component (e.g., end effector) of that component may actually becontributing/causing the failure event and then tag/flag that componentfor inoperability and/or removal based on the determination.

According to another aspect, the cloud-based system 205 and/or surgicalhub 206 may control which components (e.g., surgical device/instrument235, energy device 241) are being utilized in an interactive surgicalsystem 200 to perform surgical procedures by authenticating thecomponent and/or its supplier/manufacturer. In one aspect, thesupplier/manufacturer of a component may associate a serial number and asource ID with the component. In such an aspect, thesupplier/manufacturer may create/generate a private key for the serialnumber, encrypt the serial number with the private key, and store theencrypted serial number and the source ID on an electronic chip (e.g.,memory) in the component prior to shipment to a surgical site. Here,upon/after connection of the component to a surgical hub 206, thesurgical hub 206 may read the encrypted serial number and the source IDfrom the electronic chip. In response, the surgical hub 206 may send amessage (i.e., comprising the encrypted serial number) to a server ofthe supplier/manufacturer associated with the source ID (e.g., directlyor via the cloud-based system 205). In such an aspect, the surgical hub206 may encrypt the message using a public key associated with thatsupplier/manufacturer. In response, the surgical hub 206 may receive amessage (i.e., comprising the private key the supplier/manufacturergenerated for/associated with that encrypted serial number) from thesupplier/manufacturer server (e.g., directly or via the cloud-basedsystem 205). In such an aspect, the supplier/manufacturer server mayencrypt the message using a public key associated with the surgical hub206. Further, in such an aspect, the surgical hub 206 may then decryptthe message (e.g., using a private key paired to the public key used toencrypt the message) to reveal the private key associated with theencrypted serial number. The surgical hub 206 may then decrypt theencrypted serial number, using that private key, to reveal the serialnumber. Further, in such an aspect, the surgical hub 206 may thencompare the decrypted serial number to a comprehensive list ofauthorized serial numbers (e.g., stored at the surgical hub 206 and/orthe cloud-based system and/or downloaded from the cloud-based system,e.g., received separately from the supplier/manufacturer) and permit useof the connected component if the decrypted serial number matches anauthorized serial number. Initially, such a process permits the surgicalhub 206 to authenticate the supplier/manufacturer. In particular, thesurgical hub 206 encrypted the message comprising the encrypted serialnumber using a public key associated with the supplier/manufacturer. Assuch, receiving a response message (i.e., comprising the private key)authenticates the supplier/manufacturer to the surgical hub 206 (i.e.,otherwise the supplier/manufacturer would not have access to the privatekey paired to the public key used by the surgical hub 206 to encrypt themessage, and the supplier/manufacturer would not have been able toassociate the encrypted serial number received in the message to itsalready generated private key). Furthermore, such a process permits thesurgical hub 206 to authenticate the connected component/device itself.In particular, the supplier/manufacturer (e.g., just authenticated)encrypted the serial number of the component using the delivered privatekey. Upon secure receipt of the private key, the surgical hub 206 isable to decrypt the encrypted serial number (i.e., read from theconnected component), which authenticates the component and/or itsassociation with the supplier/manufacturer (i.e., only that private keyas received from that supplier/manufacturer would decrypt the encryptedserial number). Nonetheless, the surgical hub 206 further verifies thecomponent as authentic (e.g., compares the decrypted serial number to acomprehensive list of authorized serial numbers received separately fromthe supplier/manufacturer). Notably, such aspects as described above canalternatively be performed by the cloud-based system 205 and/or acombination of the cloud-based system 205 and the surgical hub 206 tocontrol which components (e.g., surgical device/instrument 235, energydevice 241) are being utilized in an interactive surgical system 200(e.g., to perform surgical procedures) by authenticating the componentand/or its supplier/manufacturer. In one aspect, such describedapproaches may prevent the use of knock-off component(s) within theinteractive surgical system 200 and ensure the safety and well-being ofsurgical patients.

According to another aspect, the electronic chip of a component (e.g.,surgical device/instrument 235, energy device 241) may store (e.g., inmemory) data associated with usage of that component (i.e., usage data,e.g., number of uses with a limited use device, number of usesremaining, firing algorithms executed, designation as a single-usecomponent). In such an aspect, the surgical hub 206 and/or thecloud-based system 205, upon/after connection of the component to theinteractive surgical system, may read such usage data from the memory ofa component and write back at least a portion of that usage data forstorage (e.g., in memory 249) at the surgical hub 206 and/or for storageat the cloud-based system 205 (e.g., individually and/or under ablockchain approach discussed herein). According to such an aspect, thesurgical hub 206 and/or the cloud-based system 205, upon/after asubsequent connection of that component to the interactive surgicalsystem, may again read such usage data and compare that usage topreviously stored usage data. Here, if a discrepancy exists or if apredetermined/authorized usage has been met, the surgical hub 206 and/orthe cloud-based system 205 may prevent use of that component (e.g.,blacklisted, rendered inoperable, flagged for removal) on theinteractive surgical system 200. In various aspects, such an approachprevents bypass of the encryption chip systems. If the component'selectronic chip/memory has been tampered with (e.g., memory reset,number of uses altered, firing algorithms altered, single-use devicedesignated as a multi-use device), a discrepancy will exist, and thecomponent's use will be controlled/prevented.

Additional details are disclosed in U.S. Patent Application PublicationNo. 2017/0086914, titled TECHNIQUES FOR OPERATING GENERATOR FORDIGITALLY GENERATING ELECTRICAL SIGNAL WAVEFORMS AND SURGICALINSTRUMENTS, which published on Mar. 30, 2017, which is incorporatedherein by reference in its entirety.

Surgical Hub Coordination of Device Pairing in an Operating Room

One of the functions of the surgical hub 106 is to pair (also referredto herein as “connect” or “couple”) with other components of thesurgical system 102 to control, gather information from, or coordinateinteractions between the components of the surgical system 102. Sincethe operating rooms of a hospital are likely in close physical proximityto one another, a surgical hub 106 of a surgical system 102 mayunknowingly pair with components of a surgical system 102 in aneighboring operating room, which would significantly interfere with thefunctions of the surgical hub 106. For example, the surgical hub 106 mayunintentionally activate a surgical instrument in a different operatingroom or record information from a different ongoing surgical procedurein a neighboring operating room.

Aspects of the present disclosure present a solution, wherein a surgicalhub 106 only pairs with detected devices of the surgical system 102 thatare located within the bounds of its operating room.

Furthermore, the surgical hub 106 relies on its knowledge of thelocation of other components of the surgical system 102 within itsoperating room in making decisions about, for example, which surgicalinstruments should be paired with one another or activated. A change inthe position of the surgical hub 106 or another component of thesurgical system 102 can be problematic.

Aspects of the present disclosure further present a solution wherein thesurgical hub 106 is configured to reevaluate or redetermine the boundsof its operating room upon detecting that the surgical hub 106 has beenmoved. Aspects of the present disclosure further present a solutionwherein the surgical hub 106 is configured to redetermine the bounds ofits operating room upon detection of a potential device of the surgicalsystem 102, which can be an indication that the surgical hub 106 hasbeen moved.

In various aspects, a surgical hub 106 is used with a surgical system102 in a surgical procedure performed in an operating room. The surgicalhub 106 comprises a control circuit configured to determine the boundsof the operating room, determine devices of the surgical system 102located within the bounds of the operating room, and pair the surgicalhub 106 with the devices of the surgical system 102 located within thebounds of the operating room.

In one aspect, the control circuit is configured to determine the boundsof the operating room after activation of the surgical hub 106. In oneaspect, the surgical hub 106 includes a communication circuit configuredto detect and pair with the devices of the surgical system locatedwithin the bounds of the operating room. In one aspect, the controlcircuit is configured to redetermine the bounds of the operating roomafter a potential device of the surgical system 102 is detected. In oneaspect, the control circuit is configured to periodically determine thebounds of the operating room.

In one aspect, the surgical hub 106 comprises an operating room mappingcircuit that includes a plurality of non-contact sensors configured tomeasure the bounds of the operating room.

In various aspects, the surgical hub 106 includes a processor and amemory coupled to the processor. The memory stores instructionsexecutable by the processor to pair the surgical hub with devices of thesurgical system 102 located within the bounds of the operating room, asdescribed above. In various aspects, the present disclosure provides anon-transitory computer-readable medium storing computer-readableinstructions which, when executed, cause a machine to pair the surgicalhub 106 with devices of the surgical system 102 located within thebounds of the operating room, as described above.

FIGS. 35 and 36 are logic flow diagrams of processes depicting controlprograms or logic configurations for pairing the surgical hub 106 withdevices of the surgical system 102 located within the bounds of theoperating room, as described above.

The surgical hub 106 performs a wide range of functions that requiresshort- and long-range communication, such as assisting in a surgicalprocedure, coordinating between devices of the surgical system 102, andgathering and transmitting data to the cloud 104. To properly performits functions, the surgical hub 106 is equipped with a communicationmodule 130 capable of short-range communication with other devices ofthe surgical system 102. The communication module 130 is also capable oflong-range communication with the cloud 104.

The surgical hub 106 is also equipped with an operating-room mappingmodule 133 which is capable of identifying the bounds of an operatingroom, and identifying devices of the surgical system 102 within theoperating room. The surgical hub 106 is configured to identify thebounds of an operating room, and only pair with or connect to potentialdevices of the surgical system 102 that are detected within theoperating room.

In one aspect, the pairing comprises establishing a communication linkor pathway. In another aspect, the pairing comprises establishing acontrol link or pathway.

An initial mapping or evaluation of the bounds of the operating roomtakes place during an initial activation of the surgical hub 106.Furthermore, the surgical hub 106 is configured to maintain spatialawareness during operation by periodically mapping its operating room,which can be helpful in determining if the surgical hub 106 has beenmoved. The reevaluation 3017 can be performed periodically or it can betriggered by an event such as observing a change in the devices of thesurgical system 102 that are deemed within the operating room. In oneaspect, the change is detection 3010 of a new device that was notpreviously deemed as within the bounds of the operating room, asillustrated in FIG. 37. In another aspect, the change is adisappearance, disconnection, or un-pairing of a paired device that waspreviously deemed as residing within the operating room, as illustratedin FIG. 38. The surgical hub 106 may continuously monitor 3035 theconnection with paired devices to detect 3034 the disappearance,disconnection, or un-pairing of a paired device.

In other aspects, reevaluation triggering events can be, for example,changes in surgeons' positions, instrument exchanges, or sensing of anew set of tasks being performed by the surgical hub 106.

In one aspect, the evaluation of the bounds of the room by the surgicalhub 106 is accomplished by activation of a sensor array of theoperating-room mapping module 133 within the surgical hub 106 whichenables it to detect the walls of the operating room.

Other components of the surgical system 102 can be made to be spatiallyaware in the same, or a similar, manner as the surgical hub 106. Forexample, a robotic hub 122 may also be equipped with an operating-roommapping module 133.

The spatial awareness of the surgical hub 106 and its ability to map anoperating room for potential components of the surgical system 102allows the surgical hub 106 to make autonomous decisions about whetherto include or exclude such potential components as part of the surgicalsystem 102, which relieves the surgical staff from dealing with suchtasks. Furthermore, the surgical hub 106 is configured to makeinferences about, for example, the type of surgical procedure to beperformed in the operating room based on information gathered prior to,during, and/or after the performance of the surgical procedure. Examplesof gathered information include the types of devices that are broughtinto the operating room, time of introduction of such devices into theoperating room, and/or the devices sequence of activation.

In one aspect, the surgical hub 106 employs the operating-room mappingmodule 133 to determine the bounds of the surgical theater (e.g., afixed, mobile, or temporary operating room or space) using eitherultrasonic or laser non-contact measurement devices.

Referring to FIG. 34, ultrasound based non-contact sensors 3002 can beemployed to scan the operating theater by transmitting a burst ofultrasound and receiving the echo when it bounces off a perimeter wall3006 of an operating theater to determine the size of the operatingtheater and to adjust Bluetooth pairing distance limits. In one example,the non-contact sensors 3002 can be Ping ultrasonic distance sensors, asillustrated in FIG. 34.

FIG. 34 shows how an ultrasonic sensor 3002 sends a brief chirp with itsultrasonic speaker 3003 and makes it possible for a micro-controller3004 of the operating-room mapping module 133 to measure how long theecho takes to return to the ultrasonic sensor's ultrasonic microphone3005. The micro-controller 3004 has to send the ultrasonic sensor 3002 apulse to begin the measurement. The ultrasonic sensor 3002 then waitslong enough for the micro-controller program to start a pulse inputcommand. Then, at about the same time the ultrasonic sensor 3002 chirpsa 40 kHz tone, it sends a high signal to the micro-controller 3004. Whenthe ultrasonic sensor 3002 detects the echo with its ultrasonicmicrophone 3005, it changes that high signal back to low. Themicro-controller's pulse input command measures the time between thehigh and low changes and stores its measurement in a variable. Thisvalue can be used along with the speed of sound in air to calculate thedistance between the surgical hub 106 and the operating-room wall 3006.

In one example, as illustrated in FIG. 33, a surgical hub 106 can beequipped with four ultrasonic sensors 3002, wherein each of the fourultrasonic sensors is configured to assess the distance between thesurgical hub 106 and a wall of the operating room 3000. A surgical hub106 can be equipped with more or less than four ultrasonic sensors 3002to determine the bounds of an operating room.

Other distance sensors can be employed by the operating-room mappingmodule 133 to determine the bounds of an operating room. In one example,the operating-room mapping module 133 can be equipped with one or morephotoelectric sensors that can be employed to assess the bounds of anoperating room. In one example, suitable laser distance sensors can alsobe employed to assess the bounds of an operating room. Laser-basednon-contact sensors may scan the operating theater by transmitting laserlight pulses, receiving laser light pulses that bounce off the perimeterwalls of the operating theater, and comparing the phase of thetransmitted pulse to the received pulse to determine the size of theoperating theater and to adjust Bluetooth pairing distance limits.

Referring to the top left corner of FIG. 33, a surgical hub 106 isbrought into an operating room 3000. The surgical hub 106 is activatedat the beginning of the set-up that occurs prior to the surgicalprocedure. In the example of FIG. 33, the set-up starts at an actualtime of 11:31:14 (EST) based on a real-time clock. However, at thestated procedure set-up start time, the surgical hub 106 starts 3001 anartificial randomized real-time clock timing scheme at artificial realtime 07:36:00 to protect private patient information.

At artificial real time 07:36:01, the operating-room mapping module 133employs the ultrasonic distance sensors to ultrasonically ping the room(e.g., sends out a burst of ultrasound and listens for the echo when itbounces off the perimeter walls of the operating room as describedabove) to verify the size of the operating room and to adjust pairingdistance limits.

At artificial real time 07:36:03, the data is stripped and time-stamped.At artificial real time 07:36:05, the surgical hub 106 begins pairingdevices located only within the operating room 3000 as verified usingultrasonic distance sensors 3002 of the operating-room mapping module133. The top right corner of FIG. 33 illustrates several example devicesthat are within the bounds of the operating room 3000 and are pairedwith the surgical hub 106, including a secondary display device 3020, asecondary hub 3021, a common interface device 3022, a powered stapler3023, a video tower module 3024, and a powered handheld dissector 3025.On the other hand, secondary hub 3021′, secondary display device 3020′,and powered stapler 3026 are all outside the bounds of the operatingroom 3000 and, accordingly, are not paired with the surgical hub 106.

In addition to establishing a communication link with the devices of thesurgical system 102 that are within the operating room, the surgical hub106 also assigns a unique identification and communication sequence ornumber to each of the devices. The unique sequence may include thedevice's name and a time stamp of when the communication was firstestablished. Other suitable device information may also be incorporatedinto the unique sequence of the device.

As illustrated in the top left corner of FIG. 33, the surgical hub 106has determined that the operating room 3000 bounds are at distances a,−a, b, and −b from the surgical hub 106. Since Device “D” is outside thedetermined bounds of its operating room 3000, the surgical hub 106 willnot pair with the Device “D.” FIG. 35 is an example algorithmillustrating how the surgical hub 106 only pairs with devices within thebounds of its operating room. After activation, the surgical hub 106determines 3007 bounds of the operating room using the operating-roommapping module 133, as described above. After the initial determination,the surgical hub 106 continuously searches for or detects 3008 deviceswithin a pairing range. If a device is detected 3010, the surgical hub106 then determines 3011 whether the detected device is within thebounds of the operating room. The surgical hub 106 pairs 3012 with thedevice if it is determined that the device is within the bounds of theoperating room. In certain instances, the surgical hub 106 will alsoassign 3013 an identifier to the device. If, however, the surgical hub106 determines that the detected device is outside the bounds of theoperating room, the surgical hub 106 will ignore 3014 the device.

Referring to FIG. 36, after an initial determination of the bounds ofthe room, and after an initial pairing of devices located within suchbounds, the surgical hub 106 continues to detect 3015 new devices thatbecome available for pairing. If a new device is detected 3016, thesurgical hub 106 is configured to reevaluate 3017 the bounds of theoperating room prior to pairing with the new device. If the new deviceis determined 3018 to be within the newly determined bounds of theoperating room, then the surgical hub 106 pairs with the device 3019 andassigns 3030 a unique identifier to the new device. If, however, thesurgical hub 106 determines that the new device is outside the newlydetermined bounds of the operating room, the surgical hub 106 willignore 3031 the device.

For pairing, the operating-room mapping module 133 contains a compassand integrated Bluetooth transceiver. Other communication mechanisms,which are not significantly affected by the hospital environment orgeographical location, can be employed. Bluetooth Low Energy (BLE)beacon technology can currently achieve indoor distance measurementswith accuracy of about 1-2 meters, with improved accuracy in closerproximities (within 0-6 meters). To improve the accuracy of the distancemeasurements, a compass is used with the BLE. The operating-room mappingmodule 133 utilizes the BLE and the compass to determine where modulesare located in relation to the patient. For example, two modules facingeach other (detected by compass) with greater than one meter distancebetween them may clearly indicate that the modules are on opposite sidesof the patient. The more “Hub”-enabled modules that reside in theoperating room, the greater the achievable accuracy becomes due totriangulation techniques.

In the situations where multiple surgical hubs 106, modules, and/orother peripherals are present in the same operating room, as illustratedin the top right corner of FIG. 33, the operating-room mapping module133 is configured to map the physical location of each module thatresides within the operating room. This information could be used by theuser interface to display a virtual map of the room, enabling the userto more easily identify which modules are present and enabled, as wellas their current status. In one aspect, the mapping data collected bysurgical hubs 106 are uploaded to the cloud 104, where the data areanalyzed for identifying how an operating room is physically setup, forexample.

The surgical hub 106 is configured to determine a device's location byassessing transmission radio signal strength and direction. ForBluetooth protocols, the Received Signal Strength Indication (RSSI) is ameasurement of the received radio signal strength. In one aspect, thedevices of the surgical system 102 can be equipped with USB Bluetoothdongles. The surgical hub 106 may scan the USB Bluetooth beacons to getdistance information. In another aspect, multiple high-gain antennas ona Bluetooth access point with variable attenuators can produce moreaccurate results than RSSI measurements. In one aspect, the hub isconfigured to determine the location of a device by measuring the signalstrength from multiple antennas. Alternatively, in some examples, thesurgical hub 106 can be equipped with one or more motion sensor devicesconfigured to detect a change in the position of the surgical hub 106.

Referring to the bottom left corner of FIG. 33, the surgical hub 106 hasbeen moved from its original position, which is depicted in dashedlines, to a new position closer to the device “D,” which is stilloutside the bounds of the operating room 3000. The surgical hub 106 inits new position, and based on the previously determined bounds of theoperating room, would naturally conclude that the device “D” is apotential component of the surgical system 102. However, theintroduction of a new device is a triggering event for reevaluation 3017of the bounds of the operating room, as illustrated in the examplealgorithm of FIGS. 35, 37. After performing the reevaluation, thesurgical hub 106 determines that the operating room bounds have changed.Based on the new bounds, at distances a_(new), −a_(new), b_(new), and−b_(new), the surgical hub 106 concludes that it has been moved and thatthe Device “D” is outside the newly determined bounds of its operatingroom. Accordingly, the surgical hub 106 will still not pair with theDevice “D.”

In one aspect, one or more of the processes depicted in FIGS. 35-39 canbe executed by a control circuit of a surgical hub 106, as depicted inFIG. 10 (processor 244). In another aspect, one or more of the processesdepicted in FIGS. 35-39 can be executed by a cloud computing system 104,as depicted in FIG. 1. In yet another aspect, one or more of theprocesses depicted in FIGS. 35-39 can be executed by at least one of theaforementioned cloud computing systems 104 and/or a control circuit of asurgical hub 106 in combination with a control circuit of a modulardevice, such as the microcontroller 461 of the surgical instrumentdepicted in FIG. 12, the microcontroller 620 of the surgical instrumentdepicted in FIG. 16, the control circuit 710 of the robotic surgicalinstrument 700 depicted in FIG. 17, the control circuit 760 of thesurgical instruments 750, 790 depicted in FIGS. 18-19, or the controller838 of the generator 800 depicted in FIG. 20.

Spatial Awareness of Surgical Hubs in Operating Rooms

During a surgical procedure, a surgical instrument such as an ultrasonicor an RF surgical instrument can be coupled to a generator module 140 ofthe surgical hub 106. In addition, a separate surgical instrumentcontroller such as a foot, or hand, switch or activation device can beused by an operator of the surgical instrument to activate the energyflow from the generator to the surgical instrument. Multiple surgicalinstrument controllers and multiple surgical instruments can be usedconcurrently in an operating room. Pressing or activating the wrongsurgical instrument controller can lead to undesirable consequences.Aspects of the present disclosure present a solution in which thesurgical hub 106 coordinates the pairing of surgical instrumentcontrollers and surgical instruments to ensure patient and operatorsafety.

Aspects of the present disclosure are presented for a surgical hub 106configured to establish and sever pairings between components of thesurgical system 102 within the bounds of the operating room tocoordinate flow of information and control actions between suchcomponents. The surgical hub 106 can be configured to establish apairing between a surgical instrument controller and a surgicalinstrument that reside within the bounds of an operating room ofsurgical hub 106.

In various aspects, the surgical hub 106 can be configured to establishand sever pairings between components of the surgical system 102 basedon operator request or situational and/or spatial awareness. The hubsituational awareness is described in greater detail below in connectionwith FIG. 86.

Aspects of the present disclosure are presented for a surgical hub foruse with a surgical system in a surgical procedure performed in anoperating room. The surgical hub includes a control circuit thatselectively forms and severs pairings between devices of the surgicalsystem. In one aspect, the hub includes a control circuit is configuredto pair the hub with a first device of the surgical system, assign afirst identifier to the first device, pair the hub with a second deviceof the surgical system, assign a second identifier to the second device,and selectively pair the first device with the second device. In oneaspect, the surgical hub includes a storage medium, wherein the controlcircuit is configured to store a record indicative of the pairingbetween the first device and the second device in the storage medium. Inone aspect, the pairing between the first device and the second devicedefines a communication pathway therebetween. In one aspect, the pairingbetween the first device and the second device defines a control pathwayfor transmitting control actions from the second device to the firstdevice.

Further to the above, in one aspect, the control circuit is furtherconfigured to pair the hub with a third device of the surgical system,assign a third identifier to the third device, sever the pairing betweenthe first device and the second device, and selectively pair the firstdevice with the third device. In one aspect, the control circuit isfurther configured to store a record indicative of the pairing betweenthe first device and the third device in the storage medium. In oneaspect, the pairing between the first device and the third devicedefines a communication pathway therebetween. In one aspect, the pairingbetween the first device and the third device defines a control pathwayfor transmitting control actions from the third device to the firstdevice.

In various aspects, the surgical hub includes a processor and a memorycoupled to the processor. The memory stores instructions executable bythe processor to selectively form and sever pairings between the devicesof the surgical system, as described above. In various aspects, thepresent disclosure provides a non-transitory computer-readable mediumstoring computer-readable instructions which, when executed, cause amachine to selectively form and sever pairings between the devices ofthe surgical system, as described above. FIGS. 40 and 41 are logic flowdiagrams of processes depicting control programs or logic configurationsfor selectively forming and severing pairings between the devices of thesurgical system, as described above.

In one aspect, the surgical hub 106 establishes a first pairing with asurgical instrument and a second pairing with the surgical instrumentcontroller. The surgical hub 106 then links the pairings togetherallowing the surgical instrument and the surgical instrument controllerto operate with one another. In another aspect, the surgical hub 106 maysever an existing communication link between a surgical instrument and asurgical instrument controller, then link the surgical instrument toanother surgical instrument controller that is linked to the surgicalhub 106.

In one aspect, the surgical instrument controller is paired to twosources. First, the surgical instrument controller is paired to thesurgical hub 106, which includes the generator module 140, for controlof its activation. Second, the surgical instrument controller is alsopaired to a specific surgical instrument to prevent inadvertentactivation of the wrong surgical instrument.

Referring to FIGS. 40 and 42, the surgical hub 106 may cause thecommunication module 130 to pair 3100 or establish a first communicationlink 3101 with a first device 3102 of the surgical system 102, which canbe a first surgical instrument. Then, the hub may assign 3104 a firstidentification number to the first device 3102. This is a uniqueidentification and communication sequence or number that may include thedevice's name and a time stamp of when the communication was firstestablished.

In addition, the surgical hub 106 may then cause the communicationmodule 130 to pair 3106 or establish a second communication link 3107with a second device 3108 of the surgical system 102, which can be asurgical instrument controller. The surgical hub 106 then assigns 3110 asecond identification number to the second device 3108.

In various aspects, the steps of pairing a surgical hub 106 with adevice may include detecting the presence of a new device, determiningthat the new device is within bounds of the operating room, as describedabove in greater detail, and only pairing with the new device if the newdevice is located within the bounds of the operating room.

The surgical hub 106 may then pair 3112 or authorize a communicationlink 3114 to be established between the first device 3102 and the seconddevice 3108, as illustrated in FIG. 42. A record indicative of thecommunication link 3114 is stored by the surgical hub 106 in the storagearray 134. In one aspect, the communication link 3114 is establishedthrough the surgical hub 106. In another aspect, as illustrated in FIG.42, the communication link 3114 is a direct link between the firstdevice 3102 and the second device 3108.

Referring to FIGS. 41 and 43, the surgical hub 106 may then detect andpair 3120 or establish a third communication link 3124 with a thirddevice 3116 of the surgical system 102, which can be another surgicalinstrument controller, for example. The surgical hub 106 may then assign3126 a third identification number to the third device 3116.

In certain aspects, as illustrated in FIG. 43, the surgical hub 106 maythen pair 3130 or authorize a communication link 3118 to be establishedbetween the first device 3102 and the third device 3116, while causingthe communication link 3114 to be severed 3128, as illustrated in FIG.43. A record indicative of the formation of the communication link 3118and severing of the communication link 3114 is stored by the surgicalhub 106 in the storage array 134. In one aspect, the communication link3118 is established through the surgical hub 106. In another aspect, asillustrated in FIG. 43, the communication link 3118 is a direct linkbetween the first device 3102 and the third device 3116.

As described above, the surgical hub 106 can manage an indirectcommunication between devices of the surgical system 102. For example,in situations where the first device 3102 is a surgical instrument andthe second device 3108 is a surgical instrument controller, an output ofthe surgical instrument controller can be transmitted through thecommunication link 3107 to the surgical hub 106, which may then transmitthe output to the surgical instrument through the communication link3101.

In making a decision to connect or sever a connection between devices ofthe surgical system 102, the surgical hub 106 may rely on perioperativedata received or generated by the surgical hub 106. Perioperative dataincludes operator input, hub-situational awareness, hub-spatialawareness, and/or cloud data. For example, a request can be transmittedto the surgical hub 106 from an operator user-interface to assign asurgical instrument controller to a surgical instrument. If the surgicalhub 106 determines that the surgical instrument controller is alreadyconnected to another surgical instrument, the surgical hub 106 may severthe connection and establish a new connection per the operator'srequest.

In certain examples, the surgical hub 106 may establish a firstcommunication link between the visualization system 108 and the primarydisplay 119 to transmit an image, or other information, from thevisualization system 108, which resides outside the sterile field, tothe primary display 119, which is located within the sterile field. Thesurgical hub 106 may then sever the first communication link andestablish a second communication link between a robotic hub 122 and theprimary display 119 to transmit another image, or other information,from the robotic hub 122 to the primary display 119, for example. Theability of the surgical hub 106 to assign and reassign the primarydisplay 119 to different components of the surgical system 102 allowsthe surgical hub 106 to manage the information flow within the operatingroom, particularly between components inside the sterile field andoutside the sterile field, without physically moving these components.

In another example that involves the hub-situational awareness, thesurgical hub 106 may selectively connect or disconnect devices of thesurgical system 102 within an operating room based on the type ofsurgical procedure being performed or based on a determination of anupcoming step of the surgical procedure that requires the devices to beconnected or disconnected. The hub situational awareness is described ingreater detail below in connection with FIG. 86.

Referring to FIG. 44, the surgical hub 106 may track 3140 theprogression of surgical steps in a surgical procedure and may coordinatepairing and unpairing of the devices of the surgical system 102 basedupon such progression. For example, the surgical hub 106 may determinethat a first surgical step requires use of a first surgical instrument,while a second surgical step, occurring after completion of the firstsurgical step, requires use of a second surgical instrument.Accordingly, the surgical hub 106 may assign a surgical instrumentcontroller to the first surgical instrument for the duration of thefirst surgical step. After detecting completion 3142 of the firstsurgical step, the surgical hub 106 may cause the communication linkbetween the first surgical instrument and the surgical instrumentcontroller to be severed 3144. The surgical hub 106 may then assign thesurgical instrument controller to the second surgical instrument bypairing 3146 or authorizing the establishment of a communication linkbetween the surgical instrument controller and the second surgicalinstrument.

Various other examples of the hub-situational awareness, which caninfluence the decision to connect or disconnect devices of the surgicalsystem 102, are described in greater detail below in connection withFIG. 86.

In certain aspects, the surgical hub 106 may utilize its spatialawareness capabilities, as described in greater detail elsewhere herein,to track progression of the surgical steps of a surgical procedure andautonomously reassign a surgical instrument controller from one surgicalinstrument to another surgical instrument within the operating room ofthe surgical hub 106. In one aspect, the surgical hub 106 uses Bluetoothpairing and compass information to determine the physical position ofthe components of the surgical system 102.

In the example illustrated in FIG. 2, the surgical hub 106 is pairedwith a first surgical instrument held by a surgical operator at theoperating table and a second surgical instrument positioned on a sidetray. A surgical instrument controller can be selectively paired witheither the first surgical instrument or the second surgical instrument.Utilizing the Bluetooth pairing and compass information, the surgicalhub 106 autonomously assigns the surgical instrument controller to thefirst surgical instrument because of its proximity to the patient.

After completion of the surgical step that involved using the firstsurgical instrument, the first surgical instrument may be returned tothe side tray or otherwise moved away from the patient. Detecting achange in the position of the first surgical instrument, the surgicalhub 106 may sever the communication link between the first surgicalinstrument and the surgical instrument controller to protect againstunintended activation of the first surgical instrument by the surgicalinstrument controller. The surgical hub 106 may also reassign thesurgical instrument controller to another surgical instrument if thesurgical hub 106 detects that it has been moved to a new position at theoperating table.

In various aspects, devices of the surgical system 102 are equipped withan easy hand-off operation mode that would allow one user to giveactivation control of a device they currently control to anothersurgical instrument controller within reach of another operator. In oneaspect, the devices are equipped to accomplish the hand-off through apredetermined activation sequence of the devices that causes the devicesthat are activated in the predetermined activation sequence to pair withone another.

In one aspect, the activation sequence is accomplished by powering onthe devices to be paired with one another in a particular order. Inanother aspect, the activation sequence is accomplished by powering onthe devices to be paired with one another within a predetermined timeperiod. In one aspect, the activation sequence is accomplished byactivating communication components, such as Bluetooth, of the devicesto be paired with one another in a particular order. In another aspect,the activation sequence is accomplished by activating communicationcomponents, such as Bluetooth, of the devices to be paired within oneanother within a predetermined time period.

Alternatively, the hand-off can also be accomplished by a selection of adevice through one of the surgical-operator input devices. After theselection is completed, the next activation by another controller wouldallow the new controller to take control.

In various aspects, the surgical hub 106 can be configured to directlyidentify components of the surgical system 102 as they are brought intoan operating room. In one aspect, the devices of the surgical system 102can be equipped with an identifier recognizable by the surgical hub 106,such as, for example, a bar code or an RFID tag. NFC can also beemployed. The surgical hub 106 can be equipped with a suitable reader orscanner for detecting the devices brought into the operating room.

The surgical hub 106 can also be configured to check and/or updatevarious control programs of the devices of the surgical system 102. Upondetecting and establishing a communication link of a device of thesurgical system 102, the surgical hub 106 may check if its controlprogram is up to date. If the surgical hub 106 determines that a laterversion of the control program is available, the surgical hub 106 maydownload the latest version from the cloud 104 and may update the deviceto the latest version. The surgical hub 106 may issue a sequentialidentification and communication number to each paired or connecteddevice.

Cooperative Utilization of Data Derived from Secondary Sources byIntelligent Surgical Hubs

In a surgical procedure, the attention of a surgical operator must befocused on the tasks at hand. Receiving information from multiplesources, such as, for example, multiple displays, although helpful, canalso be distracting. The imaging module 138 of the surgical hub 106 isconfigured to intelligently gather, analyze, organize/package, anddisseminate relevant information to the surgical operator in a mannerthat minimizes distractions.

Aspects of the present disclosure are presented for cooperativeutilization of data derived from multiple sources, such as, for example,an imaging module 138 of the surgical hub 106. In one aspect, theimaging module 138 is configured to overlay data derived from one ormore sources onto a livestream destined for the primary display 119, forexample. In one aspect, the overlaid data can be derived from one ormore frames acquired by the imaging module 138. The imaging module 138may commandeer image frames on their way for display on a local displaysuch as, for example, the primary display 119. The imaging module 138also comprises an image processor that may preform an array of localimage processing on the commandeered images.

Furthermore, a surgical procedure generally includes a number ofsurgical tasks which can be performed by one or more surgicalinstruments guided by a surgical operator or a surgical robot, forexample. Success or failure of a surgical procedure depends on thesuccess or failure of each of the surgical tasks. Without relevant dataon the individual surgical tasks, determining the reason for a failedsurgical procedure is a question of probability.

Aspects of the present disclosure are presented for capturing one ormore frames of a livestream of a surgical procedure for furtherprocessing and/or pairing with other data. The frames may be captured atthe completion of a surgical task (also referred to elsewhere herein as“surgical step”) to assess whether the surgical task was completedsuccessfully. Furthermore, the frames, and the paired data, can beuploaded to the cloud for further analysis.

In one aspect, one or more captured images are used to identify at leastone previously completed surgical task to evaluate the outcome of thesurgical task. In one aspect, the surgical task is a tissue-staplingtask. In another aspect, the surgical task is an advanced energytransection.

FIG. 45 is a logic flow diagram of a process 3210 depicting a controlprogram or a logic configuration for overlaying information derived fromone or more still frames of a livestream of a remote surgical site ontothe livestream. The process 3210 includes receiving 3212 a livestream ofa remote surgical site from a medical imaging device 124, for example,capturing 3214 at least one image frame of a surgical step of thesurgical procedure from the livestream, deriving 3216 informationrelevant to the surgical step from data extracted from the at least oneimage frame, and overlaying 3218 the information onto the livestream.

In one aspect, the still frames can be of a surgical step performed atthe remote surgical site. The still frames can be analyzed forinformation regarding completion of the surgical step. In one aspect,the surgical step comprises stapling tissue at the surgical site. Inanother aspect, the surgical task comprises applying energy to tissue atthe surgical site.

FIG. 46 is a logic flow diagram of a process 3220 depicting a controlprogram or a logic configuration for differentiating among surgicalsteps of a surgical procedure. The process 3220 includes receiving 3222a livestream of a surgical site from a medical imaging device 124, forexample, capturing 3224 at least one first image frame of a firstsurgical step of the surgical procedure from the livestream, deriving3226 information relevant to the first surgical step from data extractedfrom the at least one image frame, capturing 3228 at least one secondimage frame of a second surgical step of the surgical procedure from thelivestream, and differentiating 3229 among the first surgical step andthe second surgical step based on the at least one first image frame andthe at least one second image frame.

FIG. 47 is a logic flow diagram of a process 3230 depicting a controlprogram or a logic configuration for differentiating among surgicalsteps of a surgical procedure. The process 3232 includes receiving 3232a livestream of the surgical site from a medical imaging device 124, forexample, capturing 3234 image frames of the surgical steps of thesurgical procedure from the livestream and differentiating 3236 amongthe surgical steps based on data extracted from the image frames.

FIG. 48 is a logic flow diagram of a process 3240 depicting a controlprogram or a logic configuration for identifying a staple cartridge frominformation derived from one or more still frames of staples deployedfrom the staple cartridge into tissue. The process 3240 includesreceiving 3242 a livestream of the surgical site from medical imagingdevice 124, for example, capturing 3244 an image frame from thelivestream, detecting 3246 a staple pattern in the image frame, whereinthe staple pattern is defined by staples deployed from a staplecartridge into tissue at the surgical site. The process 3240 furtherincludes identifying 3248 the staple cartridge based on the staplepattern.

In various aspects, one or more of the steps of the processes 3210,3220, 3230, 3240 can be executed by a control circuit of an imagingmodule of a surgical hub, as depicted in FIGS. 3, 9, 10. In certainexamples, the control circuit may include a processor and a memorycoupled to the processor, wherein the memory stores instructionsexecutable by the processor to perform one or more of the steps of theprocesses 3210, 3220, 3230, 3240. In certain examples, a non-transitorycomputer-readable medium stores computer-readable instructions which,when executed, cause a machine to perform one or more of the steps ofthe processes 3210, 3220, 3230, 3240. For economy, the followingdescription of the processes 3210, 3220, 3230, 3240 will be described asbeing executed by the control circuit of an imaging module of a surgicalhub; however, it should be understood that the execution of theprocesses 3210, 3220, 3230, 3240 can be accomplished by any of theaforementioned examples.

Referring to FIGS. 34 and 49, a surgical hub 106 is in communicationwith a medical imaging device 124 located at a remote surgical siteduring a surgical procedure. The imaging module 138 receives alivestream of the remote surgical site transmitted by the imaging device124 to a primary display 119, for example, in accordance with steps3212, 3222, 3232, 3242.

Further to the above, the imaging module 138 of the surgical hub 106includes a frame grabber 3200. The frame grabber 3200 is configured tocapture (i.e., “grabs”) individual, digital still frames from thelivestream transmitted by the imaging device 124, for example, to aprimary display 119, for example, during a surgical procedure, inaccordance with steps 3214, 3224, 3234, 3244. The captured still framesare stored and processed by a computer platform 3203 (FIG. 49) of theimaging module 138 to derive information about the surgical procedure.Processing of the captured frames may include performance of simpleoperations, such as histogram calculations, 2D filtering, and arithmeticoperations on arrays of pixels to the performance of more complex tasks,such as object detection, 3D filtering, and the like.

In one aspect, the derived information can be overlaid onto thelivestream. In one aspect, the still frames and/or the informationresulting from processing the still frames can be communicated to acloud 104 for data aggregation and further analysis.

In various aspects, the frame grabber 3200 may include a digital videodecoder and a memory for storing the acquired still frames, such as, forexample, a frame buffer. The frame grabber 3200 may also include a businterface through which a processor can control the acquisition andaccess the data and a general purpose I/O for triggering imageacquisition or controlling external equipment.

As described above, the imaging device 124 can be in the form of anendoscope, including a camera and a light source positioned at a remotesurgical site, and configured to provide a livestream of the remotesurgical site at the primary display 119, for example.

In various aspects, image recognition algorithms can be implemented toidentify features or objects in still frames of a surgical site that arecaptured by the frame grabber 3200. Useful information pertaining to thesurgical steps associated with the captured frames can be derived fromthe identified features. For example, identification of staples in thecaptured frames indicates that a tissue-stapling surgical step has beenperformed at the surgical site. The type, color, arrangement, and sizeof the identified staples can also be used to derive useful informationregarding the staple cartridge and the surgical instrument employed todeploy the staples. As described above, such information can be overlaidon a livestream directed to a primary display 119 in the operating room.

The image recognition algorithms can be performed at least in partlocally by the computer platform 3203 (FIG. 49) of the imaging module138. In certain instances, the image recognition algorithms can beperformed at least in part by the processor module 132 of the surgicalhub 106. An image database can be utilized in performance of the imagerecognition algorithms and can be stored in a memory 3202 of thecomputer platform 3203. Alternatively, the imaging database can bestored in the storage array 134 (FIG. 3) of the surgical hub 106. Theimage database can be updated from the cloud 104.

An example image recognition algorithm that can be executed by thecomputer platform 3203 may include a key points-based comparison and aregion-based color comparison. The algorithm includes: receiving aninput at a processing device, such as, for example, the computerplatform 3203; the input, including data related to a still frame of aremote surgical site; performing a retrieving step, including retrievingan image from an image database and, until the image is either acceptedor rejected, designating the image as a candidate image; performing animage recognition step, including using the processing device to performan image recognition algorithm on the still frame and candidate imagesin order to obtain an image recognition algorithm output; and performinga comparison step, including: if the image recognition algorithm outputis within a pre-selected range, accepting the candidate image as thestill frame and if the image recognition algorithm output is not withinthe pre-selected range, rejecting the candidate image and repeating theretrieving, image recognition, and comparison steps.

Referring to FIGS. 50-52, in one example, a surgical step involvesstapling and cutting tissue. FIG. 50 depicts a still frame 3250 of astapled and cut tissue T. A staple deployment 3252 includes staples3252′, 3252″ from a first staple cartridge. A second staple deployment3254 includes staples 3254′, 3254″ from a second staple cartridge. Aproximal portion 3253 of the staple deployment 3252 overlaps with adistal portion 3255 of the staple deployment 3254. Six rows of stapleswere deployed in each deployment. Tissue T was cut between the third andfourth rows of each deployment, but only one side of the stapled tissueT is fully shown.

In various aspects, the imaging module 138 identifies one or more of thestaples 3252′, 3252″, 3254′, 3254″ in the still frame 3250, which wereabsent in a previous still frame captured by the frame grabber 3200. Theimaging module 138 then concludes that a surgical stapling and cuttinginstrument has been used at the surgical site.

In the example of FIG. 50, the staple deployment 3252 includes twodifferent staples 3252′, 3252″. Likewise, the staple deployment 3254includes two different staples 3254′, 3254″. For brevity, the followingdescription focuses on the staples 3252′, 3252″, but is equallyapplicable to the staples 3254′, 3254″. The staples 3252′, 3252″ arearranged in a predetermined pattern or sequence that forms a uniqueidentifier corresponding to the staple cartridge that housed the staples3252′, 3252″. The unique pattern can be in a single row or multiple rowsof the staples 3250. In one example, the unique pattern can be achievedby alternating the staples 3252′, 3252″ at a predetermined arrangement.

In one aspect, multiple patterns can be detected in a firing of staples.Each pattern can be associated with a unique characteristic of thestaples, the staple cartridge that housed the staples, and/or thesurgical instrument that was employed to fire the staple. For example, afiring of staples may include patterns that represent staple form,staple size, and/or location of the firing.

In the example, of FIG. 50, the imaging module 138 may identify a uniquepattern of the staples 3252 from the still frame 3250. A databasestoring staple patterns and corresponding identification numbers ofstaple cartridges can then be explored to determine an identificationnumber of a staple cartridge that housed the staples 3252.

The patterns of the example of FIG. 50 are based on only two differentstaples; however, other aspects may include three or more differentstaples. The different staples can be coated with different coatings,which can be applied to the staples by one or more of the followingmethods: anodizing, dying, electro-coating, photoluminescent coating,application of nitrides, methyl methacylate, painting, powder coating,coating with paraffins, oil stains or phosphor coatings, the use ofhydroxyapatite, polymers, titanium oxinitrides, zinc sulfides, carbides,etc. It should be noted that, while the listed coatings are fairlyspecific as disclosed herein, other coatings known in the art todistinguish the staple are within the contemplated scope of the presentdisclosure.

In the example of FIGS. 50-52, the staples 3252′ are anodized staples,while the staples 3252″ are non-anodized staples. In one aspect, thedifferent staples may comprise two or more different colors. Differentmetal staples may comprise magnetic or radioactive staple markers thatdifferentiate them from unmarked staples.

FIG. 51 illustrates a staple deployment 3272 deployed into tissue from astaple cartridge via a surgical instrument. Only three staple rows 3272a, 3272 b, 3272 c are depicted in FIG. 51. The rows 3272 a, 3272 b, 3272c are arranged between a medial line, where the tissue was cut, and alateral line at the tissue edge. For clarity, the inner row 3272 a ofstaples is redrawn separately to the left and the outer two rows 3272 b,3272 c are redrawn separately to the right. A proximal end 3273 and adistal end portion of the staple deployment 3272 are also redrawn inFIG. 51 for clarity.

The staple deployment 3272 includes two different staples 3272′, 3272″that are arranged in predetermined patterns that serve variousfunctions. For example, the inner row 3272 a comprises a pattern ofalternating staples 3272′, 3272″, which defines a metric for distancemeasurements in the surgical field. In other words, the pattern of theinner row 3272 a acts as a ruler for measuring distances, which can behelpful in accurately determining the position of a leak, for example.The outer rows 3272 b, 3272 c define a pattern that represents anidentification number of the staple cartridge that housed the staples3272′, 3272″.

Furthermore, unique patterns at the ends of the staple deployment 3272identify the proximal end portion 3273 and distal end portion 3275. Inthe example of FIG. 51, a unique arrangement of three staples 3272″identifies the distal end 3275, while a unique arrangement of fourstaples 3272″ identifies the proximal end 3273. Identification of theproximal and distal ends of a staple deployment allows the imagingmodule 128 to distinguish between different staple deployments within acaptured frame, which can be useful in pointing the source of a leak,for example.

In various aspects, the imaging module 138 may detect a sealed tissue ina still frame of a remote surgical site captured by the frame grabber3200. Detection of the sealed tissue can be indicative of a surgicalstep that involves applying therapeutic energy to tissue.

Sealing tissue can be accomplished by the application of energy, such aselectrical energy, for example, to tissue captured or clamped within anend effector of a surgical instrument in order to cause thermal effectswithin the tissue. Various mono-polar and bi-polar RF surgicalinstruments and harmonic surgical instruments have been developed forsuch purposes. In general, the delivery of energy to captured tissue canelevate the temperature of the tissue and, as a result, the energy canat least partially denature proteins within the tissue. Such proteins,like collagen, for example, can be denatured into a proteinaceousamalgam that intermixes and fuses, or seals, together as the proteinsrenature.

Accordingly, sealed tissue has a distinct color and/or shape that can bedetected by the imaging module 138 using image recognition algorithms,for example. In addition, smoke detection at the surgical site canindicate that therapeutic energy application to the tissue is inprogress.

Further to the above, the imaging module 138 of the surgical hub 106 iscapable of differentiating between surgical steps of a surgicalprocedure based on the captured frames. As described above, a stillframe that comprises fired staples is indicative of a surgical stepinvolving tissue stapling, while a still frame that comprises a sealedtissue is indicative of a surgical step involving energy application totissue.

In one aspect, the surgical hub 106 may selectively overlay informationrelevant to a previously completed surgical task onto the livestream.For example, the overlaid information may comprise image data from astill frame of the surgical site captured during the previouslycompleted surgical task. Furthermore, guided by common landmarklocations at the surgical site, the imaging module 138 can interlace oneimage frame to another to establish and detect surgical locations andrelationship data of a previously completed surgical task.

In one example, the surgical hub 106 is configured to overlayinformation regarding a potential leak in a tissue treated by staplingor application of therapeutic energy in a previously completed surgicaltask. The potential leak can be spotted by the imaging module 138 duringthe processing of a still frame of the tissue. The surgical operator canbe alerted about the leak by overlaying information about the potentialleak onto the livestream.

In various aspects, still frames of an end effector of a surgicalinstrument at a surgical site can be used to identify the surgicalinstrument. For example, the end effector may include an identificationnumber that can be recognized by the imaging module 138 during imageprocessing of the still frame. Accordingly, the still frames captured bythe imaging module 138 may be used to identify a surgical instrumentutilized in a surgical step of a surgical procedure. The still framesmay also include useful information regarding the performance of thesurgical instrument. All such information can be uploaded to the cloud104 for data aggregation and further analysis.

In various examples, the surgical hub 106 may also selectively overlayinformation relevant to a current or upcoming surgical task, such as ananatomical location or a surgical instrument suitable for the surgicaltask.

The imaging module 138 may employ various images and edge detectiontechniques to track a surgical site where a surgical instrument was usedto complete a surgical task. Success or failure of the surgical task canthen be assessed. For example, a surgical instrument can be employed toseal and/or cut tissue at the surgical site. A still frame of thesurgical site can be stored in the memory 3202 or the storage array 134of the surgical hub 106, for example, upon completion of the surgicaltask.

In the following surgical step, the quality of the seal can be testedvia different mechanisms. To ensure that the testing is accuratelyapplied to the treated tissue, the stored still frame of the surgicalsite is overlaid onto the livestream in search of a match. Once a matchis found, the testing can take place. One or more additional stillframes can be taken during the testing, which can be later analyzed bythe imaging module 138 of the surgical hub 106. The testing mechanismsinclude bubble detection, bleeding detection, dye detection (where a dyeis employed at the surgical site), and/or burst stretch detection (wherea localized strain is applied adjacent to an anastomosis site), forexample.

The imaging module 138 may capture still frames of the response of thetreated tissue to these tests, which can be stored in the memory 3202 orthe storage array 134 of the surgical hub 106, for example. The stillframes can be stored alone or in combination with other data, such as,for example, data from the surgical instrument that performed the tissuetreatment. The paired data can also be uploaded to the cloud 104 foradditional analysis and/or pairing.

In various aspects, the still frames captured by the frame grabber 3200can be processed locally, paired with other data, and can also betransmitted to the cloud 104. The size of the processed and/ortransmitted data will depend on the number of captured frames. Invarious aspects, the rate at which the frame grabber 3200 captures thestill frames from the livestream can be varied in an effort to reducethe size of the data without sacrificing quality.

In one aspect, the frame-capturing rate may depend on the type ofsurgical task being performed. Certain surgical tasks may need a highernumber of still frames than others for an evaluation of success orfailure. The frame-capturing rate can be scalded to accommodate suchneeds.

In one aspect, the frame-capturing rate is dependent upon the detectedmotion of the imaging device 124. In use, an imaging device 124 maytarget one surgical site for a period of time. Observing no or minorchanges in the still frames captured while the imaging device 124 is notbeing moved, the imaging module 138 may reduce the frame-capturing rateof the frame grabber 3200. If the situation changes, however, wherefrequent motion is detected, the imaging module 138 may respond byincreasing the frame-capturing rate of the frame grabber 3200. In otherwords, the imaging module 138 may be configured to correlate theframe-capturing rate of the frame grabber 3200 with the detected degreeof motion of the imaging device 124.

For additional efficiency, only portions of the still frames, wheremotion is detected, need to be stored, processed, and/or transmitted tothe cloud 104. The imaging module 138 can be configured to select theportions of the still frames where motion is detected. In one example,motion detection can be achieved by comparing a still frame to apreviously captured still frame. If movement is detected, the imagingmodule 138 may cause the frame grabber 3200 to increase theframe-capturing rate, but only the portions where motion is detected arestored, processed, and/or transmitted to the cloud 104.

In another aspect, the data size can be managed by scaling theresolution of the captured information based on the area of the screenwhere the focal point is or where end effectors are located, forexample. The remainder of the screen could be captured at a lowerresolution.

In one aspect, the corners of the screen and the edges could generallybe captured at a lower resolution. The resolution, however, can bescalded up if an event of significance is observed.

During a surgical procedure, the surgical hub 106 can be connected tovarious operating-room monitoring devices, such as, for example, heartrate monitors and insufflation pumps. Data collected from these devicescan improve the situational awareness of the surgical hub 106. The hubsituational awareness is described in greater detail below in connectionwith FIG. 86.

In one example, the surgical hub 106 can be configured to utilizepatient data received from a heart rate monitor connected along withdata regarding the location of the surgical site to assess proximity ofthe surgical site to sensory nerves. An increase in the patient's heartrate, when combined with anatomical data indicating that the surgicalsite is in a region high in sensory nerves, can be construed as anindication of sensory nerve proximity. Anatomical data can be availableto the surgical hub 106 through accessing patient records (e.g., an EMRdatabase containing patient records).

The surgical hub 106 may be configured to determine the type of surgicalprocedure being performed on a patient from data received from one ormore of the operating-room monitoring devices, such as, for example,heart rate monitors and insufflation pumps. Abdominal surgicalprocedures generally require insufflation of the abdomen, whileinsufflation is not required in theoretic surgery. The surgical hub 106can be configured to determine whether a surgical procedure is anabdominal or a thoracic surgical procedure by detecting whether theinsufflation pump is active. In one aspect, the surgical hub 106 may beconfigured to monitor insufflation pressure on the output side of theinsufflation pump in order to determine whether the surgical procedurebeing performed is one that requires insufflation.

The surgical hub 106 may also gather information from other secondarydevices in the operating room to assess, for example, whether thesurgical procedure is a vascular or avascular procedure.

The surgical hub 106 may also monitor AC current supply to one or moreof its components to assess whether a component is active. In oneexample, the surgical hub 106 is configured to monitor AC current supplyto the generator module to assess whether the generator is active, whichcan be an indication that the surgical procedure being performed is onethat requires application of energy to seal tissue.

In various aspects, secondary devices in the operating room that areincapable of communication with the surgical hub 106 can be equippedwith communication interface devices (communication modules) that canfacilitate pairing of these devices with the surgical hub 106. In oneaspect, the communication interface devices may be configured to bebridging elements, which would allow them two-way communication betweenthe surgical hub 106 and such devices.

In one aspect, the surgical hub 106 can be configured to control one ormore operational parameters of a secondary device through acommunication interface device. For example, the surgical hub 106 can beconfigured to increase or decrease the insufflation pressure through acommunication interface device coupled to an insufflation device.

In one aspect, the communication interface device can be configured toengage with an interface port of the device. In another aspect, thecommunication interface device may comprise an overlay or otherinterface that directly interacts with a control panel of the secondarydevice. In other aspects, the secondary devices, such as, for example,the heart rate monitor and/or the insufflation devices, can be equippedwith integrated communication modules that allow them to pair with thehub for two-way communication therewith.

In one aspect, the surgical hub 106 can also be connected through acommunication interface device, for example, to muscle pads that areconnected to the neuro-stim detection devices to improve resolution of anerve-sensing device.

Furthermore, the surgical hub 106 can also be configured to manageoperating room supplies. Different surgical procedures require differentsupplies. For example, two different surgical procedures may requiredifferent sets of surgical instruments. Certain surgical procedures mayinvolve using a robotic system, while others may not. Furthermore, twodifferent surgical procedures may require staple cartridges that aredifferent in number, type, and/or size. Accordingly, the suppliesbrought into the operating room can provide clues as to the nature ofthe surgical procedure that will be performed.

In various aspects, the surgical hub 106 can be integrated with anoperating room supplies scanner to identify items pulled into theoperating room and introduced into the sterile field. The surgical hub106 may utilize data from the operating room supplies scanner, alongwith data from the devices of the surgical system 102 that are pairedwith the surgical hub 106, to autonomously determine the type ofsurgical procedure that will be performed. In one example, the surgicalhub 106 may record a list of serial numbers of the smart cartridge thatare going to be used in the surgical procedure. During the surgicalprocedure, the surgical hub 106 may gradually remove the staples thathave been fired, based on information collected from the staplecartridge chips. In one aspect, the surgical hub 106 is configured tomake sure that all the items are accounted for at the end of theprocedure.

Surgical Hub Control Arrangements

In a surgical procedure, a second surgical hub may be brought into anoperating room already under the control of a first surgical hub. Thesecond surgical hub can be, for example, a surgical robotic hub broughtinto the operating room as a part of a robotic system. Withoutcoordination between the first and second surgical hubs, the roboticsurgical hub will attempt to pair with all the other components of thesurgical system 102 that are within the operating room. The confusionarising from the competition between two hubs in a single operating roomcan lead to undesirable consequences. Also, sorting out the instrumentdistribution between the hubs during the surgical procedure can be timeconsuming.

Aspects of the present disclosure are presented for a surgical hub foruse with a surgical system in a surgical procedure performed in anoperating room. A control circuit of the surgical hub is configured todetermine the bounds of the operating room and establish a controlarrangement with a detected surgical hub located within the bounds ofthe operating room.

In one aspect, the control arrangement is a peer-to-peer arrangement. Inanother aspect, the control arrangement is a master-slave arrangement.In one aspect, the control circuit is configured to select one of amaster mode of operation or a slave mode of operation in themaster-slave arrangement. In one aspect, the control circuit isconfigured to surrender control of at least one surgical instrument tothe detected surgical hub in the slave mode of operation.

In one aspect, the surgical hub includes an operating room mappingcircuit that includes a plurality of non-contact sensors configured tomeasure the bounds of the operating room.

In various aspects, the surgical hub includes a processor and a memorycoupled to the processor. The memory stores instructions executable bythe processor to coordinate a control arrangement between surgical hubs,as described above. In various aspects, the present disclosure providesa non-transitory computer-readable medium storing computer-readableinstructions which, when executed, cause a machine to coordinate acontrol arrangement between surgical hubs, as described above.

Aspects of the present disclosure are presented for a surgical systemcomprising two independent surgical hubs that are configured to interactwith one another. Each of the hubs has their own linked surgical devicesand the control designation of and distribution of where data isrecorded and processed. This interaction causes one or both hubs tochange how they were behaving before the interaction. In one aspect, thechange involves a redistribution of devices previously assigned to eachof the hubs. In another aspect, the change involves establishing amaster-slave arrangement between the hubs. In yet another aspect, thechange can be a change in the location of the processing shared betweenthe hubs.

FIG. 53 is a logic flow diagram of a process depicting a control programor a logic configuration for coordinating a control arrangement betweensurgical hubs. The process of FIG. 53 is similar in many respects to theprocess of FIG. 35 except that the process of FIG. 53 addressesdetection of a surgical hub by another surgical hub. As illustrated inFIG. 53, the surgical hub 106 determines 3007 the bounds of theoperating room. After the initial determination, the surgical hub 106continuously searches for or detects 3008 devices within a pairingrange. If a device is detected 3010, and if the detected device islocated 3011 within the bounds of the operating room, the surgical hub106 pairs 3012 with the device and assigns 3013 an identifier to thedevice. If through an initial interaction, as described below in greaterdetail, the surgical hub 106 determines 3039 that the device is anothersurgical hub, a control arrangement is established 3040 therebetween.

Referring to FIG. 54, a robotic surgical hub 3300 enters an operatingroom already occupied by a surgical hub 3300. The robotic surgical hub3310 and the surgical hub 3300 are similar in many respects to othersurgical hubs described in greater detail elsewhere herein, such as, forexample, the surgical hubs 106. For example, the robotic surgical hub3310 includes non-contact sensors configured to measure the bounds ofthe operating room, as described in greater detail elsewhere herein inconnection with FIGS. 33, 34.

As the robotic surgical hub 3310 is powered up, it determines the boundsof the operating room and begins to pair with other components of thesurgical system 102 that are located within the bounds of the operatingroom. The robotic surgical hub 3310 pairs with a robotic advanced energytool 3311, a robotic stapler 3312, a monopolar energy tool 3313, and arobotic visualization tower 3314, which are all located within thebounds of the operating room. The surgical hub 3300 is already pairedwith a handheld stapler 3301, a handheld powered dissector 3302, asecondary display 3303, a surgeon interface 3304, and a visualizationtower 3305. Since the handheld stapler 3301, the handheld powereddissector 3302, the secondary display 3303, the surgeon interface 3304,and the visualization tower 3305 are already paired with the surgicalhub 3300, such devices cannot pair with another surgical hub withoutpermission from the surgical hub 3300.

Further to the above, the robotic surgical hub 3310 detects and/or isdetected by the surgical hub 3300. A communication link is establishedbetween the communication modules of the surgical hubs 3300, 3310. Thesurgical hubs 3300, 3310 then determine the nature of their interactionby determining a control arrangement therebetween. In one aspect, thecontrol arrangement can be a master-slave arrangement. In anotheraspect, the control arrangement can be a peer-to-peer arrangement.

In the example of FIG. 54, a master-slave arrangement is established.The surgical hubs 3300, 3310 request permission from a surgical operatorfor the robotic surgical hub 3310 to take control of the operating roomfrom the surgical hub 3300. The permission can be requested through asurgeon interface or console 3304. Once permission is granted, therobotic surgical hub 3310 requests the surgical hub 3300 to transfercontrol to the robotic surgical hub 3310.

Alternatively, the surgical hubs 3300, 3310 can negotiate the nature oftheir interaction without external input based on previously gathereddata. For example, the surgical hubs 3300, 3310 may collectivelydetermine that the next surgical task requires use of a robotic system.Such determination may cause the surgical hub 3300 to autonomouslysurrender control of the operating room to the robotic surgical hub3310. Upon completion of the surgical task, the robotic surgical hub3310 may then autonomously return the control of the operating room tosurgical hub 3300.

The outcome of the interaction between the surgical hubs 3300, 3310 isillustrated on the right of FIG. 54. The surgical hub 3300 hastransferred control to the robotic surgical hub 3310, which has alsotaken control of the surgeon interface 3304 and the secondary display3303 from the surgical hub 3300. The robotic surgical hub 3310 assignsnew identification numbers to the newly transferred devices. Thesurgical hub 3300 retains control the handheld stapler 3301, thehandheld powered dissector 3302, and visualization tower 3305. Inaddition, the surgical hub 3300 performs a supporting role, wherein theprocessing and storage capabilities of the surgical hub 3300 are nowavailable to the robotic surgical hub 3310.

FIG. 55 is a logic flow diagram of a process depicting a control programor a logic configuration for coordinating a control arrangement betweensurgical hubs. In various aspects, two independent surgical hubs willinteract with one another in a predetermined manner to assess the natureof their relationship. In one example, after establishing 3321 acommunication link, the surgical hubs exchange 3322 data packets. A datapacket may include type, identification number, and/or status of asurgical hub. A data packet may further include a record of devicesunder control of the surgical hub and/or any limited communicationconnections, such as data ports for other secondary operating roomdevices.

The control arrangement between the surgical hubs is then determined3323 based on input from a surgical operator or autonomously between thesurgical hubs. The surgical hubs may store instructions as to how todetermine a control arrangement therebetween. The control arrangementbetween two surgical hubs may depend on the type of surgical procedurebeing performed. The control arrangement between two surgical hubs maydepend on their types, identification information, and/or status. Thecontrol arrangement between two surgical hubs may depend on the devicespaired with the surgical hubs. The surgical hubs then redistribute 3324the devices of the surgical system 102 therebetween based upon thedetermined control arrangement.

In the master-slave arrangement, the record communication can beunidirectional from the slave hub to the master hub. The master hub mayalso require the slave hub to hand-off some of its wireless devices toconsolidate communication pathways. In one aspect, the slave hub can berelegated to a relay configuration with the master hub originating allcommands and recording all data. The slave hub can remain linked to themaster hub for a distributed sub-processing of the master hub commands,records, and/or controls. Such interaction expands the processingcapacity of the dual linked hubs beyond the capabilities of the masterhub by itself.

In a peer-to-peer arrangement, each surgical hub may retain control ofits devices. In one aspect, the surgical hubs may cooperate incontrolling a surgical instrument. In one aspect, an operator of thesurgical instrument may designate the surgical hub that will control thesurgical instrument at the time of its use.

Referring generally to FIGS. 56-61, the interaction between surgicalhubs can be extended beyond the bounds of the operating room. In variousaspects, surgical hubs in separate operating rooms may interact with oneanother within predefined limits. Depending on their relative proximity,surgical hubs in separate operating rooms may interact through anysuitable wired or wireless data communication network such as Bluetoothand WiFi. As used here, a “data communication network” represents anynumber of physical, virtual, or logical components, including hardware,software, firmware, and/or processing logic configured to support datacommunication between an originating component and a destinationcomponent, where data communication is carried out in accordance withone or more designated communication protocols over one or moredesignated communication media.

In various aspects, a first surgical operator in a first operating roommay wish to consult a second surgical operator in a second operatingroom, such as in case of an emergency. A temporary communication linkmay be established between the surgical hubs of the first and secondoperating room to facilitate the consult while the first and secondsurgical operators remain in their respective operating rooms.

The surgical operator being consulted can be presented with a consultrequest through the surgical hub in his/her operating room. If thesurgical operator accepts, he/she will have access to all the datacompiled by the surgical hub requesting the consult. The surgicaloperator may access all previously stored data, including a full historyof the procedure. In addition, a livestream of the surgical site at therequesting operating room can be transmitted through the surgical hubsto a display at the receiving operating room.

When a consult request begins, the receiving surgical hub begins torecord all received information in a temporarily storage location, whichcan be a dedicated portion of the storage array of the surgical hub. Atthe end of the consult, the temporary storage location is purged fromall the information. In one aspect, during a consult, the surgical hubrecords all accessible data, including blood pressure, ventilation data,oxygen stats, generator settings and uses, and all patient electronicdata. The recorded data will likely be more than the data stored by thesurgical hub during normal operation, which is helpful in providing thesurgical operator being consulted with as much information as possiblefor the consult.

Referring to FIG. 56, a non-limiting example of an interaction betweensurgical hubs in different operating rooms is depicted. FIG. 56 depictsan operating room OR 1 that includes a surgical system 3400 supporting athoracic segmentectomy and a second operating room OR 3 that includes asurgical system 3410 supporting a colorectal procedure. The surgicalsystem 3400 includes surgical hub 3401, surgical hub 3402, and roboticsurgical hub 3403. The surgical system 3400 further includes a personalinterface 3406, a primary display 3408, and secondary displays 3404,3405. The surgical system 3410 includes a surgical hub 3411 and asecondary display 3412. For clarity, several components of the surgicalsystems 3400, 3410 are removed.

In the example of FIG. 56, the surgical operator of OR 3 is requesting aconsult from the surgical operator of OR 1. A surgical hub 3411 of theOR 3 transmits the consult request to one of the surgical hubs of the OR1, such as the surgical hub 3401. In OR 1, the surgical hub 3401presents the request at a personal interface 3406 held by the surgicaloperator. The consult is regarding selecting an optimal location of acolon transection. The surgical operator of OR 1, through a personalinterface 3406, recommends an optimal location for the transection sitethat avoids a highly vascular section of the colon. The recommendationis transmitted in real time through the surgical hubs 3401, 3411.Accordingly, the surgical operator is able to respond to the consultrequest in real time without having to leave the sterile field of hisown operating room. The surgical operator requesting the consult alsodid not have to leave the sterile field of OR 3.

If the surgical hub 3401 is not in communication with the personalinterface 3406, it may relay the message to another surgical hub suchas, for example, the surgical hub 3402 or the robotic surgical hub 3403.Alternatively, the surgical hub 3401 may request control of the personalinterface 3406 from another surgical hub.

In any event, if the surgical operator of OR 1 decides to accept theconsult request, a livestream, or frames, of a surgical site 3413 of thecolorectal procedure of OR 3 is transmitted to OR 1 through a connectionestablished between the surgical hubs 3401, 3411, for example. FIG. 57illustrates a livestream of the surgical site 3413 displayed on asecondary display of OR 3. The surgical hubs 3401, 3411 cooperate totransmit the livestream of the surgical site of OR 3 to the personalinterface 3406 of the OR 1, as illustrated in FIG. 58.

Referring to FIGS. 59-61, the surgical operator may expand thelaparoscopic livestream from OR 3 onto the primary display 3405 in OR 1,for example, through the controls of the personal interface 3406. Thepersonal interface 3406 allows the surgical operator to select adestination for the livestream by presenting the surgical operator withicons that represent the displays that are available in OR 1, asillustrated in FIG. 60. Other navigation controls 3407 are available tothe surgical operator through the personal interface 3406, asillustrated in FIG. 61. For example, the personal interface 3406includes navigation controls for adjusting the livestream of thesurgical site of OR 3 in OR 1 by the surgical operator moving his or herfingers on the livestream displayed on the personal interface 3406. Tovisualize the high vasculature regions, the consulted surgical operatormay change the view of the livestream from OR 3 through the personalinterface 3406 to an advanced imaging screen. The surgical operator maythen manipulate the image in multiple planes to see the vascularizationusing a wide-angle multi-spectral view, for example.

As illustrated in FIG. 61, the surgical operator also has access to anarray of relevant information 3420, such as, for example, heart rate,blood pressure, ventilation data, oxygen stats, generator settings anduses, and all patient electronic data of the patient in OR 3.

Data Management and Collection

In one aspect the surgical hub provides data storage capabilities. Thedata storage includes creation and use of self-describing data includingidentification features, management of redundant data sets, and storageof the data in a manner of paired data sets which can be grouped bysurgery but not necessarily keyed to actual surgical dates and surgeonsto maintain data anonymity. The following description incorporates byreference all of the “hub” and “cloud” analytics system hardware andsoftware processing techniques to implement the specific data managementand collection techniques described hereinbelow, as incorporated byreference herein. FIGS. 62-80 will be described in the context of theinteractive surgical system 100 environment including a surgical hub106, 206 described in connection FIGS. 1-11 and intelligent instrumentsand generators described in connection with FIGS. 12-21.

Electronic Medical Record (EMR) Interaction

FIG. 62 is a diagram 4000 illustrating a technique for interacting witha patient Electronic Medical Record (EMR) database 4002, according toone aspect of the present disclosure. In one aspect, the presentdisclosure provides a method of embedding a key 4004 within the EMRdatabase 4002 located within the hospital or medical facility. A databarrier 4006 is provided to preserve patient data privacy and allows thereintegration of stripped and isolated data pairs, as describedhereinbelow, from the surgical hub 106, 206 or the cloud 104, 204, to bereassembled. A schematic diagram of the surgical hub 206 is describedgenerally in FIGS. 1-11 and in particular in FIGS. 9-10. Therefore, inthe description of FIG. 62, the reader is guided to FIG. 1-11 and inparticular FIGS. 9-10 for any implementation details of the surgical hub206 that may be omitted here for conciseness and clarity of disclosure.Returning to FIG. 62, the method allows the users full access to all thedata collected during a surgical procedure and patient informationstored in the form of electronic medical records 4012. The reassembleddata can be displayed on a monitor 4010 coupled to the surgical hub 206or secondary monitors but is not permanently stored on any surgical hubstorage device 248. The reassembled data is temporarily stored in astorage device 248 located either in the surgical hub 206 or the cloud204 and is deleted at the end of its use and overwritten to insure itcannot be recovered. The key 4004 in the EMR database 4002 is used toreintegrate anonymized hub data back into full integrated patientelectronic medical records 4012 data.

As shown in FIG. 62, the EMR database 4002 is located within thehospital data barrier 4006. The EMR database 4002 may be configured forstoring, retrieving, and managing associative arrays, or other datastructures known today as a dictionary or hash. Dictionaries contain acollection of objects, or records, which in turn have many differentfields within them, each containing data. The patient electronic medicalrecords 4012 may be stored and retrieved using a key 4004 that uniquelyidentifies the patient electronic medical record 4012, and is used toquickly find the data within the EMR database 4002. The key-value EMRdatabase 4002 system treats the data as a single opaque collection whichmay have different fields for every record.

Information from the EMR database 4002 may be transmitted to thesurgical hub 206 and the patient electronic medical records 4012 data isredacted and stripped before it is sent to an analytics system basedeither on the hub 206 or the cloud 204. An anonymous data file 4016 iscreated by redacting personal patient data and stripping relevantpatient data 4018 from the patient electronic medical record 4012. Asused herein, the redaction process includes deleting or removingpersonal patient information from the patient electronic medical record4012 to create a redacted record that includes only anonymous patientdata. A redacted record is a record from which sensitive patientinformation has been expunged. Un-redacted data may be deleted 4019. Therelevant patient data 4018 may be referred to herein asstripped/extracted data 4018. The relevant patient data 4018 is used bythe surgical hub 206 or cloud 204 processing engines for analyticpurposes and may be stored on the storage device 248 of the surgical hub206 or may be stored on the cloud 204 based analytics system storagedevice 205. The surgical hub anonymous data file 4016 can be rebuiltusing a key 4004 stored in the EMR database 4002 to reintegrate thesurgical hub anonymous data file 4016 back into a fully integratedpatient electronic medical record 4012. The relevant patient data 4018that is used in analytic processes may include information such as thepatient's diagnoses of emphysema, pre-operative treatment (e.g.,chemotherapy, radiation, blood thinner, blood pressure medication,etc.), typical blood pressures, or any data that alone cannot be used toascertain the identity of the patient. Data 4020 to be redacted includespersonal information removed from the patient electronic medical record4012, may include age, employer, body mass index (BMI), or any data thatcan be used to ascertain the identify of the patient. The surgical hub206 creates a unique anonymous procedure ID number (e.g., 380i4z), forexample, as described in FIG. 63. Within the EMR database 4002 locatedin the hospital data barrier 4006, the surgical hub 206 can reunite thedata in the anonymous data file 4016 stored on the surgical hub 206storage device 248 with the data in the patient electronic medicalrecord 4012 stored on the EMR database 4002 for surgeon review. Thesurgical hub 206 displays the combined patient electronic medical record4012 on a display or monitor 4010 coupled to the surgical hub 206.Ultimately, un-redacted data is deleted 4019 from the surgical hub 206storage 248.

Creation of a Hospital Data Barrier, Inside which the Data from Hubs canbe Compared Using Non-Anonymized Data and Outside of which the Data hasto be Stripped

In one aspect, the present disclosure provides a surgical hub 206 asdescribed in FIGS. 9 and 10, for example, where the surgical hub 206comprises a processor 244; and a memory 249 coupled to the processor244. The memory 249 stores instructions executable by the processor 244to interrogate a surgical instrument 235, retrieve a first data set fromthe surgical instrument 235, interrogate a medical imaging device 238,retrieve a second data set from the medical imaging device 238,associate the first and second data sets by a key, and transmit theassociated first and second data sets to a remote network, e.g., thecloud 204, outside of the surgical hub 206. The surgical instrument 235is a first source of patient data and the first data set is associatedwith a surgical procedure. The medical imaging device 238 is a secondsource of patient data and the second data set is associated with anoutcome of the surgical procedure. The first and second data records areuniquely identified by the key.

In another aspect, the surgical hub 206 provides a memory 249 storinginstructions executable by the processor 244 to retrieve the first dataset using the key, anonymize the first data set, retrieve the seconddata set using the key, anonymize the second data set, pair theanonymized first and second data sets, and determine success rate ofsurgical procedures grouped by the surgical procedure based on theanonymized paired first and second data sets.

In another aspect, the surgical hub 206 provides a memory 249 storinginstructions executable by the processor 244 to retrieve the anonymizedfirst data set, retrieve the anonymized second data set, and reintegratethe anonymized first and second data sets using the key.

In another aspect, the first and second data sets define first andsecond data payloads in respective first and second data packets.

In various aspects, the present disclosure provides a control circuit toassociate the first and second data sets by a key as described above. Invarious aspects, the present disclosure provides a non-transitorycomputer readable medium storing computer readable instructions which,when executed, causes a machine to associate the first and second datasets by a key as described above.

During a surgical procedure it would be desirable to monitor dataassociated with the surgical procedure to enable configuration andoperation of instruments used during the procedure to improve surgicaloutcomes. The technical challenge is to retrieve the data in a mannerthat maintains the anonymity of the patient to maintain privacy of thedata associated with the patient. The data may be used forconglomeration with other data without individualizing the data.

One solution provides a surgical hub 206 to interrogate an electronicmedical records database 4002 for patient electronic medical records4012 data, strip out desirable or relevant patient data 4018 from thepatient electronic medical record 4012, and redact any personalinformation that could be used to identify the patient. The redactiontechnique removes any information that could be used to correlate thestripped relevant patient data 4018 to a specific patient, surgery, ortime. The surgical hub 206 and the instruments 235 coupled to thesurgical hub 206 can then be configured and operated based on thestripped relevant patient data 4018.

As disclosed in connection with FIG. 62, extracting (or stripping)relevant patient data 4018 from a patient electronic medical record 4012while redacting any information that can be used to correlate thepatient with the surgery or a scheduled time of the surgery enables therelevant patient data 4018 to be anonymized. The anonymous data file4016 can then be sent to the cloud 204 for aggregation, processing, andmanipulation. The anonymous data file 4016 can be used to configure thesurgical instrument 235, or any of the modules shown in FIGS. 9 and 10or the surgical hub 206 during the surgery based on the extractedanonymous data file 4016.

In one aspect, a hospital data barrier 4006 is created such that insidethe data barrier 4006 data from various surgical hubs 206 can becompared using non-anonymized un-redacted data and outside the databarrier 4006 data from various surgical hubs 206 are stripped tomaintain anonymity and protect the privacy of the patient and thesurgeon. This aspect is discussed further in connection with FIG. 66.

In one aspect, the data from a surgical hub 206 can be exchanged betweensurgical hubs 206 (e.g., hub-to-hub, switch-to-switch, orrouter-to-router) to provide in-hospital analysis and display of thedata. FIG. 1 shows an example of multiple hubs 106 in communicationwhich each other and with the cloud 104. This aspect also is discussedfurther in connection with FIG. 66.

In another aspect, an artificial time measure is substituted for a realtime clock for all information stored internally within an instrument235, a robot located in a robot hub 222, a surgical hub 206, and/orhospital computer equipment. The anonymized data, which may includeanonymized patient and surgeon data, is transmitted to the server 213 inthe cloud 204 and it is stored in the cloud storage device 205 coupledto the server 213. The substitution of an artificial real time clockenables anonymizing the patient data and surgeon data while maintainingdata continuity. In one aspect, the instrument 235, robot hub 222,surgical hub 206, and/or the cloud 204 are configured to obscure patientidentification (ID) while maintaining data continuity. This aspect isdiscussed further in connection with FIG. 63.

Within the surgical hub 206, a local decipher key 4004 allowsinformation retrieved from the surgical hub 206 itself to reinstate thereal-time information from the anonymized data set located in theanonymous data file 4016. The data stored on the hub 206 or the cloud204, however, cannot be reinstated to real-time information from theanonymized data set in the anonymous data file 4016. The key 4004 isheld locally in the surgical hub 206 computer/storage device 248 in anencrypted format. The surgical hub 206 network processor ID is part ofthe decryption mechanism such that if the key 4004 and data is removed,the anonymized data set in the anonymous data file 4016 cannot berestored without being on the original surgical hub 206 computer/storagedevice 248.

Substituting Artificial Time Measure for Real Time Clock for allInternally Stored Information and Sent to the Cloud as a Means toAnonymizing the Patient and Surgeon Data

FIG. 63 illustrates a process 4030 of anonymizing a surgical procedureby substituting an artificial time measure for a real time clock for allinformation stored internally within the instrument, robot, surgicalhub, and/or hospital computer equipment, according to one aspect of thepresent disclosure. As shown in FIG. 63, the surgical procedure set-upstart time 4032 was scheduled to begin at an actual time of 11:31:14(EST) based on a real time clock. At the stated procedure set-up starttime 4032, the surgical hub 206 starts 4034 an artificial randomizedreal time clock timing scheme at artificial real time at 07:36:00. Thesurgical hub 206 then ultrasonically pings 4036 the operating theater(e.g., sends out a burst of ultrasound and listens for the echo when itbounces off the perimeter walls of an operating theater (e.g., a fixed,mobile, temporary, or field the operating room) as described inconnection with FIG. 64 to verify the size of the operating theater andto adjust short range wireless, e.g., Bluetooth, pairing distance limitsat artificial real time 07:36:01. At artificial real time 07:36:03, thesurgical hub 206 strips 4038 the relevant data and applies a time stampto the stripped data. At artificial real time 07:36:05, the surgical hub206 wakes up and begins pairing 4040 only devices located within theoperating theater as verified using the ultrasonic pinging 4036 process.

FIG. 64 illustrates ultrasonic pinging of an operating room wall todetermine a distance between a surgical hub and the operating room wall,in accordance with at least one aspect of the present disclosure. Withreference also to FIG. 2, the spatial awareness of the surgical hub 206and its ability to map an operating room for potential components of thesurgical system allows the surgical hub 206 to make autonomous decisionsabout whether to include or exclude such potential components as part ofthe surgical system, which relieves the surgical staff from dealing withsuch tasks. Furthermore, the surgical hub 206 is configured to makeinferences about, for example, the type of surgical procedure to beperformed in the operating room based on information gathered prior to,during, and/or after the performance of the surgical procedure. Examplesof gathered information include the types of devices that are broughtinto the operating room, time of introduction of such devices into theoperating room, and/or the devices sequence of activation.

In one aspect, the surgical hub 206 employs the operating-room mappingmodule, such as, for example, the non-contact sensor module 242 todetermine the bounds of the surgical theater (e.g., a fixed, mobile, ortemporary operating room or space) using either ultrasonic or lasernon-contact measurement devices.

Referring now to FIG. 64, ultrasound based non-contact sensors 3002 canbe employed to scan the operating theater by transmitting a burst ofultrasound and receiving the echo when it bounces off a perimeter wall3006 of an operating theater to determine the size of the operatingtheater and to adjust short range wireless, e.g., Bluetooth, pairingdistance limits. In one example, the non-contact sensors 3002 can bePing ultrasonic distance sensors, as illustrated in FIG. 64.

FIG. 64 shows how an ultrasonic sensor 3002 sends a brief chirp with itsultrasonic speaker 3003 and makes it possible for a micro-controller3004 of the operating-room mapping module to measure how long the echotakes to return to the ultrasonic sensor's ultrasonic microphone 3005.The micro-controller 3004 has to send the ultrasonic sensor 3002 a pulseto begin the measurement. The ultrasonic sensor 3002 then waits longenough for the micro-controller program to start a pulse input command.Then, at about the same time the ultrasonic sensor 3002 chirps a 40 kHztone, it sends a high signal to the micro-controller 3004. When theultrasonic sensor 3002 detects the echo with its ultrasonic microphone3005, it changes that high signal back to low. The micro-controller'spulse input command measures the time between the high and low changes,and stores it measurement in a variable. This value can be used alongwith the speed of sound in air to calculate the distance between thesurgical hub 106 and the operating-room wall 3006.

In one example, a surgical hub 206 can be equipped with four ultrasonicsensors 3002, wherein each of the four ultrasonic sensors is configuredto assess the distance between the surgical hub 206 and a wall of theoperating room 3000. A surgical hub 206 can be equipped with more orless than four ultrasonic sensors 3002 to determine the bounds of anoperating room.

Other distance sensors can be employed by the operating-room mappingmodule to determine the bounds of an operating room. In one example, theoperating-room mapping module can be equipped with one or morephotoelectric sensors that can be employed to assess the bounds of anoperating room. In one example, suitable laser distance sensors can alsobe employed to assess the bounds of an operating room. Laser basednon-contact sensors may scan the operating theater by transmitting laserlight pulses, receiving laser light pulses that bounce off the perimeterwalls of the operating theater, and comparing the phase of thetransmitted pulse to the received pulse to determine the size of theoperating theater and to adjust short range wireless, e.g., Bluetooth,pairing distance limits.

Stripping Out Data from Images and Connected Smart Instrument Data toAllow Conglomeration but not Individualization

In one aspect, the present disclosure provides a data stripping methodwhich interrogates the electronic patient records provided, extracts therelevant portions to configure and operate the surgical hub andinstruments coupled to the surgical hub, while anonymizing the surgery,patient, and all identifying parameters to maintain patient privacy.

With reference now back to FIG. 63 and also to FIGS. 1-11 to showinteraction with an interactive surgical system 100 environmentincluding a surgical hub 106, 206, once the size of the operatingtheater has been verified and Bluetooth pairing is complete, based onartificial real time, the computer processor 244 of the surgical hub 206begins stripping 4038 data received from the modules coupled to thesurgical hub 206. In one example, the processor 244 begins stripping4083 images received from the imaging module 238 and connected smartinstruments 235, for example. Stripping 4038 the data allowsconglomeration of the data but not individualization of the data. Thisenables stripping 4038 the data identifier, linking the data, andmonitoring an event while maintaining patient privacy by anonymizing thedata.

With reference to FIGS. 1-64, in one aspect, a data stripping 4038method is provided. In accordance with the data stripping 4038 method,the surgical hub 206 processor 244 interrogates the patient recordsstored in the surgical hub database 238 and extracts the relevantportions of the patient records to configure and operate the surgicalhub 206 and its instruments 235, robots, and other modular devices,e.g., modules. The data stripping 4038 method anonymizes the surgicalprocedure, patient, and all identifying parameters associated with thesurgical procedure. Stripping 4038 the data on the fly ensures that atno time the data is correlated to a specific patient, surgicalprocedure, surgeon, time or other possible identifier that can be usedto correlate the data.

The data may be stripped 4038 for compilation of the base information ata remote cloud 204 database storage device 205 coupled to the remoteserver 213. The data stored in the database storage device 248 can beused in advanced cloud based analytics, as described in U.S. ProvisionalPatent Application Ser. No. 62/611,340, filed Dec. 28, 2017, titledCLOUD-BASED MEDICAL ANALYTICS, which is incorporated herein by referencein its entirety. A copy of the information with data links intact alsocan be stored into the patient EMR database 4002 (FIG. 62). For example,the surgical hub 206 may import patient tissue irregularities orco-morbidities to add to an existing data set stored in the database248. The data may be stripped 4038 before the surgery and/or may bestripped 4038 as the data is transmitted to the cloud 204 databasestorage device 205 coupled to the remote server 213.

With continued reference to FIGS. 1-11 and 62-64, FIG. 65 is a diagram4050 depicting the process of importing patient electronic medicalrecords 4012 containing surgical procedure and relevant patient data4018 stored in the EMR database 4002, stripping 4038 the relevantpatient data 4018 from the imported medical records 4012, andidentifying 4060 smart device implications 4062, or inferences,according to one aspect of the present disclosure. As shown in FIG. 65,the patient electronic medical records 4012, containing informationstored in the patient EMR database 4002, are retrieved from the EMRdatabase 4002, imported into the surgical hub 206, and stored in thesurgical hub 206 storage device 248. Un-redacted data is removed ordeleted 4019 from the patient electronic medical records 4012 beforethey are stored in the surgical hub 206 storage device 248 as ananonymous data file 4016 (FIG. 62). The relevant patient data 4018 isthen stripped 4038 from the medical records 4012 to remove the desiredrelevant patient data 4018 and delete 4019 un-redacted data to maintainpatient anonymity. In the illustrated example, the stripped data 4058includes emphysema, high blood pressure, small lung cancer,warfarin/blood thinner, and/or radiation pretreatment. The stripped data4058 is employed to identify 4060 smart device implications whilemaintaining patient anonymity as described hereinbelow.

Although the surgical procedure data and relevant patient data 4018 isdescribed as being imported from patient electronic medical records 4012stored in the EMR database 4002, in various aspects, the surgicalprocedure data and relevant patient data 4018 may be retrieved from amodular device coupled to the surgical hub 206 before being stored inthe EMR database 4002. For example, the surgical hub 206 may interrogatethe module to retrieve the surgical procedure data and relevant patientdata 4018 from the module. As described herein, a module includes animaging module 238 that is coupled to an endoscope 239, a generatormodule 240 that is coupled to an energy device 241, a smoke evacuatormodule 226, a suction/irrigation module 228, a communication module 230,a processor module 232, a storage array 234, a smart device/instrument235 optionally coupled to a display 237, and a non-contact sensor module242, among other modules as illustrated in FIGS. 3 and 8-10.

For example, the anonymized stripped data 4058 may be employed toidentify 4060 catastrophic failures of instruments, and other smartdevices, and may initiate an automatic archive process and submission ofdata for further implications analysis. For example, the implication ofdetecting a counterfeit component or adapter on an original equipmentmanufacturer (OEM) device would be to initiate documentation of thecomponent and recording of the results and outcome of its use. Forexample, the surgical hub 206 may execute situational awarenessalgorithms as described in connection FIG. 86. In one aspect, thesurgical hub 206 may initially receive or identify a variety ofimplications 4062 that are derived from anonymized stripped data 4058.The surgical hub 206 is configured to control the instruments 235, orother modules, so that they operate correspondingly to the derivedimplications 4062. In one example, the surgical hub 206 control logicidentifies that (i) lung tissue may be more fragile than normal (e.g.,due to emphysema), (ii) hemostasis issues are more likely (e.g., due tohigh blood pressure and/or the patient being on a blood thinner, such aswarfarin), (iii) cancer may be more aggressive (e.g., due to the targetof the procedure being a small cell lung cancer), and (iv) lung tissuemay be stiffer and more prone to fracture (e.g., due to the patienthaving received a radiation pretreatment). The control logic orprocessor 244 of the surgical hub 206 then interprets how this dataimpacts the instruments 235, or other modules, so that the instruments235 are operated consistently with the data and then communicates thecorresponding adjustments to each of the instruments 235.

In one example relating to a stapler type of surgical instrument 235,based on the implications 4062 identified 4060 from the anonymizedstripped data 4058, the control logic or processor 244 of the surgicalhub 206 may (i) notify the stapler to adjust the compression ratethreshold parameter, (ii) adjust the surgical hub 206 visualizationthreshold value to quantify the bleeding and internal parameters, (iii)notify the combo generator module 240 of the lung tissue and vesseltissue types so that the power and generator module 240 controlalgorithms are adjusted accordingly, (iv) notify the imaging module 238of the aggressive cancer tag to adjust the margin ranges accordingly,(v) notify the stapler of the margin parameter adjustment needed (themargin parameter corresponds to the distance or amount of tissue aroundthe cancer that will be excised), and (vi) notify the stapler that thetissue is potentially fragile. Furthermore, the anonymized stripped data4058, upon which the implications 40602 are based, is identified by thesurgical hub 206 and is fed into the situational awareness algorithm(see FIG. 86). Examples include, without limitations, thoracic lungresection, e.g., segmentectomy, among others.

FIG. 66 is a diagram 4070 illustrating the application of cloud basedanalytics to un-redacted data, stripped relevant patient data 4018, andindependent data pairs, according to one aspect of the presentdisclosure. As shown, multiple surgical hubs Hub #1 4072, Hub #3 4074,and Hub #4 4076 are located within the hospital data barrier 4006 (seealso FIG. 62). The un-redacted patient electronic medical record 4012including patient data and surgery related data may be used andexchanged between the surgical hubs: Hub #1 4072, Hub #3 4074, and Hub#4 4076 located within the hospital data barrier 4006. Prior totransmitting the un-redacted patient electronic medical record 4012containing patient data and surgery related data outside the hospitaldata barrier 4006, however, the patient electronic medical record 4012patient data is redacted and stripped to create an anonymous data file4016 containing anonymized information for further analysis andprocessing of the redacted/stripped data by a cloud based analyticprocesses in the cloud 204.

FIG. 67 is a logic flow diagram 4080 of a process depicting a controlprogram or a logic configuration for associating patient data sets fromfirst and second sources of data, according to one aspect of the presentdisclosure. With reference to FIG. 67 and with reference also to FIGS.1-11 to show interaction with an interactive surgical system 100environment including a surgical hub 106, 206, in one aspect, thepresent disclosure provides a surgical hub 206, comprising a processor244; and a memory 249 coupled to the processor 244. The memory 249stores instructions executable by the processor 244 to interrogate 4082a surgical instrument 235, retrieve 4084 a first data set from thesurgical instrument 235, interrogate 4086 a medical imaging device 238,retrieve 4088 a second data set from the medical imaging device 238,associate 4090 the first and second data sets by a key, and transmit theassociated first and second data sets to a remote network outside of thesurgical hub 206. The surgical instrument 235 is a first source ofpatient data and the first data set is associated with a surgicalprocedure. The medical imaging device 238 is a second source of patientdata and the second data set is associated with an outcome of thesurgical procedure. The first and second data records are uniquelyidentified by the key.

In another aspect, the surgical hub 206 provides a memory 249 storinginstructions executable by the processor 244 to retrieve the first dataset using the key, anonymize the first data set, retrieve the seconddata set using the key, anonymize the second data set, pair theanonymized first and second data sets, and determine success rate ofsurgical procedures grouped by the surgical procedure based on theanonymized paired first and second data sets.

In another aspect, the surgical hub 206 provides a memory 249 storinginstructions executable by the processor 244 to retrieve the anonymizedfirst data set, retrieve the anonymized second data set, and reintegratethe anonymized first and second data sets using the key.

FIG. 68 is a logic flow diagram of a process 4400 depicting a controlprogram or a logic configuration for stripping data to extract relevantportions of the data to configure and operate the surgical hub 206 andmodules (e.g., instruments 235) coupled to the surgical hub 206,according to one aspect of the present disclosure. With reference toFIG. 68 and with reference also to FIGS. 1-11 to show interaction withan interactive surgical system 100 environment including a surgical hub106, 206, in one aspect, the surgical hub 206 may be configured tointerrogate a module coupled to surgical hub 206 for data, and strip thedata to extract relevant portions of the data to configure and operatethe surgical hub 206 and modules (e.g., instruments 235) coupled to thesurgical hub 206 and anonymize the surgery, patient, and otherparameters that can be used to identify the patient to maintain patientprivacy. According to the process 4400, in one aspect the presentdisclosure provides a surgical hub 206 including a processor 244, amodular communication hub 203 coupled to the processor 244, where themodular communication hub 203 is configured to connect modular deviceslocated in one or more operating theaters to the surgical hub 206. Theprocessor 244 is coupled to a memory 249, where the memory 249 storesinstructions executable by the processor 244 to cause the processor tointerrogate 4402 a modular device coupled to the processor 244 via themodular communication hub 203. The modular device is a source of datasets that include patient identity data and surgical procedure data. Theprocessor 244 receives 4404 a data set from the modular device. Theprocessor 244 discards 4406 the patient identity data and any portion ofthe surgical procedure data that identifies the patient from the dataset. The processor 244 extracts 4408 anonymous data from the data setand creates 4410 an anonymized data set. The processor 244 configures4412 the operation of the surgical hub 206 or the modular device basedon the anonymized data set.

In another aspect, where the anonymized data set includes catastrophicfailure of a modular device, the memory 249 stores instructionsexecutable by the processor 244 to initiate automatic archiving andsubmission of data for implications analysis based on the catastrophicfailure of the modular device. In another aspect, the memory 249 storesinstructions executable by the processor 244 to detect counterfeitcomponent information from the anonymized data set. In another aspect,the memory 249 stores instructions executable by the processor 244 toderive implications of the modular device from the anonymized data setand the memory 249 stores instructions executable by the processor 244to configure the modular device to operate based on the derivedimplications or to configure the surgical hub based on the derivedimplications. In another aspect, the memory 249 stores instructionsexecutable by the processor 244 to conglomerate the anonymized data. Inanother aspect, the memory 249 stores instructions executable by theprocessor 244 to extract the anonymized data prior to storing thereceived data in a storage device coupled to the surgical hub. Inanother aspect, the memory 249 stores instructions executable by theprocessor to transmit the anonymized data to a remote network outside ofthe surgical hub, compile the anonymized data at the remote network, andstore a copy of the data set from the modular device in a patientelectronic medical records database.

Storage of Data Creation and Use of Self-Describing Data IncludingIdentification Features

In one aspect, the present disclosure provides self-describing datapackets generated at the issuing instrument and including identifiersfor all devices that handled the packet. The self description allows theprocessor to interpret the data in the self-describing packet withoutknowing the data type in advance prior to receipt of the self-describingpacket. The data applies to every data point or data string and includesthe type of data, the source of the self-describing packet, the deviceidentification that generated the packet, the units, the time ofgeneration of the packet, and an authentication that the data containedin the packet is unaltered. When the processor (in the device or thesurgical hub) receives an unexpected packet and verifies the source ofthe packet, the processor alters the collection techniques to be readyfor any subsequent packets from that source.

With reference also to FIGS. 1-11 to show interaction with aninteractive surgical system 100 environment including a surgical hub106, 206, during a surgical procedure being performed in a surgical hub206 environment, the size and quantity of data being generated bysurgical devices 235 coupled to the surgical hub 206 can become quitelarge. Also, data exchanged between the surgical devices 235 and/or thesurgical hub 206 can become quite large.

One solution provides a techniques for minimizing the size of the dataand handling the data within a surgical hub 206 by generating aself-describing packet. The self-describing packet is initiallyassembled by the instrument 235 that generated it. The packet is thenordered and encrypted b generating an encryption certificate which isunique for each data packet. The data is then communicated from theinstrument 235 via encrypted wired or wireless protocols and stored onthe surgical hub 206 for processing and transmission to the cloud 204analytics engine. Each self-describing data packet includes anidentifier to identify the specific instrument that generated it and thetime it was generated. A surgical hub 206 identifier is added to thepacket when the packet is received by the surgical hub 206.

In one aspect, the present disclosure provides a surgical hub 206comprising a processor 244 and a memory 249 coupled to the processor244. The memory 249 storing instructions executable by the processor 244to receive a first data packet from a first source, receive a seconddata packet from a second source, associate the first and second datapackets, and generate a third data packet comprising the first andsecond data payloads. The first data packet comprises a first preamble,a first data payload, a source of the first data payload, and a firstencryption certificate. The first preamble defines the first datapayload and the first encryption certificate verifies the authenticityof the first data packet. The second data packet comprises a secondpreamble, a second data payload, a source of the second data payload,and a second encryption certificate. The second preamble defines thesecond data payload and the second encryption certificate verifies theauthenticity of the second data packet.

In another aspect, the memory 249 stores instructions executable by theprocessor 244 to determine that a data payload is from a new source,verify the new source of the data payload, and alter a data collectionprocess at the surgical hub to receive subsequent data packets from thenew source.

In another aspect, the memory 249 stores instructions executable by theprocessor 244 to associate the first and second data packets based on akey. In another aspect, the memory 249 stores instructions executable bythe processor 244 to anonymize the data payload of the third datapacket. In another aspect, the memory 249 stores instructions executableby the processor 244 to receive an anonymized third data packet andreintegrate the anonymized third data packet into the first and seconddata packets using the key.

In various aspects, the present disclosure provides a control circuit toreceive and process data packets as described above. In various aspects,the present disclosure provides a non-transitory computer-readablemedium storing computer readable instructions, which when executed,causes a machine to receive and process data packets as described above.

In other aspects, the present disclosure a method of generating a datapacket comprising self-describing data. In one aspect, a surgicalinstrument includes a processor and a memory coupled to the processor, acontrol circuit, and/or a computer-readable medium configured togenerate a data packet comprising a preamble, a data payload, a sourceof the data payload, and an encryption certificate. The preamble definesthe data payload and the encryption certificate verifies theauthenticity of the data packet. In various aspects, the data packet maybe generated by any module coupled to the surgical hub. Self-describingdata packets minimize data size and data handing in the surgical hub.

In one aspect, the present disclosure provides a self-describing datapacket generated at an issuing device (e.g., instrument, tool, robot).The self-describing data packet comprises identifiers for all devicesthat handle the data packet along a communication path; a selfdescription to enable a processor to interpret that data contained inthe data packet without having been told in advance of receipt of thedata packet along a path; data for every data point or data string; andtype of data, source of data, device IDs that generated the data, unitsof the data, time of generation, and authentication that the data packetis unaltered. In another aspect, when a processor receives a data packetfrom an unexpected source and verifies the source of the data, theprocessor alters the data collection technique to prepare for anysubsequent data packets from the source.

In the creation and use of a data packet comprising self-describingdata, the surgical hub includes identification features. The hub andintelligent devices use self-describing data packets to minimize datasize and data handling. In a surgical hub that generates large volumesof data, the self-describing data packets minimize data size and datahandling, thus saving time and enabling the operating theater to runmore efficiently.

FIG. 69 illustrates a self-describing data packet 4100 comprisingself-describing data, according to one aspect of the present disclosure.With reference also to FIGS. 1-11 to show interaction with aninteractive surgical system 100 environment including a surgical hub106, 206, in one aspect, self-describing data packets 4100 as shown inFIG. 69 are generated at an issuing instrument 235, or device or modulelocated in or in communication with the operating theater, and includeidentifiers for all devices 235 that handle the packet along acommunication path. The self description allows a processor 244 tointerpret the data payload of the packet 4100 without having advanceknowledge of the definition of the data payload prior to receiving theself-describing data packet 4100. The processor 244 can interpret thedata payload by parsing an incoming self-describing packet 4100 as it isreceived and identifying the data payload without being notified inadvance that the self-describing packet 4100 was received. The data isfor every data point or data string. The data payload includes type ofdata, source of data, device IDs that generated the data, data units,time when data was generated, and an authentication that theself-describing data packet 4100 is unaltered. Once the processor 244,which may be located either in the device or the surgical hub 206,receives an unexpected self-describing data packet 4100 and verifies thesource of the self-describing data packet 4100, the processor 244 altersthe data collection means to be ready for any subsequent self-describingdata packets 4100 from that source. In one example, the informationcontained in a self-describing packet 4100 may be recorded during thefirst firing 4172 in the lung tumor resection surgical proceduredescribed in connection with FIGS. 71-75.

The self-describing data packet 4100 includes not only the data but apreamble which defines what the data is and where the data came from aswell as an encryption certificate verifying the authenticity of eachdata packet 4100. As shown in FIG. 69, the data packet 4100 may comprisea self-describing data header 4102 (e.g., force-to-fire [FTF],force-to-close [FTC], energy amplitude, energy frequency, energy pulsewidth, speed of firing, and the like), a device ID 4104 (e.g., 002), ashaft ID 4106 (e.g., W30), a cartridge ID 4108 (e.g., ESN736), a uniquetime stamp 4110 (e.g., 09:35:15), a force-to-fire value 4112 (e.g., 85)when the self-describing data header 4102 includes FTF (force-to-fire),otherwise, this position in the data packet 4100 includes the value offorce-to-close, energy amplitude, energy frequency, energy pulse width,speed of firing, and the like. The data packet 4100, further includestissue thickness value 4114 (e.g., 1.1 mm), and an identificationcertificate of data value 4116 (e.g., 01101010001001) that is unique foreach data packet 4100. Once the self-describing data packet 4100 isreceived by another instrument 235, surgical hub 206, cloud 204, etc.,the receiver parses the self-describing data header 4102 and based onits value knows what data type is contained in the self-describing datapacket 4100. TABLE 1 below lists the value of the self-describing dataheader 4102 and the corresponding data value.

TABLE 1 Self-Describing Data Header (4102) Data Type FTF Force To Fire(N) FTC Force To Close (N) EA Energy Amplitude (J) EF Energy Frequency(Hz) EPW Energy Pulse Width (Sec) SOF Speed Of Firing (mm/sec)

Each self-describing data packet 4100 comprising self-describing data isinitially assembled by the instrument 235, device, or module thatgenerated the self-describing data packet 4100. Subsequently, theself-describing data packet 4100 comprising self-describing data isordered and encrypted to generate an encryption certificate. Theencryption certificate is unique for each self-describing data packet4100. That data is then communicated via encrypted wired or wirelessprotocols and stored on the surgical hub 206 for processing andtransmission to the cloud 204 analytics engine.

Each self-describing data packet 4100 comprising self-describing dataincludes a device ID 4104 to identify the specific instrument 235 thatgenerated the self-describing data packet 4100, a time stamp 4110 toindicate the time that the data packet 4100 was generated, and when theself-describing data packet 4100 is received by the surgical hub 206.The surgical hub 206 ID also may be added to the self-describing datapacket 4100.

Each of the self-describing data packets 4100 comprising self-describingdata may include a packet wrapper that defines the beginning of the datapacket 4100 and the end of the data packet 4100 including anyidentifiers necessary to forecast the number and order of the bits inthe self-describing data packet.

The surgical hub 206 also manages redundant data sets. As the device 235functions and interconnects with other surgical hubs 206, multiple setsof the same data may be created and stored on various devices 235.Accordingly, the surgical hub 206 manages multiple images of redundantdata as well as anonymization and security of data. The surgical hub 206also provides temporary visualization and communication, incidentmanagement, peer-to-peer processing or distributed processing, andstorage backup and protection of data.

FIG. 70 is a logic flow diagram 4120 of a process depicting a controlprogram or a logic configuration for using data packets comprisingself-describing data, according to one aspect of the present disclosure.With reference to FIGS. 1-69, in one aspect, the present disclosureprovides a surgical hub 206 comprising a processor 244 and a memory 249coupled to the processor 244. The memory 249 storing instructionsexecutable by the processor 244 to receive a first data packet from afirst source, receive a second data packet from a second source,associate the first and second data packets, and generate a third datapacket comprising the first and second data payloads. The first datapacket comprises a first preamble, a first data payload, a source of thefirst data payload, and a first encryption certificate. The firstpreamble defines the first data payload and the first encryptioncertificate verifies the authenticity of the first data packet. Thesecond data packet comprises a second preamble, a second data payload, asource of the second data payload, and a second encryption certificate.The second preamble defines the second data payload and the secondencryption certificate verifies the authenticity of the second datapacket.

In another aspect, the memory 249 stores instructions executable by theprocessor 244 to determine that a data payload is from a new source,verify the new source of the data payload, and alter a data collectionprocess at the surgical hub to receive subsequent data packets from thenew source.

In another aspect, the memory 249 stores instructions executable by theprocessor 244 to associate the first and second data packets based on akey. In another aspect, the memory 249 stores instructions executable bythe processor 244 to anonymize the data payload of the third datapacket. In another aspect, the memory 244 stores instructions executableby the processor 244 to receive an anonymized third data packet andreintegrate the anonymized third data packet into the first and seconddata packets using the key.

FIG. 71 is a logic flow diagram 4130 of a process depicting a controlprogram or a logic configuration for using data packets comprisingself-describing data, according to one aspect of the present disclosure.With reference to FIG. 71 and with reference also to FIGS. 1-11 to showinteraction with an interactive surgical system 100 environmentincluding a surgical hub 106, 206, in one aspect, the present disclosureprovides a surgical hub 206 comprising a processor 244 and a memory 249coupled to the processor 244. The memory 249 storing instructionsexecutable by the processor 244 to receive 4132 a first self-describingdata packet from a first data source, the first self-describing datapacket comprising a first preamble, a first data payload, a source ofthe first data payload, and a first encryption certificate. The firstpreamble defines the first data payload and the first encryptioncertificate verifies the authenticity of the first data packet. Thememory 249 storing instructions executable by the processor 244 to parse4134 the received first preamble and interpret 4136 the first datapayload based on the first preamble.

In various aspects, the memory 249 stores instructions executable by theprocessor 244 to receive a second self-describing data packet from asecond data source, the second self-describing data packet comprising asecond preamble, a second data payload, a source of the second datapayload, and a second encryption certificate. The second preambledefines the second data payload and the second encryption certificateverifies the authenticity of the second data packet. The memory 249storing instructions executable by the processor 244 to parse thereceived second preamble, interpret the second data payload based on thesecond preamble, associate the first and second self-describing datapackets, and generate a third self-describing data packet comprising thefirst and second data payloads. In one aspect, the memory storesinstructions executable by the processor to anonymize the data payloadof the third self-describing data packet.

In various aspects, the memory stores instructions executable by theprocessor to determine that a data payload was generated by a new datasource, verify the new data source of the data payload, and alter a datacollection process at the surgical hub to receive subsequent datapackets from the new data source. In one aspect, the memory storesinstructions executable by the processor to associate the first andsecond self-describing data packets based on a key. In another aspect,the memory stores instructions executable by the processor to receive ananonymized third self-describing data packet and reintegrate theanonymized third self-describing data packet into the first and secondself-describing data packets using the key.

Storage of the Data in a Manner of Paired Data Sets which can be Groupedby Surgery but not Necessarily Keyed to Actual Surgical Dates andSurgeons

In one aspect, the present disclosure provides a data pairing methodthat allows a surgical hub to interconnect a device measured parameterwith a surgical outcome. The data pair includes all the relevantsurgical data or patient qualifiers without any patient identifier data.The data pair is generated at two separate and distinct times. Thedisclosure further provides configuring and storing the data in such amanner as to be able to rebuild a chronological series of events ormerely a series of coupled but unconstrained data sets. The disclosurefurther provides storing data in an encrypted form and having predefinedbackup and mirroring to the cloud.

To determine the success or failure of a surgical procedure, data storedin a surgical instrument should be correlated with the outcome of thesurgical procedure while simultaneously anonymizing the data to protectthe privacy of the patient. One solution is to pair data associated witha surgical procedure, as recorded by the surgical instrument during thesurgical procedure, with data assessing the efficacy of the procedure.The data is paired without identifiers associated with surgery, patient,or time to preserve anonymity. The paired data is generated at twoseparate and distinct times.

In one aspect, the present disclosure provides a surgical hub configuredto communicate with a surgical instrument. The surgical hub comprises aprocessor and a memory coupled to the processor. The memory storinginstructions executable by the processor to receive a first data setassociated with a surgical procedure, receive a second data setassociated with the efficacy of the surgical procedure, anonymize thefirst and second data sets by removing information that identifies apatient, a surgery, or a scheduled time of the surgery, and store thefirst and second anonymized data sets to generate a data pair grouped bysurgery. The first data set is generated at a first time, the seconddata set is generated at a second time, and the second time is separateand distinct from the first time.

In another aspect, the memory stores instructions executable by theprocessor to reconstruct a series of chronological events based on thedata pair. In another aspect, the memory stores instructions executableby the processor to reconstruct a series of coupled but unconstraineddata sets based on the data pair. In another aspect, the memory storesinstructions executable by the processor to encrypt the data pair,define a backup format for the data pair, and mirror the data pair to acloud storage device.

In various aspects, the present disclosure provides a control circuit toreceive and process data sets as described above. In various aspects,the present disclosure provides a non-transitory computer-readablemedium storing computer readable instructions, which when executed,causes a machine to receive and process data sets as described above.

Storage of paired anonymous data enables the hospital or surgeon to usethe data pairs locally to link to specific surgeries or to store thedata pairs to analyze overall trends without extracting specific eventsin chronological manner.

In one aspect, the surgical hub provides user defined storage andconfiguration of data. Storage of the data may be made in a manner ofpaired data sets which can be grouped by surgery, but not necessarilykeyed to actual surgical dates and surgeons. This technique providesdata anonymity with regard to the patient and surgeon.

In one aspect, the present disclosure provides a data pairing method.The data pairing method comprises enabling a surgical hub tointerconnect a device measured parameter with an outcome, wherein a datapair includes all the relevant tissue or patient qualifiers without anyof the identifiers, wherein the data pair is generated at two distinctand separate times. In another aspect, the present disclosure provides adata configuration that includes whether the data is stored in such amanner as to enable rebuilding a chronological series of events ormerely a series of coupled but unconstrained data sets. In anotheraspect, the data may be stored in an encrypted form. The stored data maycomprise a predefined backup and mirroring to the cloud.

The data may be encrypted locally to the device. The data backup may beautomatic to an integrated load secondary storage device. The deviceand/or the surgical hub may be configured to maintain the time ofstorage of the data and compile and transmit the data to anotherlocation for storage, e.g., another surgical hub or a cloud storagedevice. The data may be grouped together and keyed for transmission tothe cloud analytics location. A cloud based analytics system isdescribed in commonly-owned U.S. Provisional Patent Application Ser. No.62/611,340, filed Dec. 28, 2017, titled CLOUD-BASED MEDICAL ANALYTICS,which is incorporated herein by reference in its entirety.

In another aspect, the hub provides user selectable options for storingthe data. In one technique, the hub enables the hospital or the surgeonto select if the data should be stored in such a manner that it could beused locally in a surgical hub to link to specific surgeries. In anothertechnique, the surgical hub enables the data to be stored as data pairsso that overall trends can be analyzed without specific events extractedin a chronological manner.

FIG. 72 is a diagram 4150 of a tumor 4152 embedded in the right superiorposterior lobe 4154 of the right lung 4156, according to one aspect ofthe present disclosure. To remove the tumor 4152, the surgeon cutsaround the tumor 4152 along the perimeter generally designated as amargin 4158. A fissure 4160 separates the upper lobe 4162 and the middlelobe 4164 of the right lung 4156. In order to cut out the tumor 4152about the margin 4158, the surgeon must cut the bronchial vessels 4166leading to and from the middle lobe 4164 and the upper lobe 4162 of theright lung 4156. The bronchial vessels 4166 must be sealed and cut usinga device such as a surgical stapler, electrosurgical instrument,ultrasonic instrument, a combo electrosurgical/ultrasonic instrument,and/or a combo stapler/electrosurgical device generally representedherein as the instrument/device 235 coupled to the surgical hub 206. Thedevice 235 is configured to record data as described above, which isformed as a data packet, encrypted, stored, and/or transmitted to aremote data storage device 105 and processed by the server 113 in thecloud 104. FIGS. 77 and 78 are diagrams that illustrate the right lung4156 and the bronchial tree 4250 embedded within the parenchyma tissueof the lung.

In one aspect, the data packet may be in the form of the self-describingdata 4100 described in connection with FIGS. 69-71. The self-describingdata packet 4100 will contain the information recorded by the device 235during the procedure. Such information may include, for example, aself-describing data header 4102 (e.g., force-to-fire [FTF],force-to-close [FTC], energy amplitude, energy frequency, energy pulsewidth, speed of firing, and the like) based on the particular variable.The device ID 4104 (e.g., 002) of the instrument/device 235 used in theprocedure including components of the instrument/device 235 such as theshaft ID 4106 (e.g., W30) and the cartridge ID 4108 (e.g., ESN736). Theself-describing packet 4100 also records a unique time stamp 4110 (e.g.,09:35:15) and procedural variables such as a force-to-fire value 4112(e.g., 85) when the self-describing data header 4102 includes FTF(force-to-fire), otherwise, this position in the data packet 4100includes the value of force-to-close (FTC), energy amplitude, energyfrequency, energy pulse width, speed of firing, and the like, as shownin TABLE 1, for example. The data packet 4100, further may includetissue thickness value 4114 (e.g., 1.1 mm), which in this example refersto the thickness of the bronchial vessel 4166 exposed in the fissure4160 that were sealed and cut. Finally, each self-describing packet 4100includes an identification certificate of data value 4116 (e.g.,01101010001001) that uniquely identifies each data packet 4100transmitted by the device/instrument 235 to the surgical hub 206,further transmitted from the surgical hub 206 to the cloud 204 andstored on the storage device 205 coupled to the server 213, and/orfurther transmitted to the robot hub 222 and stored.

The data transmitted by way of a self-describing data packet 4100 issampled by the instrument device 235 at a predetermined sample rate.Each sample is formed into a self-describing data packet 4100 which istransmitted to the surgical hub 206 and eventually is transmitted fromthe surgical hub 206 to the cloud 204. The samples may be stored locallyin the instrument device 235 prior to packetizing or may be transmittedon the fly. The predetermined sampling rate and transmission rate aredictated by communication traffic in the surgical hub 206 and may beadjusted dynamically to accommodate current bandwidth limitations.Accordingly, in one aspect, the instrument device 235 may record all thesamples taken during surgery and at the end of the procedure packetizeeach sample into a self-describing packet 4100 and transmit theself-describing packet 4100 to the surgical hub 206. In another aspect,the sampled data may be packetized as it is recorded and transmitted tothe surgical hub 206 on the fly.

FIG. 73 is a diagram 4170 of a lung tumor resection surgical procedureincluding four separate firings of a surgical stapler device 235 to sealand cut bronchial vessels 4166 exposed in the fissure 4160 leading toand from the upper and lower lobes 4162, 4164 of the right lung 4156shown in FIG. 72, according to one aspect of the present disclosure. Thesurgical stapler device 235 is identified by a Device ID “002”. The datafrom each firing of the surgical stapler device 235 is recorded andformed into a data packet 4100 comprising self-describing data as shownin FIG. 70. The self-describing data packet 4100 shown in FIG. 70 isrepresentative of the first firing of device “002” having a staplecartridge serial number of ESN736, for example. In the followingdescription, reference also is made to FIGS. 12-19 for descriptions ofvarious architectures of instruments/devices 235 that include aprocessor or a control circuit coupled to a memory for recording (e.g.,saving or storing) data collected during a surgical procedure.

The first firing 4172 is recorded at anonymous time 09:35:15. The firstfiring 4172 seals and severs a first bronchial vessel 4166 leading toand from the middle lobe 4164 and the upper lobe 4162 of the right lung4156 into a first portion 4166 a and a second portion 4166 b, where eachportion 4166 a, 4166 b is sealed by respective first and second staplelines 4180 a, 4180 b. Information associated with the first firing 4172,for example the information described in connection with FIG. 70, isrecorded in the surgical stapler device 235 memory and is used to builda first self-describing data packet 4100 described in connection withFIGS. 69-71. The first self-describing packet 4100 may be transmittedupon completion of the first firing 4172 or may be kept stored in thesurgical stapler device 235 memory until the surgical procedure iscompleted. Once transmitted by the surgical stapler device 235, thefirst self-describing data packet 4100 is received by the surgical hub206. The first self-describing data packet 4100 is anonymized bystripping and time stamping 4038 the data, as discussed, for example, inconnection with FIG. 63. After the lung resection surgical is completed,the integrity of the seals of the first and second staple lines 4182 a,4182 b will be evaluated as shown in FIG. 74, for example, and theresults of the evaluation will be paired with information associatedwith the first firing 4172.

The second firing 4174 seals and severs a second bronchial vessel of thebronchial vessels 4166 leading to and from the middle lobe 4164 and theupper lobe 4162 of the right lung 4156 into a first portion 4166 c and asecond portion 4166 d, where each portion 4166 c, 4166 d is sealed byfirst and second staple lines 4180 c, 4180 d. Information associatedwith the second firing 4174, for example the information described inconnection with FIGS. 69-71, is recorded in the surgical stapler device235 memory and is used to build a second self-describing data packet4100 described in connection with FIGS. 69-71. The secondself-describing data packet 4100 may be transmitted upon completion ofthe second firing 4174 or may be kept stored in the surgical staplerdevice 235 memory until the surgical procedure is completed. Oncetransmitted by the surgical stapler device 235, the secondself-describing data packet 4100 is received by the surgical hub 206.The second self-describing data packet 4100 is anonymized by strippingand time stamping 4038 the data as discussed, for example, in connectionwith FIG. 63. After the lung resection surgical is completed, theintegrity of the seals of the first and second staple lines 4182 c, 4182d will be evaluated as shown in FIG. 74, for example, and the results ofthe evaluation will be paired with information associated with thesecond firing 4174.

The third firing 4176 is recorded at anonymous time 09:42:12. The thirdfiring 4176 seals and severs an outer portion of the upper and middlelobes 4162, 4164 of the right lung 4156. First and second staple lines4182 a, 4182 b are used to seal the outer portion of the upper andmiddle lobes 4162, 4162. Information associated with the third firing4176, for example the information described in connection with FIGS.69-71, is recorded in the surgical stapler device 235 memory and is usedto build a third self-describing data packet 4100 described inconnection with FIGS. 69-71. The third self-describing packet 4100 maybe transmitted upon completion of the third firing 4176 or may be keptstored in the surgical stapler device 235 memory until the surgicalprocedure is completed. Once transmitted by the surgical stapler device235, the third self-describing data packet 4100 is received by thesurgical hub 206. The third self-describing data packet 4100 isanonymized by stripping and time stamping 4038 the data, as discussed,for example, in connection with FIG. 63. After the lung resectionsurgical is completed, the integrity of the seals of the first andsecond staple lines 4180 a, 4180 b will be evaluated as shown in FIG.74, for example, and the results of the evaluation will be paired withinformation associated with the third firing 4172.

The fourth firing 4178 seals and severs an inner portion of the upperand middle lobes 4162, 4162 of the right lung 4156. First and secondstaple lines 4182 c, 4182 d are used to seal the inner portions of theupper and middle lobes 4162, 4164. Information associated with thefourth firing 4178, for example the information described in connectionwith FIG. 70, is recorded in the surgical stapler device 235 memory andis used to build a fourth self-describing data packet 4100 described inconnection with FIGS. 69-71. The fourth self-describing packet 4100 maybe transmitted upon completion of the fourth firing 4178 or may be keptstored in the surgical stapler device 235 memory until the surgicalprocedure is completed. Once transmitted by the surgical stapler device235, the fourth self-describing data packet 4100 is received by thesurgical hub 206. The fourth self-describing data packet 4100 isanonymized by stripping and time stamping 4038 the data, as discussed,for example, in connection with FIG. 63. After the lung resectionsurgical is completed, the integrity of the seals of the first andsecond staple lines 4182 a, 4182 b will be evaluated as shown in FIG.74, for example, and the results of the evaluation will be paired withinformation associated with the fourth firing 4172.

FIG. 74 is a graphical illustration 4190 of a force-to-close (FTC)versus time curve 4192 and a force-to-fire (FTF) versus time curve 4194characterizing the first firing 4172 of device 002 shown in FIG. 73,according to one aspect of the present disclosure. The surgical staplerdevice 235 is identified as 002 with a 30 mm staple cartridge S/N ESN736with a PVS shaft S/N M3615N (Shaft ID W30). The surgical stapler device235 was used for the first firing 4172 to complete the lung resectionsurgical procedure shown in FIG. 73. As shown in FIG. 74, the peakforce-to-fire force of 85 N. is recorded at anonymous time 09:35:15.Algorithms in the surgical stapler device 235 determine a tissuethickness of about 1.1 mm. As described hereinbelow, the FTC versus timecurve 4192 and the FTF versus time curve 4194 characterizing the firstfiring 4172 of the surgical device 235 identified by ID 002 will bepaired with the outcome of the lung resection surgical procedure,transmitted to the surgical hub 206, anonymized, and either stored inthe surgical hub 206 or transmitted to the cloud 204 for aggregation,further processing, analysis, etc.

FIG. 75 is a diagram 4200 illustrating a staple line visualization laserDoppler to evaluate the integrity of staple line seals by monitoringbleeding of a vessel after a firing of a surgical stapler, according toone aspect of the present disclosure. A laser Doppler technique isdescribed in above under the heading “Advanced Imaging AcquisitionModule,” in U.S. Provisional Patent Application Ser. No. 62/611,341,filed Dec. 28, 2017, and titled INTERACTIVE SURGICAL PLATFORM, which ishereby incorporated by reference herein in its entirety. The laserDoppler provides an image 4202 suitable for inspecting seals along thestaple lines 4180 a, 4180 b, 4182 a and for visualizing bleeding 4206 ofany defective seals. Laser Doppler inspection of the first firing 4172of device 002 shows a defective seal at the first staple line 4180 a ofthe first portion 4166 a of the bronchial vessel sealed during the firstfiring 4172. The staple line 4180 a seal is bleeding 4206 out at avolume of 0.5 cc. The image 4202 is recorded at anonymous time 09:55:154204 and is paired with the force-to-close curve 4192 and force-to-firecurve 4194 shown in FIG. 74. The data pair set is grouped by surgery andis stored locally in the surgical hub 206 storage 248 and/or remotely tothe cloud 204 storage 205 for aggregation, processing, and analysis, forexample. For example, the cloud 204 analytics engine associates theinformation contained in the first self-describing packet 4100associated with the first firing 4172 and indicate that a defective sealwas produced at the staple line 4166 a. Over time, this information canbe aggregated, analyzed, and used to improve outcomes of the surgicalprocedure, such as, resection of a lung tumor, for example.

FIG. 76 illustrates two paired data sets 4210 grouped by surgery,according to one aspect of the present disclosure. The upper paired dataset 4212 is grouped by one surgery and a lower paired data set 4214grouped by another surgery. The upper paired data set 4212, for example,is grouped by the lung tumor resection surgery discussed in connectionwith FIGS. 73-76. Accordingly, the rest of the description of FIG. 76will reference information described in FIGS. 32-35 as well as FIGS.1-21 to show interaction with an interactive surgical system 100environment including a surgical hub 106, 206. The lower paired data set4214 is grouped by a liver tumor resection surgical procedure where thesurgeon treated parenchyma tissue. The upper paired data set isassociated with a failed staple line seal and the bottom paired data setis associated with a successful staple line seal. The upper and lowerpaired data sets 4212, 4214 are sampled by the instrument device 235 andeach sample formed into a self-describing data packet 4100 which istransmitted to the surgical hub 206 and eventually is transmitted fromthe surgical hub 206 to the cloud 204. The samples may be stored locallyin the instrument device 235 prior to packetizing or may be transmittedon the fly. Sampling rate and transmission rate are dictated bycommunication traffic in the surgical hub 206 and may be adjusteddynamically to accommodate current bandwidth limitations.

The upper paired data set 4212 includes a left data set 4216 recorded bythe instrument/device 235 during the first firing 4172 linked 4224 to aright data set 4218 recorded at the time the staple line seal 4180 a ofthe first bronchial vessel 4166 a was evaluated. The left data set 4216indicates a “Vessel” tissue type 4236 having a thickness 4238 of 1.1 mm.Also included in the left data set 4216 is the force-to-close curve 4192and force-to-fire curve 4194 versus time (anonymous real time) recordedduring the first firing 4172 of the lung tumor resection surgicalprocedure. The left data set 4216 shows that the force-to-fire peaked at85 Lbs. and recorded at anonymous real time 4240 t_(1a) (09:35:15). Theright data set 4218 depicts the staple line visualization curve 4228depicting leakage versus time. The right data set 4218 indicates that a“Vessel” tissue type 4244 having a thickness 4246 of 1.1 mm experienceda staple line 4180 a seal failure 4242. The staple line visualizationcurve 4228 depicts leakage volume (cc) versus time of the staple line4180 a seal. The staple line visualization curve 4228 shows that theleakage volume reached 0.5 cc, indicating a failed staple line 4180 aseal of the bronchial vessel 4166 a, recorded at anonymous time 4248(09:55:15).

The lower paired data set 4214 includes a left data set 4220 recorded bythe instrument/device 235 during a firing linked 4226 to a right dataset 4222 recorded at the time the staple line seal of the parenchymatissue was evaluated. The left data set 4220 indicates a “Parenchyma”tissue type 4236 having a thickness 4238 of 2.1 mm. Also included in theleft data set 4220 is the force-to-close curve 4230 and force-to-firecurve 4232 versus time (anonymous real time) recorded during the firstfiring of the liver tumor resection surgical procedure. The left dataset 4220 shows that the force-to-fire peaked at 100 Lbs. and recorded atanonymous real time 4240 t_(1b) (09:42:12). The right data set 4222depicts the staple line visualization curve 4228 depicting leakageversus time. The right data set 4234 indicates that a “Parenchyma”tissue type 4244 having a thickness 4246 of 2.2 mm experienced asuccessful staple line seal. The staple line visualization curve 4234depicts leakage volume (cc) versus time of the staple line seal. Thestaple line visualization curve 4234 shows that the leakage volume was0.0 cc, indicating a successful staple line seal of the parenchymatissue, recorded at anonymous time 4248 (10:02:12).

The paired date sets 4212, 4214 grouped by surgery are collected formany procedures and the data contained in the paired date sets 4212,4214 is recorded and stored in the cloud 204 storage 205 anonymously toprotect patient privacy, as described in connection with FIGS. 62-69. Inone aspect, the paired date sets 4212, 4214 data are transmitted fromthe instrument/device 235, or other modules coupled to the surgical hub206, to the surgical hub 206 and to the cloud 204 in the form of theself-describing packet 4100 as described in connection with FIGS. 71 and72 and surgical procedure examples described in connection with FIGS.72-76. The paired date sets 4212, 4214 data stored in the cloud 204storage 205 is analyzed in the cloud 204 to provide feedback to theinstrument/device 235, or other modules coupled to the surgical hub 206,notifying a surgical robot coupled to the robot hub 222, or the surgeon,that the conditions identified by the left data set ultimately lead toeither a successful or failed seal. As described in connection with FIG.76, the upper left data set 4216 led to a failed seal and the bottomleft data set 4220 led to a successful seal. This is advantageousbecause the information provided in a paired data set grouped by surgerycan be used to improve resection, transection, and creation ofanastomosis in a variety of tissue types. The information can be used toavoid pitfalls that may lead to a failed seal.

FIG. 77 is a diagram of the right lung 4156 and FIG. 78 is a diagram ofthe bronchial tree 4250 including the trachea 4252 and the bronchi 4254,4256 of the lungs. As shown in FIG. 77, the right lung 4156 is composedof three lobes divided into the upper lobe 4162, the middle lobe 4160,and the lower lobe 4165 separated by the oblique fissure 4167 andhorizontal fissure 4160. The left lung is composed of only two smallerlobes due to the position of heart. As shown in FIG. 78, inside eachlung, the right bronchus 4254 and the left bronchus 4256 divide intomany smaller airways called bronchioles 4258, greatly increasing surfacearea. Each bronchiole 4258 terminates with a cluster of air sacs calledalveoli 4260, where gas exchange with the bloodstream occurs.

FIG. 79 is a logic flow diagram 4300 of a process depicting a controlprogram or a logic configuration for storing paired anonymous data setsgrouped by surgery, according to one aspect of the present disclosure.With reference to FIGS. 1-79, in one aspect, the present disclosureprovides a surgical hub 206 configured to communicate with a surgicalinstrument 235. The surgical hub 206 comprises a processor 244 and amemory 249 coupled to the processor 244. The memory 249 storinginstructions executable by the processor 244 to receive 4302 a firstdata set from a first source, the first data set associated with asurgical procedure, receive 4304 a second data set from a second source,the second data set associated with the efficacy of the surgicalprocedure, anonymize 4306 the first and second data sets by removinginformation that identifies a patient, a surgery, or a scheduled time ofthe surgery, and store 4308 the first and second anonymized data sets togenerate a data pair grouped by surgery. The first data set is generatedat a first time, the second data set is generated at a second time, andthe second time is separate and distinct from the first time.

In another aspect, the memory 249 stores instructions executable by theprocessor 244 to reconstruct a series of chronological events based onthe data pair. In another aspect, the memory 249 stores instructionsexecutable by the processor 244 to reconstruct a series of coupled butunconstrained data sets based on the data pair. In another aspect, thememory 249 stores instructions executable by the processor 244 toencrypt the data pair, define a backup format for the data pair, andmirror the data pair to a cloud 204 storage device 205.

Determination of Data to Transmit to Cloud Based Medical Analytics

In one aspect, the present disclosure provides a communication hub andstorage device for storing parameters and status of a surgical devicewhat has the ability to determine when, how often, transmission rate,and type of data to be shared with a cloud based analytics system. Thedisclosure further provides techniques to determine where the analyticssystem communicates new operational parameters for the hub and surgicaldevices.

In a surgical hub environment, large amounts of data can be generatedrather quickly and may cause storage and communication bottlenecks inthe surgical hub network. One solution may include local determinationof when and what data is transmitted for to the cloud-based medicalanalytics system for further processing and manipulation of surgical hubdata. The timing and rate at which the surgical hub data is exported canbe determined based on available local data storage capacity. Userdefined inclusion or exclusion of specific users, patients, orprocedures enable data sets to be included for analysis or automaticallydeleted. The time of uploads or communications to the cloud-basedmedical analytics system may be determined based on detected surgicalhub network down time or available capacity.

With reference to FIGS. 1-79, in one aspect, the present disclosureprovides a surgical hub 206 comprising a storage device 248, a processor244 coupled to the storage device 248, and a memory 249 coupled to theprocessor 244. The memory 249 stores instructions executable by theprocessor 244 to receive data from a surgical instrument 235, determinea rate at which to transfer the data to a remote cloud-based medicalanalytics network 204 based on available storage capacity of the storagedevice 248, determine a frequency at which to transfer the data to theremote cloud-based medical analytics network 204 based on the availablestorage capacity of the storage device 248 or detected surgical hubnetwork 206 down time, and determine a type of data to transfer the datato a remote cloud-based medical analytics network 204 based on inclusionor exclusion of data associated with a users, patient, or surgicalprocedure.

In another aspect, the memory 249 stores instructions executable by theprocessor 244 to receive new operational parameters for the surgical hub206 or the surgical instrument 235.

In various aspects, the present disclosure provides a control circuit todetermine, rate, frequency and type of data to transfer the data to theremote cloud-based medical analytics network as described above. Invarious aspects, the present disclosure provides a non-transitorycomputer-readable medium storing computer readable instructions which,when executed, causes a machine to determine, rate, frequency and typeof data to transfer to the remote cloud-based medical analytics network.

In one aspect, the surgical hub 206 is configured to determine what datato transmit to the cloud based analytics system 204. For example, asurgical hub 206 modular device 235 that includes local processingcapabilities may determine the rate, frequency, and type of data to betransmitted to the cloud based analytics system 204 for analysis andprocessing.

In one aspect, the surgical hub 206 comprises a modular communicationhub 203 and storage device 248 for storing parameters and status of adevice 235 that has the ability to determine when and how often data canbe shared with a cloud based analytics system 204, the transmission rateand the type of data that can be shared with the cloud based analyticssystem 204. In another aspect, the cloud analytics system 204communicates new operational parameters for the surgical hub 206 andsurgical devices 235 coupled to the surgical hub 206. A cloud basedanalytics system 204 is described in commonly-owned U.S. ProvisionalPatent Application Ser. No. 62/611,340, filed Dec. 28, 2017, and titledCLOUD-BASED MEDICAL ANALYTICS, which is incorporated herein by referencein its entirety.

In one aspect, a device 235 coupled to a local surgical hub 206determines when and what data is transmitted to the cloud analyticssystem 204 for company analytic improvements. In one example, theavailable local data storage capacity remaining in the storage device248 controls the timing and rate at which the data is exported. Inanother example, user defined inclusion or exclusion of specific users,patients, or procedures allows data sets to be included for analysis orautomatically deleted. In yet another example, detected network downtime or available capacity determines the time of uploads orcommunications.

In another aspect, transmission of data for diagnosis of failure modesis keyed by specific incidents. For example, user defined failure of adevice, instrument, or tool within a procedure initiates archiving andtransmission of data recorded with respect to that instrument forfailure modes analysis. Further, when a failure event is identified, allthe data surrounding the event is archived and packaged for sending backfor predictive informatics (PI) analytics. Data that is part of a PIfailure is flagged for storage and maintenance until either the hospitalor the cloud based analytics system releases the hold on the data.

Catastrophic failures of instruments may initiate an automatic archiveand submission of data for implications analysis. Detection of acounterfeit component or adapter on an original equipment manufacturer(OEM) device initiates documentation of the component and recording ofthe results and outcome of its use.

FIG. 80 is a logic flow diagram 4320 of a process depicting a controlprogram or a logic configuration for determining rate, frequency, andtype of data to transfer to a remote cloud-based analytics network,according to one aspect of the present disclosure. With reference toFIGS. 1-80, in one aspect, the present disclosure provides a surgicalhub 206 comprising a storage device 248, a processor 244 coupled to thestorage device 248, and a memory 249 coupled to the processor 244. Thememory 249 stores instructions executable by the processor 244 toreceive 4322 data from a surgical instrument 235, determine 4324 a rateat which to transfer the data to a remote cloud-based medical analyticsnetwork 204 based on available storage capacity of the storage device248. Optionally, the memory 249 stores instructions executable by theprocessor 244 to determine 4326 a frequency at which to transfer thedata to the remote cloud-based medical analytics network 204 based onthe available storage capacity of the storage device 248. Optionally,the memory 249 stores instructions executable by the processor 244 todetect surgical hub network downtime and to determine 4326 a frequencyat which to transfer the data to the remote cloud-based medicalanalytics network 204 based on the detected surgical hub network 206down time. Optionally, the memory 249 stores instructions executable bythe processor 244 to determine 4328 a type of data to transfer the datato a remote cloud-based medical analytics network 204 based on inclusionor exclusion of data associated with a users, patient, or surgicalprocedure.

In another aspect, the memory 249 stores instructions executable by theprocessor 244 to receive new operational parameters for the surgical hub206 or the surgical instrument 235.

In one aspect, the present disclosure provides a surgical hub,comprising: a processor; and a memory coupled to the processor, thememory storing instructions executable by the processor to: interrogatea surgical instrument, wherein the surgical instrument is a first sourceof patient data; retrieve a first data set from the surgical instrument,wherein the first data set is associated with a patient and a surgicalprocedure; interrogate a medical imaging device, wherein the medicalimaging device is a second source of patient data; retrieve a seconddata set from the medical imaging device, wherein the second data set isassociated with the patient and an outcome of the surgical procedure;associate the first and second data sets by a key; and transmit theassociated first and second data sets to remote network outside of thesurgical hub. The present disclosure further provides, a surgical hubwherein the memory stores instructions executable by the processor to:retrieve the first data set using the key; anonymize the first data setby removing its association with the patient; retrieve the second dataset using the key; anonymize the second data set by removing itsassociation with the patient; pair the anonymized first and second datasets; and determine success rates of surgical procedures grouped by thesurgical procedure based on the anonymized paired first and second datasets. The present disclosure further provides a surgical hub, whereinthe memory stores instructions executable by the processor to: retrievethe anonymized first data set; retrieve the anonymized second data set;and reintegrate the anonymized first and second data sets using the key.The present disclosure further provides a surgical hub, wherein thefirst and second data sets define first and second data payloads inrespective first and second data packets. The present disclosure furtherprovides a control circuit to perform any one of the above recitedfunctions and/or a non-transitory computer readable medium storingcomputer readable instructions which, when executed, causes a machine toperform any one of the above recited functions.

In another aspect, the present disclosure provides a surgical hub,comprising: a processor; and a memory coupled to the processor, thememory storing instructions executable by the processor to: receive afirst data packet from a first source, the first data packet comprisinga first preamble, a first data payload, a source of the first datapayload, and a first encryption certificate, wherein the first preambledefines the first data payload and the first encryption certificateverifies the authenticity of the first data packet; receive a seconddata packet from a second source, the second data packet comprising asecond preamble, a second data payload, a source of the second datapayload, and a second encryption certificate, wherein the secondpreamble defines the second data payload and the second encryptioncertificate verifies the authenticity of the second data packet;associate the first and second data packets; and generate a third datapacket comprising the first and second data payloads. The presentdisclosure further provides a surgical hub, wherein the memory storesinstructions executable by the processor to: determine that a datapayload is from a new source; verify the new source of the data payload;and alter a data collection process at the surgical hub to receivesubsequent data packets from the new source. The present disclosurefurther provides a surgical, wherein the memory stores instructionsexecutable by the processor to associate the first and second datapackets based on a key. The present disclosure further provides asurgical hub, wherein the memory stores instructions executable by theprocessor to anonymize the data payload of the third data packet. Thepresent disclosure further provides a surgical hub, wherein the memorystores instructions executable by the processor to receive an anonymizedthird data packet and reintegrate the anonymized third data packet intothe first and second data packets using the key. The present disclosurefurther provides a control circuit to perform any one of the aboverecited functions and/or a non-transitory computer readable mediumstoring computer readable instructions which, when executed, causes amachine to perform any one of the above recited functions.

In another aspect, the present disclosure provides a surgical hubconfigured to communicate with a surgical instrument, the surgical hubcomprising: a processor; and a memory coupled to the processor, thememory storing instructions executable by the processor to: receive afirst data set associated with a surgical procedure, wherein the firstdata set is generated at a first time; receive a second data setassociated with the efficacy of the surgical procedure, wherein thesecond data set is generated at a second time, wherein the second timeis separate and distinct from the first time; anonymize the first andsecond data sets by removing information that identifies a patient, asurgery, or a scheduled time of the surgery; and store the first andsecond anonymized data sets to generate a data pair grouped by surgery.The present disclosure further provides a surgical hub, wherein thememory stores instructions executable by the processor to reconstruct aseries of chronological events based on the data pair. The presentdisclosure further provides a surgical hub, wherein the memory storesinstructions executable by the processor to reconstruct a series ofcoupled but unconstrained data sets based on the data pair. The presentdisclosure further provides a surgical hub, wherein the memory storesinstructions executable by the processor to: encrypt the data pair;define a backup format for the data pair; and mirror the data pair to acloud storage device. The present disclosure further provides a controlcircuit to perform any one of the above recited functions and/or anon-transitory computer readable medium storing computer readableinstructions which, when executed, causes a machine to perform any oneof the above recited functions.

In another aspect, the present disclosure provides a surgical hubcomprising: a storage device; a processor coupled to the storage device;and a memory coupled to the processor, the memory storing instructionsexecutable by the processor to: receive data from a surgical instrument;determine a rate at which to transfer the data to a remote cloud-basedmedical analytics network based on available storage capacity of thestorage device; determine a frequency at which to transfer the data tothe remote cloud-based medical analytics network based on the availablestorage capacity of the storage device or detected surgical hub networkdown time; and determine a type of data to transfer the data to a remotecloud-based medical analytics network based on inclusion or exclusion ofdata associated with a users, patient, or surgical procedure. Thepresent disclosure further provides a surgical hub, wherein the memorystores instructions executable by the processor to receive newoperational parameters for the surgical hub or the surgical instrument.The present disclosure further provides a control circuit to perform anyone of the above recited functions and/or a non-transitory computerreadable medium storing computer readable instructions which, whenexecuted, causes a machine to perform any one of the above recitedfunctions.

In another aspect, the present disclosure provides a surgical hubcomprising: a control configured to: receive data from a surgicalinstrument; determine a rate at which to transfer the data to a remotecloud-based medical analytics network based on available storagecapacity of the storage device; determine a frequency at which totransfer the data to the remote cloud-based medical analytics networkbased on the available storage capacity of the storage device ordetected surgical hub network down time; and determine a type of data totransfer the data to a remote cloud-based medical analytics networkbased on inclusion or exclusion of data associated with a users,patient, or surgical procedure.

Surgical Hub Situational Awareness

Although an “intelligent” device including control algorithms thatrespond to sensed data can be an improvement over a “dumb” device thatoperates without accounting for sensed data, some sensed data can beincomplete or inconclusive when considered in isolation, i.e., withoutthe context of the type of surgical procedure being performed or thetype of tissue that is being operated on. Without knowing the proceduralcontext (e.g., knowing the type of tissue being operated on or the typeof procedure being performed), the control algorithm may control themodular device incorrectly or suboptimally given the particularcontext-free sensed data. For example, the optimal manner for a controlalgorithm to control a surgical instrument in response to a particularsensed parameter can vary according to the particular tissue type beingoperated on. This is due to the fact that different tissue types havedifferent properties (e.g., resistance to tearing) and thus responddifferently to actions taken by surgical instruments. Therefore, it maybe desirable for a surgical instrument to take different actions evenwhen the same measurement for a particular parameter is sensed. As onespecific example, the optimal manner in which to control a surgicalstapling and cutting instrument in response to the instrument sensing anunexpectedly high force to close its end effector will vary dependingupon whether the tissue type is susceptible or resistant to tearing. Fortissues that are susceptible to tearing, such as lung tissue, theinstrument's control algorithm would optimally ramp down the motor inresponse to an unexpectedly high force to close to avoid tearing thetissue. For tissues that are resistant to tearing, such as stomachtissue, the instrument's control algorithm would optimally ramp up themotor in response to an unexpectedly high force to close to ensure thatthe end effector is clamped properly on the tissue. Without knowingwhether lung or stomach tissue has been clamped, the control algorithmmay make a suboptimal decision.

One solution utilizes a surgical hub including a system that isconfigured to derive information about the surgical procedure beingperformed based on data received from various data sources and thencontrol the paired modular devices accordingly. In other words, thesurgical hub is configured to infer information about the surgicalprocedure from received data and then control the modular devices pairedto the surgical hub based upon the inferred context of the surgicalprocedure. FIG. 81 illustrates a diagram of a situationally awaresurgical system 5100, in accordance with at least one aspect of thepresent disclosure. In some exemplifications, the data sources 5126include, for example, the modular devices 5102 (which can includesensors configured to detect parameters associated with the patientand/or the modular device itself), databases 5122 (e.g., an EMR databasecontaining patient records), and patient monitoring devices 5124 (e.g.,a blood pressure (BP) monitor and an electrocardiography (EKG) monitor).The surgical hub 5104 can be configured to derive the contextualinformation pertaining to the surgical procedure from the data basedupon, for example, the particular combination(s) of received data or theparticular order in which the data is received from the data sources5126. The contextual information inferred from the received data caninclude, for example, the type of surgical procedure being performed,the particular step of the surgical procedure that the surgeon isperforming, the type of tissue being operated on, or the body cavitythat is the subject of the procedure. This ability by some aspects ofthe surgical hub 5104 to derive or infer information related to thesurgical procedure from received data can be referred to as “situationalawareness.” In one exemplification, the surgical hub 5104 canincorporate a situational awareness system, which is the hardware and/orprogramming associated with the surgical hub 5104 that derivescontextual information pertaining to the surgical procedure from thereceived data.

The situational awareness system of the surgical hub 5104 can beconfigured to derive the contextual information from the data receivedfrom the data sources 5126 in a variety of different ways. In oneexemplification, the situational awareness system includes a patternrecognition system, or machine learning system (e.g., an artificialneural network), that has been trained on training data to correlatevarious inputs (e.g., data from databases 5122, patient monitoringdevices 5124, and/or modular devices 5102) to corresponding contextualinformation regarding a surgical procedure. In other words, a machinelearning system can be trained to accurately derive contextualinformation regarding a surgical procedure from the provided inputs. Inanother exemplification, the situational awareness system can include alookup table storing pre-characterized contextual information regardinga surgical procedure in association with one or more inputs (or rangesof inputs) corresponding to the contextual information. In response to aquery with one or more inputs, the lookup table can return thecorresponding contextual information for the situational awarenesssystem for controlling the modular devices 5102. In one exemplification,the contextual information received by the situational awareness systemof the surgical hub 5104 is associated with a particular controladjustment or set of control adjustments for one or more modular devices5102. In another exemplification, the situational awareness systemincludes a further machine learning system, lookup table, or other suchsystem, which generates or retrieves one or more control adjustments forone or more modular devices 5102 when provided the contextualinformation as input.

A surgical hub 5104 incorporating a situational awareness systemprovides a number of benefits for the surgical system 5100. One benefitincludes improving the interpretation of sensed and collected data,which would in turn improve the processing accuracy and/or the usage ofthe data during the course of a surgical procedure. To return to aprevious example, a situationally aware surgical hub 5104 coulddetermine what type of tissue was being operated on; therefore, when anunexpectedly high force to close the surgical instrument's end effectoris detected, the situationally aware surgical hub 5104 could correctlyramp up or ramp down the motor of the surgical instrument for the typeof tissue.

As another example, the type of tissue being operated can affect theadjustments that are made to the compression rate and load thresholds ofa surgical stapling and cutting instrument for a particular tissue gapmeasurement. A situationally aware surgical hub 5104 could infer whethera surgical procedure being performed is a thoracic or an abdominalprocedure, allowing the surgical hub 5104 to determine whether thetissue clamped by an end effector of the surgical stapling and cuttinginstrument is lung (for a thoracic procedure) or stomach (for anabdominal procedure) tissue. The surgical hub 5104 could then adjust thecompression rate and load thresholds of the surgical stapling andcutting instrument appropriately for the type of tissue.

As yet another example, the type of body cavity being operated in duringan insufflation procedure can affect the function of a smoke evacuator.A situationally aware surgical hub 5104 could determine whether thesurgical site is under pressure (by determining that the surgicalprocedure is utilizing insufflation) and determine the procedure type.As a procedure type is generally performed in a specific body cavity,the surgical hub 5104 could then control the motor rate of the smokeevacuator appropriately for the body cavity being operated in. Thus, asituationally aware surgical hub 5104 could provide a consistent amountof smoke evacuation for both thoracic and abdominal procedures.

As yet another example, the type of procedure being performed can affectthe optimal energy level for an ultrasonic surgical instrument or radiofrequency (RF) electrosurgical instrument to operate at. Arthroscopicprocedures, for example, require higher energy levels because the endeffector of the ultrasonic surgical instrument or RF electrosurgicalinstrument is immersed in fluid. A situationally aware surgical hub 5104could determine whether the surgical procedure is an arthroscopicprocedure. The surgical hub 5104 could then adjust the RF power level orthe ultrasonic amplitude of the generator (i.e., “energy level”) tocompensate for the fluid filled environment. Relatedly, the type oftissue being operated on can affect the optimal energy level for anultrasonic surgical instrument or RF electrosurgical instrument tooperate at. A situationally aware surgical hub 5104 could determine whattype of surgical procedure is being performed and then customize theenergy level for the ultrasonic surgical instrument or RFelectrosurgical instrument, respectively, according to the expectedtissue profile for the surgical procedure. Furthermore, a situationallyaware surgical hub 5104 can be configured to adjust the energy level forthe ultrasonic surgical instrument or RF electrosurgical instrumentthroughout the course of a surgical procedure, rather than just on aprocedure-by-procedure basis. A situationally aware surgical hub 5104could determine what step of the surgical procedure is being performedor will subsequently be performed and then update the control algorithmsfor the generator and/or ultrasonic surgical instrument or RFelectrosurgical instrument to set the energy level at a valueappropriate for the expected tissue type according to the surgicalprocedure step.

As yet another example, data can be drawn from additional data sources5126 to improve the conclusions that the surgical hub 5104 draws fromone data source 5126. A situationally aware surgical hub 5104 couldaugment data that it receives from the modular devices 5102 withcontextual information that it has built up regarding the surgicalprocedure from other data sources 5126. For example, a situationallyaware surgical hub 5104 can be configured to determine whetherhemostasis has occurred (i.e., whether bleeding at a surgical site hasstopped) according to video or image data received from a medicalimaging device. However, in some cases the video or image data can beinconclusive. Therefore, in one exemplification, the surgical hub 5104can be further configured to compare a physiologic measurement (e.g.,blood pressure sensed by a BP monitor communicably connected to thesurgical hub 5104) with the visual or image data of hemostasis (e.g.,from a medical imaging device 124 (FIG. 2) communicably coupled to thesurgical hub 5104) to make a determination on the integrity of thestaple line or tissue weld. In other words, the situational awarenesssystem of the surgical hub 5104 can consider the physiologicalmeasurement data to provide additional context in analyzing thevisualization data. The additional context can be useful when thevisualization data may be inconclusive or incomplete on its own.

Another benefit includes proactively and automatically controlling thepaired modular devices 5102 according to the particular step of thesurgical procedure that is being performed to reduce the number of timesthat medical personnel are required to interact with or control thesurgical system 5100 during the course of a surgical procedure. Forexample, a situationally aware surgical hub 5104 could proactivelyactivate the generator to which an RF electrosurgical instrument isconnected if it determines that a subsequent step of the procedurerequires the use of the instrument. Proactively activating the energysource allows the instrument to be ready for use a soon as the precedingstep of the procedure is completed.

As another example, a situationally aware surgical hub 5104 coulddetermine whether the current or subsequent step of the surgicalprocedure requires a different view or degree of magnification on thedisplay according to the feature(s) at the surgical site that thesurgeon is expected to need to view. The surgical hub 5104 could thenproactively change the displayed view (supplied by, e.g., a medicalimaging device for the visualization system 108) accordingly so that thedisplay automatically adjusts throughout the surgical procedure.

As yet another example, a situationally aware surgical hub 5104 coulddetermine which step of the surgical procedure is being performed orwill subsequently be performed and whether particular data orcomparisons between data will be required for that step of the surgicalprocedure. The surgical hub 5104 can be configured to automatically callup data screens based upon the step of the surgical procedure beingperformed, without waiting for the surgeon to ask for the particularinformation.

Another benefit includes checking for errors during the setup of thesurgical procedure or during the course of the surgical procedure. Forexample, a situationally aware surgical hub 5104 could determine whetherthe operating theater is setup properly or optimally for the surgicalprocedure to be performed. The surgical hub 5104 can be configured todetermine the type of surgical procedure being performed, retrieve thecorresponding checklists, product location, or setup needs (e.g., from amemory), and then compare the current operating theater layout to thestandard layout for the type of surgical procedure that the surgical hub5104 determines is being performed. In one exemplification, the surgicalhub 5104 can be configured to compare the list of items for theprocedure (scanned by the scanner 5132 depicted in FIG. 85B, forexample) and/or a list of devices paired with the surgical hub 5104 to arecommended or anticipated manifest of items and/or devices for thegiven surgical procedure. If there are any discontinuities between thelists, the surgical hub 5104 can be configured to provide an alertindicating that a particular modular device 5102, patient monitoringdevice 5124, and/or other surgical item is missing. In oneexemplification, the surgical hub 5104 can be configured to determinethe relative distance or position of the modular devices 5102 andpatient monitoring devices 5124 via proximity sensors, for example. Thesurgical hub 5104 can compare the relative positions of the devices to arecommended or anticipated layout for the particular surgical procedure.If there are any discontinuities between the layouts, the surgical hub5104 can be configured to provide an alert indicating that the currentlayout for the surgical procedure deviates from the recommended layout.

As another example, a situationally aware surgical hub 5104 coulddetermine whether the surgeon (or other medical personnel) was making anerror or otherwise deviating from the expected course of action duringthe course of a surgical procedure. For example, the surgical hub 5104can be configured to determine the type of surgical procedure beingperformed, retrieve the corresponding list of steps or order ofequipment usage (e.g., from a memory), and then compare the steps beingperformed or the equipment being used during the course of the surgicalprocedure to the expected steps or equipment for the type of surgicalprocedure that the surgical hub 5104 determined is being performed. Inone exemplification, the surgical hub 5104 can be configured to providean alert indicating that an unexpected action is being performed or anunexpected device is being utilized at the particular step in thesurgical procedure.

Overall, the situational awareness system for the surgical hub 5104improves surgical procedure outcomes by adjusting the surgicalinstruments (and other modular devices 5102) for the particular contextof each surgical procedure (such as adjusting to different tissue types)and validating actions during a surgical procedure. The situationalawareness system also improves surgeons' efficiency in performingsurgical procedures by automatically suggesting next steps, providingdata, and adjusting displays and other modular devices 5102 in thesurgical theater according to the specific context of the procedure.

FIG. 82A illustrates a logic flow diagram of a process 5000 a forcontrolling a modular device 5102 according to contextual informationderived from received data, in accordance with at least one aspect ofthe present disclosure. In other words, a situationally aware surgicalhub 5104 can execute the process 5000 a to determine appropriate controladjustments for modular devices 5102 paired with the surgical hub 5104before, during, or after a surgical procedure as dictated by the contextof the surgical procedure. In the following description of the process5000 a, reference should also be made to FIG. 81. In oneexemplification, the process 5000 a can be executed by a control circuitof a surgical hub 5104, as depicted in FIG. 10 (processor 244). Inanother exemplification, the process 5000 a can be executed by a cloudcomputing system 104, as depicted in FIG. 1. In yet anotherexemplification, the process 5000 a can be executed by a distributedcomputing system including at least one of the aforementioned cloudcomputing system 104 and/or a control circuit of a surgical hub 5104 incombination with a control circuit of a modular device, such as themicrocontroller 461 of the surgical instrument depicted in FIG. 12, themicrocontroller 620 of the surgical instrument depicted in FIG. 16, thecontrol circuit 710 of the robotic surgical instrument 700 depicted inFIG. 17, the control circuit 760 of the surgical instruments 750, 790depicted in FIGS. 18 and 19, or the controller 838 of the generator 800depicted in FIG. 20. For economy, the following description of theprocess 5000 a will be described as being executed by the controlcircuit of a surgical hub 5104; however, it should be understood thatthe description of the process 5000 a encompasses all of theaforementioned exemplifications.

The control circuit of the surgical hub 5104 executing the process 5000a receives 5004 a data from one or more data sources 5126 to which thesurgical hub 5104 is communicably connected. The data sources 5126include, for example, databases 5122, patient monitoring devices 5124,and modular devices 5102. In one exemplification, the databases 5122 caninclude a patient EMR database associated with the medical facility atwhich the surgical procedure is being performed. The data received 5004a from the data sources 5126 can include perioperative data, whichincludes preoperative data, intraoperative data, and/or postoperativedata associated with the given surgical procedure. The data received5004 a from the databases 5122 can include the type of surgicalprocedure being performed or the patient's medical history (e.g.,medical conditions that may or may not be the subject of the presentsurgical procedure). In one exemplification depicted in FIG. 83A, thecontrol circuit can receive 5004 a the patient or surgical proceduredata by querying the patient EMR database with a unique identifierassociated with the patient. The surgical hub 5104 can receive theunique identifier from, for example, a scanner 5128 for scanning thepatient's wristband 5130 encoding the unique identifier associated withthe patient when the patient enters the operating theater, as depictedin FIG. 85A. In one exemplification, the patient monitoring devices 5124include BP monitors, EKG monitors, and other such devices that areconfigured to monitor one or more parameters associated with a patient.As with the modular devices 5102, the patient monitoring devices 5124can be paired with the surgical hub 5104 such that the surgical hub 5104receives 5004 a data therefrom. In one exemplification, the datareceived 5004 a from the modular devices 5102 that are paired with(i.e., communicably coupled to) the surgical hub 5104 includes, forexample, activation data (i.e., whether the device is powered on or inuse), data of the internal state of the modular device 5102 (e.g., forceto fire or force to close for a surgical cutting and stapling device,pressure differential for an insufflator or smoke evacuator, or energylevel for an RF or ultrasonic surgical instrument), or patient data(e.g., tissue type, tissue thickness, tissue mechanical properties,respiration rate, or airway volume).

As the process 5000 a continues, the control circuit of the surgical hub5104 can derive 5006 a contextual information from the data received5004 a from the data sources 5126. The contextual information caninclude, for example, the type of procedure being performed, theparticular step being performed in the surgical procedure, the patient'sstate (e.g., whether the patient is under anesthesia or whether thepatient is in the operating room), or the type of tissue being operatedon. The control circuit can derive 5006 a contextual informationaccording to data from ether an individual data source 5126 orcombinations of data sources 5126. Further, the control circuit canderive 5006 a contextual information according to, for example, thetype(s) of data that it receives, the order in which the data isreceived, or particular measurements or values associated with the data.For example, if the control circuit receives data from an RF generatorindicating that the RF generator has been activated, the control circuitcould thus infer that the RF electrosurgical instrument is now in useand that the surgeon is or will be performing a step of the surgicalprocedure utilizing the particular instrument. As another example, ifthe control circuit receives data indicating that a laparoscope imagingdevice has been activated and an ultrasonic generator is subsequentlyactivated, the control circuit can infer that the surgeon is on alaparoscopic dissection step of the surgical procedure due to the orderin which the events occurred. As yet another example, if the controlcircuit receives data from a ventilator indicating that the patient'srespiration is below a particular rate, then the control circuit candetermine that the patient is under anesthesia.

The control circuit can then determine 5008 a what control adjustmentsare necessary (if any) for one or more modular devices 5102 according tothe derived 5006 a contextual information. After determining 5008 a thecontrol adjustments, the control circuit of the surgical hub 5104 canthen control 5010 a the modular devices according to the controladjustments (if the control circuit determined 5008 a that any werenecessary). For example, if the control circuit determines that anarthroscopic procedure is being performed and that the next step in theprocedure utilizes an RF or ultrasonic surgical instrument in a liquidenvironment, the control circuit can determine 5008 a that a controladjustment for the generator of the RF or ultrasonic surgical instrumentis necessary to preemptively increase the energy output of theinstrument (because such instruments require increased energy in liquidenvironments to maintain their effectiveness). The control circuit canthen control 5010 a the generator and/or the RF or ultrasonic surgicalinstrument accordingly by causing the generator to increase its outputand/or causing the RF or ultrasonic surgical instrument to increase theenergy drawn from the generator. The control circuit can control 5010 athe modular devices 5102 according to the determined 5008 a controladjustment by, for example, transmitting the control adjustments to theparticular modular device to update the modular device's 5102programming. In another exemplification wherein the modular device(s)5102 and the surgical hub 5104 are executing a distributed computingarchitecture, the control circuit can control 5010 a the modular device5102 according to the determined 5008 a control adjustments by updatingthe distributed program.

FIGS. 82B-D illustrate representative implementations of the process5000 a depicted in FIG. 82A. As with the process 5000 a depicted in FIG.82A, the processes illustrated in FIGS. 82B-D can, in oneexemplification, be executed by a control circuit of the surgical hub5104. FIG. 82B illustrates a logic flow diagram of a process 5000 b forcontrolling a second modular device according to contextual informationderived from perioperative data received from a first modular device, inaccordance with at least one aspect of the present disclosure. In theillustrated exemplification, the control circuit of the surgical hub5104 receives 5004 b perioperative data from a first modular device. Theperioperative data can include, for example, data regarding the modulardevice 5102 itself (e.g., pressure differential, motor current, internalforces, or motor torque) or data regarding the patient with which themodular device 5102 is being utilized (e.g., tissue properties,respiration rate, airway volume, or laparoscopic image data). Afterreceiving 5004 b the perioperative data, the control circuit of thesurgical hub 5104 derives 5006 b contextual information from theperioperative data. The contextual information can include, for example,the procedure type, the step of the procedure being performed, or thestatus of the patient. The control circuit of the surgical hub 5104 thendetermines 5008 b control adjustments for a second modular device basedupon the derived 5006 b contextual information and then controls 5010 bthe second modular device accordingly. For example, the surgical hub5104 can receive 5004 b perioperative data from a ventilator indicatingthat the patient's lung has been deflated, derive 5006 b the contextualinformation therefrom that the subsequent step in the particularprocedure type utilizes a medical imaging device (e.g., a scope),determine 5008 b that the medical imaging device should be activated andset to a particular magnification, and then control 5010 b the medicalimaging device accordingly.

FIG. 82C illustrates a logic flow diagram of a process 5000 c forcontrolling a second modular device according to contextual informationderived from perioperative data received from a first modular device andthe second modular device. In the illustrated exemplification, thecontrol circuit of the surgical hub 5104 receives 5002 c perioperativedata from a first modular device and receives 5004 c perioperative datafrom a second modular device. After receiving 5002 c, 5004 c theperioperative data, the control circuit of the surgical hub 5104 derives5006 c contextual information from the perioperative data. The controlcircuit of the surgical hub 5104 then determines 5008 c controladjustments for the second modular device based upon the derived 5006 ccontextual information and then controls 5010 c the second modulardevice accordingly. For example, the surgical hub 5104 can receive 5002c perioperative data from a RF electrosurgical instrument indicatingthat the instrument has been fired, receive 5004 c perioperative datafrom a surgical stapling instrument indicating that the instrument hasbeen fired, derive 5006 c the contextual information therefrom that thesubsequent step in the particular procedure type requires that thesurgical stapling instrument be fired with a particular force (becausethe optimal force to fire can vary according to the tissue type beingoperated on), determine 5008 c the particular force thresholds thatshould be applied to the surgical stapling instrument, and then control5010 c the surgical stapling instrument accordingly.

FIG. 82D illustrates a logic flow diagram of a process 5000 d forcontrolling a third modular device according to contextual informationderived from perioperative data received from a first modular device anda second modular device. In the illustrated exemplification, the controlcircuit of the surgical hub 5104 receives 5002 d perioperative data froma first modular device and receives 5004 d perioperative data from asecond modular device. After receiving 5002 d, 5004 d the perioperativedata, the control circuit of the surgical hub 5104 derives 5006 dcontextual information from the perioperative data. The control circuitof the surgical hub 5104 then determines 5008 d control adjustments fora third modular device based upon the derived 5006 d contextualinformation and then controls 5010 d the third modular deviceaccordingly. For example, the surgical hub 5104 can receive 5002 d, 5004d perioperative data from an insufflator and a medical imaging deviceindicating that both devices have been activated and paired to thesurgical hub 5104, derive 5006 d the contextual information therefromthat a video-assisted thoracoscopic surgery (VATS) procedure is beingperformed, determine 5008 d that the displays connected to the surgicalhub 5104 should be set to display particular views or informationassociated with the procedure type, and then control 5010 d the displaysaccordingly.

FIG. 83A illustrates a diagram of a surgical system 5100 including asurgical hub 5104 communicably coupled to a particular set of datasources 5126. A surgical hub 5104 including a situational awarenesssystem can utilize the data received from the data sources 5126 toderive contextual information regarding the surgical procedure that thesurgical hub 5104, the modular devices 5102 paired to the surgical hub5104, and the patient monitoring devices 5124 paired to the surgical hub5104 are being utilized in connection with. The inferences (i.e.,contextual information) that one exemplification of the situationalawareness system can derive from the particular set of data sources 5126are depicted in dashed boxes extending from the data source(s) 5126 fromwhich they are derived. The contextual information derived from the datasources 5126 can include, for example, what step of the surgicalprocedure is being performed, whether and how a particular modulardevice 5102 is being used, and the patient's condition.

In the example illustrated in FIG. 83A, the data sources 5126 include adatabase 5122, a variety of modular devices 5102, and a variety ofpatient monitoring devices 5124. The surgical hub 5104 can be connectedto various databases 5122 to retrieve therefrom data regarding thesurgical procedure that is being performed or is to be performed. In oneexemplification of the surgical system 5100, the databases 5122 includean EMR database of a hospital. The data that can be received by thesituational awareness system of the surgical hub 5104 from the databases5122 can include, for example, start (or setup) time or operationalinformation regarding the procedure (e.g., a segmentectomy in the upperright portion of the thoracic cavity). The surgical hub 5104 can derivecontextual information regarding the surgical procedure from this dataalone or from the combination of this data and data from other datasources 5126.

The surgical hub 5104 can also be connected to (i.e., paired with) avariety of patient monitoring devices 5124. In one exemplification ofthe surgical system 5100, the patient monitoring devices 5124 that canbe paired with the surgical hub 5104 can include a pulse oximeter (SpO₂monitor) 5114, a BP monitor 5116, and an EKG monitor 5120. Theperioperative data that can be received by the situational awarenesssystem of the surgical hub 5104 from the patient monitoring devices 5124can include, for example, the patient's oxygen saturation, bloodpressure, heart rate, and other physiological parameters. The contextualinformation that can be derived by the surgical hub 5104 from theperioperative data transmitted by the patient monitoring devices 5124can include, for example, whether the patient is located in theoperating theater or under anesthesia. The surgical hub 5104 can derivethese inferences from data from the patient monitoring devices 5124alone or in combination with data from other data sources 5126 (e.g.,the ventilator 5118).

The surgical hub 5104 can also be connected to (i.e., paired with) avariety of modular devices 5102. In one exemplification of the surgicalsystem 5100, the modular devices 5102 that can be paired with thesurgical hub 5104 can include a smoke evacuator 5106, a medical imagingdevice 5108, an insufflator 5110, a combined energy generator 5112 (forpowering an ultrasonic surgical instrument and/or an RF electrosurgicalinstrument), and a ventilator 5118.

The medical imaging device 5108 includes an optical component and animage sensor that generates image data. The optical component includes alens or a light source, for example. The image sensor includes acharge-coupled device (CCD) or a complementary metal-oxide-semiconductor(CMOS), for example. In various exemplifications, the medical imagingdevice 5108 includes an endoscope, a laparoscope, a thoracoscope, andother such imaging devices. Various additional components of the medicalimaging device 5108 are described above. The perioperative data that canbe received by the surgical hub 5104 from the medical imaging device5108 can include, for example, whether the medical imaging device 5108is activated and a video or image feed. The contextual information thatcan be derived by the surgical hub 5104 from the perioperative datatransmitted by the medical imaging device 5108 can include, for example,whether the procedure is a VATS procedure (based on whether the medicalimaging device 5108 is activated or paired to the surgical hub 5104 atthe beginning or during the course of the procedure). Furthermore, theimage or video data from the medical imaging device 5108 (or the datastream representing the video for a digital medical imaging device 5108)can processed by a pattern recognition system or a machine learningsystem to recognize features (e.g., organs or tissue types) in the fieldof view (FOV) of the medical imaging device 5108, for example. Thecontextual information that can be derived by the surgical hub 5104 fromthe recognized features can include, for example, what type of surgicalprocedure (or step thereof) is being performed, what organ is beingoperated on, or what body cavity is being operated in.

In one exemplification depicted in FIG. 83B, the smoke evacuator 5106includes a first pressure sensor P₁ configured to detect the ambientpressure in the operating theater, a second pressure sensor P₂configured to detect the internal downstream pressure (i.e., thepressure downstream from the inlet), and a third pressure sensor P₃configured to detect the internal upstream pressure. In oneexemplification, the first pressure sensor P₁ can be a separatecomponent from the smoke evacuator 5106 or otherwise located externallyto the smoke evacuator 5106. The perioperative data that can be receivedby the surgical hub 5104 from the smoke evacuator 5106 can include, forexample, whether the smoke evacuator 5106 is activated, pressurereadings from each of the sensors P₁, P₂, P₃, and pressure differentialsbetween pairs of the sensors P₁, P₂, P₃. The perioperative data can alsoinclude, for example, the type of tissue being operated on (based uponthe chemical composition of the smoke being evacuated) and the amount oftissue being cut. The contextual information that can be derived by thesurgical hub 5104 from the perioperative data transmitted by the smokeevacuator 5106 can include, for example, whether the procedure beingperformed is utilizing insufflation. The smoke evacuator 5106perioperative data can indicate whether the procedure is utilizinginsufflation according to the pressure differential between P₃ and P₁.If the pressure sensed by P₃ is greater than the pressure sensed by P₁(i.e., P₃−P₁>0), then the body cavity to which the smoke evacuator 5106is connected is insufflated. If the pressure sensed by P₃ is equal tothe pressure sensed by P₁ (i.e., P₃−P₁=0), then the body cavity is notinsufflated. When the body cavity is not insufflated, the procedure maybe an open type of procedure.

The insufflator 5110 can include, for example, pressure sensors andcurrent sensors configured to detect internal parameters of theinsufflator 5110. The perioperative data that can be received by thesurgical hub 5104 from the insufflator can include, for example, whetherthe insufflator 5110 is activated and the electrical current drawn bythe insufflator's 5110 pump. The surgical hub 5104 can determine whetherthe insufflator 5110 is activated by, for example, directly detectingwhether the device is powered on, detecting whether there is a pressuredifferential between an ambient pressure sensor and a pressure sensorinternal to the surgical site, or detecting whether the pressure valvesof the insufflator 5110 are pressurized (activated) or non-pressurized(deactivated). The contextual information that can be derived by thesurgical hub 5104 from the perioperative data transmitted by theinsufflator 5110 can include, for example, the type of procedure beingperformed (e.g., insufflation is utilized in laparoscopic procedures,but not arthroscopic procedures) and what body cavity is being operatedin (e.g., insufflation is utilized in the abdominal cavity, but not inthe thoracic cavity). In some exemplifications, the inferences derivedfrom the perioperative data received from different modular devices 5102can be utilized to confirm and/or increase the confidence of priorinferences. For example, if the surgical hub 5104 determines that theprocedure is utilizing insufflation because the insufflator 5110 isactivated, the surgical hub 5104 can then confirm that inference bydetecting whether the perioperative data from the smoke evacuator 5106likewise indicates that the body cavity is insufflated.

The combined energy generator 5112 supplies energy to one or moreultrasonic surgical instruments or RF electrosurgical instrumentsconnected thereto. The perioperative data that can be received by thesurgical hub 5104 from the combined energy generator 5112 can include,for example, the mode that the combined energy generator 5112 is set to(e.g., a vessel sealing mode or a cutting/coagulation mode). Thecontextual information that can be derived by the surgical hub 5104 fromthe perioperative data transmitted by the combined energy generator 5112can include, for example, the surgical procedural type (based on thenumber and types of surgical instruments that are connected to theenergy generator 5112) and the procedural step that is being performed(because the particular surgical instrument being utilized or theparticular order in which the surgical instruments are utilizedcorresponds to different steps of the surgical procedure). Further, theinferences derived by the surgical hub 5104 can depend upon inferencesand/or perioperative data previously received by the surgical hub 5104.Once the surgical hub 5104 has determined the general category orspecific type of surgical procedure being performed, the surgical hub5104 can determine or retrieve an expected sequence of steps for thesurgical procedure and then track the surgeon's progression through thesurgical procedure by comparing the detected sequence in which thesurgical instruments are utilized relative to the expected sequence.

The perioperative data that can be received by the surgical hub 5104from the ventilator 5118 can include, for example, the respiration rateand airway volume of the patient. The contextual information that can bederived by the surgical hub 5104 from the perioperative data transmittedby the ventilator 5118 can include, for example, whether the patient isunder anesthesia and whether the patient's lung is deflated. In someexemplifications, certain contextual information can be inferred by thesurgical hub 5104 based on combinations of perioperative data frommultiple data sources 5126. For example, the situational awarenesssystem of the surgical hub 5104 can be configured to infer that thepatient is under anesthesia when the respiration rate detected by theventilator 5118, the blood pressure detected by the BP monitor 5116, andthe heart rate detected by the EKG monitor 5120 fall below particularthresholds. For certain contextual information, the surgical hub 5104can be configured to only derive a particular inference when theperioperative data from a certain number or all of the relevant datasources 5126 satisfy the conditions for the inference.

As can be seen from the particular exemplified surgical system 5100, thesituational awareness system of a surgical hub 5104 can derive a varietyof contextual information regarding the surgical procedure beingperformed from the data sources 5126. The surgical hub 5104 can utilizethe derived contextual information to control the modular devices 5102and make further inferences about the surgical procedure in combinationwith data from other data sources 5126. It should be noted that theinferences depicted in FIG. 83A and described in connection with thedepicted surgical system 5100 are merely exemplary and should not beinterpreted as limiting in any way. Furthermore, the surgical hub 5104can be configured to derive a variety of other inferences from the same(or different) modular devices 5102 and/or patient monitoring devices5124. In other exemplifications, a variety of other modular devices 5102and/or patient monitoring devices 5124 can be paired to the surgical hub5104 in the operating theater and data received from those additionalmodular devices 5102 and/or patient monitoring devices 5124 can beutilized by the surgical hub 5104 to derive the same or differentcontextual information about the particular surgical procedure beingperformed.

FIGS. 84A-J depict logic flow diagrams for processes for deriving 5008a, 5008 b, 5008 c, 5008 d contextual information from various modulardevices, as discussed above with respect to the processes 5000 a, 5000b, 5000 c, 5000 d depicted in FIGS. 82A-D. The derived contextualinformation in FIGS. 84A-C is the procedure type. The procedure type cancorrespond to techniques utilized during the surgical procedure (e.g., asegmentectomy), the category of the surgical procedure (e.g., alaparoscopic procedure), the organ, tissue, or other structure beingoperated on, and other characteristics to identify the particularsurgical procedure (e.g., the procedure utilizes insufflation). Thederived contextual information in FIGS. 84D-G is the particular step ofthe surgical procedure that is being performed. The derived contextualinformation in FIGS. 84H-J is the patient's status. It can be noted thatthe patient's status can also correspond to the particular step of thesurgical procedure that is being performed (e.g., determining that thepatient's status has changed from not being under anesthesia to beingunder anesthesia can indicate that the step of the surgical procedure ofplacing the patient under anesthesia was carried out by the surgicalstaff). As with the process 5000 a depicted in FIG. 82A, the processesillustrated in FIGS. 84A-J can, in one exemplification, be executed by acontrol circuit of the surgical hub 5104. In the following descriptionsof the processes illustrated in FIGS. 84A-J, reference should also bemade to FIG. 83A.

FIG. 84A illustrates a logic flow diagram of a process 5111 fordetermining a procedure type according to smoke evacuator 5106perioperative data. In this exemplification, the control circuit of thesurgical hub 5104 executing the process 5111 receives 5113 perioperativedata from the smoke evacuator 5106 and then determines 5115 whether thesmoke evacuator 5106 is activated based thereon. If the smoke evacuator5106 is not activated, then the process 5111 continues along the NObranch and the control circuit of the surgical hub 5104 continuesmonitoring for the receipt of smoke evacuator 5106 perioperative data.If the smoke evacuator 5106 is activated, then the process 5111continues along the YES branch and the control circuit of the surgicalhub 5104 determines 5117 whether there is a pressure differentialbetween an internal upstream pressure sensor P₃ (FIG. 83B) and anexternal or ambient pressure sensor P₁ (FIG. 83B). If there is apressure differential (i.e., the internal upstream pressure of the smokeevacuator 5106 is greater then the ambient pressure of the operatingtheater), then the process 5111 continues along the YES branch and thecontrol circuit determines 5119 that the surgical procedure is aninsufflation-utilizing procedure. If there is not a pressuredifferential, then the process 5111 continues along the NO branch andthe control circuit determines 5121 that the surgical procedure is notan insufflation-utilizing procedure.

FIG. 84B illustrates a logic flow diagram of a process 5123 fordetermining a procedure type according to smoke evacuator 5106,insufflator 5110, and medical imaging device 5108 perioperative data. Inthis exemplification, the control circuit of the surgical hub 5104executing the process 5123 receives 5125, 5127, 5129 perioperative datafrom the smoke evacuator 5106, insufflator 5110, and medical imagingdevice 5108 and then determines 5131 whether all of the devices areactivated or paired with the surgical hub 5104. If all of these devicesare not activated or paired with the surgical hub 5104, then the process5123 continues along the NO branch and the control circuit determines5133 that the surgical procedure is not a VATS procedure. If all of theaforementioned devices are activated or paired with the surgical hub5104, then the process 5123 continues along the YES branch and thecontrol circuit determines 5135 that the surgical procedure is a VATSprocedure. The control circuit can make this determination based uponthe fact that al of these devices are required for a VATS procedure;therefore, if not all of these devices are being utilized in thesurgical procedure, it cannot be a VATS procedure.

FIG. 84C illustrates a logic flow diagram of a process 5137 fordetermining a procedure type according to medical imaging device 5108perioperative data. In this exemplification, the control circuit of thesurgical hub 5104 executing the process 5137 receives 5139 perioperativedata from the medical imaging device 5108 and then determines 5141whether the medical imaging device 5108 is transmitting an image orvideo feed. If the medical imaging device 5108 is not transmitting animage or video feed, then the process 5137 continues along the NO branchand the control circuit determines 5143 that the surgical procedure isnot a VATS procedure. If the medical imaging device 5108 is nottransmitting an image or video feed, then the process 5137 continuesalong the YES branch and the control circuit determines 5145 that thesurgical procedure is a VATS procedure. In one exemplification, thecontrol circuit of the surgical hub 5104 can execute the process 5137depicted in FIG. 84C in combination with the process 5123 depicted inFIG. 84B in order to confirm or increase the confidence in thecontextual information derived by both processes 5123, 5137. If there isa discontinuity between the determinations of the processes 5123, 5137(e.g., the medical imaging device 5108 is transmitting a feed, but notall of the requisite devices are paired with the surgical hub 5104),then the surgical hub 5104 can execute additional processes to come to afinal determination that resolves the discontinuities between theprocesses 5123, 5137 or display an alert or feedback to the surgicalstaff as to the discontinuity.

FIG. 84D illustrates a logic flow diagram of a process 5147 fordetermining a procedural step according to insufflator 5110perioperative data. In this exemplification, the control circuit of thesurgical hub 5104 executing the process 5147 receives 5149 perioperativedata from the insufflator 5110 and then determines 5151 whether there isa pressure differential between the surgical site and the ambientenvironment of the operating theater. In one exemplification, theinsufflator 5110 perioperative data can include a surgical site pressure(e.g., the intra-abdominal pressure) sensed by a first pressure sensorassociated with the insufflator 5110, which can be compared against apressure sensed by a second pressure sensor configured to detect theambient pressure. The first pressure sensor can be configured to detectan intra-abdominal pressure between 0-10 mmHg, for example. If there isa pressure differential, then the process 5147 continues along the YESbranch and the control circuit determines 5153 that aninsufflation-utilizing step of the surgical procedure is beingperformed. If there is not a pressure differential, then the process5147 continues along the NO branch and the control circuit determines5155 that an insufflation-utilizing step of the surgical procedure isnot being performed.

FIG. 84E illustrates a logic flow diagram of a process 5157 fordetermining a procedural step according to energy generator 5112perioperative data. In this exemplification, the control circuit of thesurgical hub 5104 executing the process 5157 receives 5159 perioperativedata from the energy generator 5112 and then determines 5161 whether theenergy generator 5112 is in the sealing mode. In variousexemplifications, the energy generator 5112 can include two modes: asealing mode corresponding to a first energy level and a cut/coagulationmode corresponding to a second energy level. If the energy generator5112 is not in the sealing mode, then the process 5157 proceeds alongthe NO branch and the control circuit determines 5163 that a dissectionstep of the surgical procedure is being performed. The control circuitcan make this determination 5163 because if the energy generator 5112 isnot on the sealing mode, then it must thus be on the cut/coagulationmode for energy generators 5112 having two modes of operation. Thecut/coagulation mode of the energy generator 5112 corresponds to adissection procedural step because it provides an appropriate degree ofenergy to the ultrasonic surgical instrument or RF electrosurgicalinstrument to dissect tissue. If the energy generator 5112 is in thesealing mode, then the process 5157 proceeds along the YES branch andthe control circuit determines 5165 that a ligation step of the surgicalprocedure is being performed. The sealing mode of the energy generator5112 corresponds to a ligation procedural step because it provides anappropriate degree of energy to the ultrasonic surgical instrument or RFelectrosurgical instrument to ligate vessels.

FIG. 84F illustrates a logic flow diagram of a process 5167 fordetermining a procedural step according to energy generator 5112perioperative data. In various aspects, previously receivedperioperative data and/or previously derived contextual information canalso be considered by processes in deriving subsequent contextualinformation. This allows the situational awareness system of thesurgical hub 5104 to derive additional and/or increasingly detailedcontextual information about the surgical procedure as the procedure isperformed. In this exemplification, the process 5167 determines 5169that a segmentectomy procedure is being performed. This contextualinformation can be derived by this process 5167 or other processes basedupon other received perioperative data and/or retrieved from a memory.Subsequently, the control circuit receives 5171 perioperative data fromthe energy generator 5112 indicating that a surgical instrument is beingfired and then determines 5173 whether the energy generator 5112 wasutilized in a previous step of the procedure to fire the surgicalinstrument. The control circuit can determine 5173 whether the energygenerator 5112 was previously utilized in a prior step of the procedureby retrieving a list of the steps that have been performed in thecurrent surgical procedure from a memory, for example. In suchexemplifications, when the surgical hub 5104 determines that a step ofthe surgical procedure has been performed or completed by the surgicalstaff, the surgical hub 5104 can update a list of the procedural stepsthat have been performed, which can then be subsequently retrieved bythe control circuit of the surgical hub 5104. In one exemplification,the surgical hub 5104 can distinguish between sequences of firings ofthe surgical instrument as corresponding to separate steps of thesurgical procedure according to the time delay between the sequences offirings, whether any intervening actions were taken or modular devices5102 were utilized by the surgical staff, or other factors that thesituational awareness system can detect. If the energy generator 5112has not been previously utilized during the course of the segmentectomyprocedure, the process 5167 proceeds along the NO branch and the controlcircuit determines 5175 that the step of dissecting tissue to mobilizethe patient's lungs is being performed by the surgical staff. If theenergy generator 5112 has been previously utilized during the course ofthe segmentectomy procedure, the process 5167 proceeds along the YESbranch and the control circuit determines 5177 that the step ofdissecting nodes is being performed by the surgical staff. An ultrasonicsurgical instrument or RF electrosurgical instrument is utilized twiceduring the course of an example of a segmentectomy procedure (e.g., FIG.86); therefore, the situational awareness system of the surgical hub5104 executing the process 5167 can distinguish between which step theutilization of the energy generator 5112 indicates is currently beingperformed based upon whether the energy generator 5112 was previouslyutilized.

FIG. 84G illustrates a logic flow diagram of a process 5179 fordetermining a procedural step according to stapler perioperative data.As described above with respect to the process 5167 illustrated in FIG.84F, the process 5179 utilizes previously received perioperative dataand/or previously derived contextual information in deriving subsequentcontextual information. In this exemplification, the process 5179determines 5181 that a segmentectomy procedure is being performed. Thiscontextual information can be derived by this process 5179 or otherprocesses based upon other received perioperative data and/or retrievedfrom a memory. Subsequently, the control circuit receives 5183perioperative data from the surgical stapling instrument (i.e., stapler)indicating that the surgical stapling instrument is being fired and thendetermines 5185 whether the surgical stapling instrument was utilized ina previous step of the surgical procedure. As described above, thecontrol circuit can determine 5185 whether the surgical staplinginstrument was previously utilized in a prior step of the procedure byretrieving a list of the steps that have been performed in the currentsurgical procedure from a memory, for example. If the surgical staplinginstrument has not been utilized previously, then the process 5179proceeds along the NO branch and the control circuit determines 5187that the step of ligating arteries and veins is being performed by thesurgical staff. If the surgical stapling instrument has been previouslyutilized during the course of the segmentectomy procedure, the process5179 proceeds along the YES branch and the control circuit determines5189 that the step of transecting parenchyma is being performed by thesurgical staff. A surgical stapling instrument is utilized twice duringthe course of an example of a segmentectomy procedure (e.g., FIG. 86);therefore, the situational awareness system of the surgical hub 5104executing the process 5179 can distinguish between which step theutilization of the surgical stapling instrument indicates is currentlybeing performed based upon whether the surgical stapling instrument waspreviously utilized.

FIG. 84H illustrates a logic flow diagram of a process 5191 fordetermining a patient status according to ventilator 5110, pulseoximeter 5114, BP monitor 5116, and/or EKG monitor 5120 perioperativedata. In this exemplification, the control circuit of the surgical hub5104 executing the process 5191 receives 5193, 5195, 5197, 5199perioperative data from each of the ventilator 5110, pulse oximeter5114, BP monitor 5116, and/or EKG monitor 5120 and then determineswhether one or more values of the physiological parameters sensed byeach of the devices fall below a threshold for each of the physiologicalparameters. The threshold for each physiological parameter cancorrespond to a value that corresponds to a patient being underanesthesia. In other words, the control circuit determines 5201 whetherthe patient's respiration rate, oxygen saturation, blood pressure,and/or heart rate indicate that the patient is under anesthesiaaccording data sensed by the respective modular device 5102 and/orpatient monitoring devices 5124. In one exemplification, if the all ofthe values from the perioperative data are below their respectivethresholds, then the process 5191 proceeds along the YES branch and thecontrol circuit determines 5203 that the patient is under anesthesia. Inanother exemplification, the control circuit can determine 5203 that thepatient is under anesthesia if a particular number or ratio of themonitored physiological parameters indicate that the patient is underanesthesia. Otherwise, the process 5191 proceeds along the NO branch andthe control circuit determines 5205 that the patient is not underanesthesia.

FIG. 84I illustrates a logic flow diagram of a process 5207 fordetermining a patient status according to pulse oximeter 5114, BPmonitor 5116, and/or EKG monitor 5120 perioperative data. In thisexemplification, the control circuit of the surgical hub 5104 executingthe process 5207 receives 5209, 5211, 5213 (or attempts to receive)perioperative data the pulse oximeter 5114, BP monitor 5116, and/or EKGmonitor 5120 and then determines 5215 whether at least one of thedevices is paired with the surgical hub 5104 or the surgical hub 5104 isotherwise receiving data therefrom. If the control circuit is receivingdata from at least one of these patient monitoring devices 5124, theprocess 5207 proceeds along the YES branch and the control circuitdetermines 5217 that the patient is in the operating theater. Thecontrol circuit can make this determination because the patientmonitoring devices 5214 connected to the surgical hub 5104 must be inthe operating theater and thus the patient must likewise be in theoperating theater. If the control circuit is not receiving data from atleast one of these patient monitoring devices 5124, the process 5207proceeds along the NO branch and the control circuit determines 5219that the patient is not in the operating theater.

FIG. 84J illustrates a logic flow diagram of a process 5221 fordetermining a patient status according to ventilator 5110 perioperativedata. In this exemplification, the control circuit of the surgical hub5104 executing the process 5221 receives 5223 perioperative data fromthe ventilator 5110 and then determines 5225 whether the patient'sairway volume has decreased or is decreasing. In one exemplification,the control circuit determines 5225 whether the patient's airway volumefalls below a particular threshold value indicative of a lung havingcollapsed or been deflated. In another exemplification, the controlcircuit determines 5225 whether the patient's airway volume falls belowan average or baseline level by a threshold amount. If the patient'sairway volume has not decreased sufficiently, the process 5221 proceedsalong the NO branch and the control circuit determines 5227 that thepatient's lung is not deflated. If the patient's airway volume hasdecreased sufficiently, the process 5221 proceeds along the YES branchand the control circuit determines 5229 that the patient's lung is notdeflated.

In one exemplification, the surgical system 5100 can further includevarious scanners that can be paired with the surgical hub 5104 to detectand record objects and individuals that enter and exit the operatingtheater. FIG. 85A illustrates a scanner 5128 paired with a surgical hub5104 that is configured to scan a patient wristband 5130. In one aspect,the scanner 5128 includes, for example, a barcode reader or aradio-frequency identification (RFID) reader that is able to readpatient information from the patient wristband 5130 and then transmitthat information to the surgical hub 5104. The patient information caninclude the surgical procedure to be performed or identifyinginformation that can be cross-referenced with the hospital's EMRdatabase 5122 by the surgical hub 5104, for example. FIG. 85Billustrates a scanner 5132 paired with a surgical hub 5104 that isconfigured to scan a product list 5134 for a surgical procedure. Thesurgical hub 5104 can utilize data from the scanner 5132 regarding thenumber, type, and mix of items to be used in the surgical procedure toidentify the type of surgical procedure being performed. In oneexemplification, the scanner 5132 includes a product scanner (e.g., abarcode reader or an RFID reader) that is able to read the productinformation (e.g., name and quantity) from the product itself or theproduct packaging as the products are brought into the operating theaterand then transmit that information to the surgical hub 5104. In anotherexemplification, the scanner 5132 includes a camera (or othervisualization device) and associated optical character recognitionsoftware that is able to read the product information from a productlist 5134. The surgical hub 5104 can be configured to cross-referencethe list of items indicated by the received data with a lookup table ordatabase of items utilized for various types of surgical procedures inorder to infer the particular surgical procedure that is to be (or was)performed. As shown in FIG. 85B, the illustrative product list 5134includes ring forceps, rib spreaders, a powered vascular stapler (PVS),and a thoracic wound protector. In this example, the surgical hub 5104can infer that the surgical procedure is a thoracic procedure from thisdata since these products are only utilized in thoracic procedures. Insum, the scanner(s) 5128, 5132 can provide serial numbers, productlists, and patient information to the surgical hub 5104. Based on thisdata regarding what devices and instruments are being utilized and thepatient's medical information, the surgical hub 5104 can determineadditional contextual information regarding the surgical procedure.

In order to assist in the understanding of the process 5000 aillustrated in FIG. 82A and the other concepts discussed above, FIG. 86illustrates a timeline 5200 of an illustrative surgical procedure andthe contextual information that a surgical hub 5104 can derive from thedata received from the data sources 5126 at each step in the surgicalprocedure. In the following description of the timeline 5200 illustratedin FIG. 86, reference should also be made to FIG. 81. The timeline 5200depicts the typical steps that would be taken by the nurses, surgeons,and other medical personnel during the course of a lung segmentectomyprocedure, beginning with setting up the operating theater and endingwith transferring the patient to a post-operative recovery room. Thesituationally aware surgical hub 5104 receives data from the datasources 5126 throughout the course of the surgical procedure, includingdata generated each time medical personnel utilize a modular device 5102that is paired with the surgical hub 5104. The surgical hub 5104 canreceive this data from the paired modular devices 5102 and other datasources 5126 and continually derive inferences (i.e., contextualinformation) about the ongoing procedure as new data is received, suchas which step of the procedure is being performed at any given time. Thesituational awareness system of the surgical hub 5104 is able to, forexample, record data pertaining to the procedure for generating reports(e.g., see FIGS. 90-101), verify the steps being taken by the medicalpersonnel, provide data or prompts (e.g., via a display screen) that maybe pertinent for the particular procedural step, adjust modular devices5102 based on the context (e.g., activate monitors, adjust the FOV ofthe medical imaging device, or change the energy level of an ultrasonicsurgical instrument or RF electrosurgical instrument), and take anyother such action described above.

As the first step 5202 in this illustrative procedure, the hospitalstaff members retrieve the patient's EMR from the hospital's EMRdatabase. Based on select patient data in the EMR, the surgical hub 5104determines that the procedure to be performed is a thoracic procedure.Second 5204, the staff members scan the incoming medical supplies forthe procedure. The surgical hub 5104 cross-references the scannedsupplies with a list of supplies that are utilized in various types ofprocedures and confirms that the mix of supplies corresponds to athoracic procedure (e.g., as depicted in FIG. 85B). Further, thesurgical hub 5104 is also able to determine that the procedure is not awedge procedure (because the incoming supplies either lack certainsupplies that are necessary for a thoracic wedge procedure or do nototherwise correspond to a thoracic wedge procedure). Third 5206, themedical personnel scan the patient band (e.g., as depicted in FIG. 85A)via a scanner 5128 that is communicably connected to the surgical hub5104. The surgical hub 5104 can then confirm the patient's identitybased on the scanned data. Fourth 5208, the medical staff turns on theauxiliary equipment. The auxiliary equipment being utilized can varyaccording to the type of surgical procedure and the techniques to beused by the surgeon, but in this illustrative case they include a smokeevacuator, insufflator, and medical imaging device. When activated, theauxiliary equipment that are modular devices 5102 can automatically pairwith the surgical hub 5104 that is located within a particular vicinityof the modular devices 5102 as part of their initialization process. Thesurgical hub 5104 can then derive contextual information about thesurgical procedure by detecting the types of modular devices 5102 thatpair with it during this pre-operative or initialization phase. In thisparticular example, the surgical hub 5104 determines that the surgicalprocedure is a VATS procedure based on this particular combination ofpaired modular devices 5102. Based on the combination of the data fromthe patient's EMR, the list of medical supplies to be used in theprocedure, and the type of modular devices 5102 that connect to the hub,the surgical hub 5104 can generally infer the specific procedure thatthe surgical team will be performing. Once the surgical hub 5104 knowswhat specific procedure is being performed, the surgical hub 5104 canthen retrieve the steps of that procedure from a memory or from thecloud and then cross-reference the data it subsequently receives fromthe connected data sources 5126 (e.g., modular devices 5102 and patientmonitoring devices 5124) to infer what step of the surgical procedurethe surgical team is performing. Fifth 5210, the staff members attachthe EKG electrodes and other patient monitoring devices 5124 to thepatient. The EKG electrodes and other patient monitoring devices 5124are able to pair with the surgical hub 5104. As the surgical hub 5104begins receiving data from the patient monitoring devices 5124, thesurgical hub 5104 thus confirms that the patient is in the operatingtheater, as described in the process 5207 depicted in FIG. 84I, forexample. Sixth 5212, the medical personnel induce anesthesia in thepatient. The surgical hub 5104 can infer that the patient is underanesthesia based on data from the modular devices 5102 and/or patientmonitoring devices 5124, including EKG data, blood pressure data,ventilator data, or combinations thereof, as described in the process5191 depicted in FIG. 84H, for example. Upon completion of the sixthstep 5212, the pre-operative portion of the lung segmentectomy procedureis completed and the operative portion begins.

Seventh 5214, the patient's lung that is being operated on is collapsed(while ventilation is switched to the contralateral lung). The surgicalhub 5104 can infer from the ventilator data that the patient's lung hasbeen collapsed, as described in the process 5221 depicted in FIG. 84J,for example. The surgical hub 5104 can infer that the operative portionof the procedure has commenced as it can compare the detection of thepatient's lung collapsing to the expected steps of the procedure (whichcan be accessed or retrieved previously) and thereby determine thatcollapsing the lung is the first operative step in this particularprocedure. Eighth 5216, the medical imaging device 5108 (e.g., a scope)is inserted and video from the medical imaging device is initiated. Thesurgical hub 5104 receives the medical imaging device data (i.e., videoor image data) through its connection to the medical imaging device.Upon receipt of the medical imaging device data, the surgical hub 5104can determine that the laparoscopic portion of the surgical procedurehas commenced. Further, the surgical hub 5104 can determine that theparticular procedure being performed is a segmentectomy, as opposed to alobectomy (note that a wedge procedure has already been discounted bythe surgical hub 5104 based on data received at the second step 5204 ofthe procedure). The data from the medical imaging device 124 (FIG. 2)can be utilized to determine contextual information regarding the typeof procedure being performed in a number of different ways, including bydetermining the angle at which the medical imaging device is orientedwith respect to the visualization of the patient's anatomy, monitoringthe number or medical imaging devices being utilized (i.e., that areactivated and paired with the surgical hub 5104), and monitoring thetypes of visualization devices utilized. For example, one technique forperforming a VATS lobectomy places the camera in the lower anteriorcorner of the patient's chest cavity above the diaphragm, whereas onetechnique for performing a VATS segmentectomy places the camera in ananterior intercostal position relative to the segmental fissure. Usingpattern recognition or machine learning techniques, for example, thesituational awareness system can be trained to recognize the positioningof the medical imaging device according to the visualization of thepatient's anatomy. As another example, one technique for performing aVATS lobectomy utilizes a single medical imaging device, whereas anothertechnique for performing a VATS segmentectomy utilizes multiple cameras.As yet another example, one technique for performing a VATSsegmentectomy utilizes an infrared light source (which can becommunicably coupled to the surgical hub as part of the visualizationsystem) to visualize the segmental fissure, which is not utilized in aVATS lobectomy. By tracking any or all of this data from the medicalimaging device 5108, the surgical hub 5104 can thereby determine thespecific type of surgical procedure being performed and/or the techniquebeing used for a particular type of surgical procedure.

Ninth 5218, the surgical team begins the dissection step of theprocedure. The surgical hub 5104 can infer that the surgeon is in theprocess of dissecting to mobilize the patient's lung because it receivesdata from the RF or ultrasonic generator indicating that an energyinstrument is being fired. The surgical hub 5104 can cross-reference thereceived data with the retrieved steps of the surgical procedure todetermine that an energy instrument being fired at this point in theprocess (i.e., after the completion of the previously discussed steps ofthe procedure) corresponds to the dissection step. Tenth 5220, thesurgical team proceeds to the ligation step of the procedure. Thesurgical hub 5104 can infer that the surgeon is ligating arteries andveins because it receives data from the surgical stapling and cuttinginstrument indicating that the instrument is being fired. Similarly tothe prior step, the surgical hub 5104 can derive this inference bycross-referencing the receipt of data from the surgical stapling andcutting instrument with the retrieved steps in the process. Eleventh5222, the segmentectomy portion of the procedure is performed. Thesurgical hub 5104 can infer that the surgeon is transecting theparenchyma based on data from the surgical stapling and cuttinginstrument, including data from its cartridge. The cartridge data cancorrespond to the size or type of staple being fired by the instrument,for example. As different types of staples are utilized for differenttypes of tissues, the cartridge data can thus indicate the type oftissue being stapled and/or transected. In this case, the type of staplebeing fired is utilized for parenchyma (or other similar tissue types),which allows the surgical hub 5104 to infer that the segmentectomyportion of the procedure is being performed. Twelfth 5224, the nodedissection step is then performed. The surgical hub 5104 can infer thatthe surgical team is dissecting the node and performing a leak testbased on data received from the generator indicating that an RF orultrasonic instrument is being fired. For this particular procedure, anRF or ultrasonic instrument being utilized after parenchyma wastransected corresponds to the node dissection step, which allows thesurgical hub 5104 to make this inference. It should be noted thatsurgeons regularly switch back and forth between surgicalstapling/cutting instruments and surgical energy (i.e., RF orultrasonic) instruments depending upon the particular step in theprocedure because different instruments are better adapted forparticular tasks. Therefore, the particular sequence in which thestapling/cutting instruments and surgical energy instruments are usedcan indicate what step of the procedure the surgeon is performing. Uponcompletion of the twelfth step 5224, the incisions and closed up and thepost-operative portion of the procedure begins.

Thirteenth 5226, the patient's anesthesia is reversed. The surgical hub5104 can infer that the patient is emerging from the anesthesia based onthe ventilator data (i.e., the patient's breathing rate beginsincreasing), for example. Lastly, the fourteenth step 5228 is that themedical personnel remove the various patient monitoring devices 5124from the patient. The surgical hub 5104 can thus infer that the patientis being transferred to a recovery room when the hub loses EKG, BP, andother data from the patient monitoring devices 5124. As can be seen fromthe description of this illustrative procedure, the surgical hub 5104can determine or infer when each step of a given surgical procedure istaking place according to data received from the various data sources5126 that are communicably coupled to the surgical hub 5104.

In addition to utilizing the patient data from EMR database(s) to inferthe type of surgical procedure that is to be performed, as illustratedin the first step 5202 of the timeline 5200 depicted in FIG. 86, thepatient data can also be utilized by a situationally aware surgical hub5104 to generate control adjustments for the paired modular devices5102. FIG. 87A illustrates a flow diagram depicting the process 5240 ofimporting patient data stored in an EMR database 5250 and derivinginferences 5256 therefrom, in accordance with at least one aspect of thepresent disclosure. Further, FIG. 87B illustrates a flow diagramdepicting the process 5242 of determining control adjustments 5264corresponding to the derived inferences 5256 from FIG. 87A, inaccordance with at least one aspect of the present disclosure. In thefollowing description of the processes 5240, 5242, reference should alsobe made to FIG. 81.

As shown in FIG. 87A, the surgical hub 5104 retrieves the patientinformation (e.g., EMR) stored in a database 5250 to which the surgicalhub 5104 is communicably connected. The unredacted portion of thepatient data is removed 5252 from the surgical hub 5104, leavinganonymized, stripped patient data 5254 related to the patient'scondition and/or the surgical procedure to be performed. The unredactedpatient data is removed 5252 in order to maintain patient anonymity forthe processing of the data (including if the data is uploaded to thecloud for processing and/or data tracking for reports). The strippedpatient data 5254 can include any medical conditions that the patient issuffering from, the patient's medical history (including previoustreatments or procedures), medication that the patient is taking, andother such medically relevant details. The control circuit of thesurgical hub 5104 can then derive various inferences 5256 from thestripped patient data 5254, which can in turn be utilized by thesurgical hub 5104 to derive various control adjustments for the pairedmodular devices 5102. The derived inferences 5256 can be based uponindividual pieces of data or combinations of pieces of data. Further,the derived inferences 5256 may, in some cases, be redundant with eachother as some data may lead to the same inference. By integrating eachpatient's stripped patient data 5254 into the situational awarenesssystem, the surgical hub 5104 is thus able to generate pre-procedureadjustments to optimally control each of the modular devices 5102 basedon the unique circumstances associated with each individual patient. Inthe illustrated example, the stripped patient data 5254 includes that(i) the patient is suffering from emphysema, (ii) has high bloodpressure, (iii) is suffering from a small cell lung cancer, (iv) istaking warfarin (or another blood thinner), and/or (v) has receivedradiation pretreatment. In the illustrated example, the inferences 5256derived from the stripped patient data 5254 include that (i) the lungtissue will be more fragile than normal lung tissue, (ii) hemostasisissues are more likely, (iii) the patient is suffering from a relativelyaggressive cancer, (iv) hemostasis issues are more likely, and (v) thelung tissue will be stiffer and more prone to fracture, respectively.

After the control circuit of the surgical hub 5104 receives oridentifies the implications 5256 that are derived from anonymizedpatient data, the control circuit of the surgical hub 5104 is configuredto execute a process 5242 to control the modular devices 5102 in amanner consistent with the derived implications 5256. In the exampleshown in FIG. 87B, the control circuit of the surgical hub 5104interprets how the derived implications 5256 impacts the modular devices5102 and then communicates corresponding control adjustments to each ofthe modular devices 5102. In the example shown in FIG. 87B, the controladjustments include (i) adjusting the compression rate thresholdparameter of the surgical stapling and cutting instrument, (ii)adjusting the visualization threshold value of the surgical hub 5104 toquantify bleeding via the visualization system 108 (FIG. 2) (thisadjustment can apply to the visualization system 108 itself or as aninternal parameter of the surgical hub 5104), (iii) adjusts the powerand control algorithms of the combo generator module 140 (FIG. 3) forthe lung tissue and vessel tissue types, (iv) adjusts the margin rangesof the medical imaging device 124 (FIG. 2) to account for the aggressivecancer type, (v) notifies the surgical stapling and cutting instrumentof the margin parameter adjustment needed (the margin parametercorresponds to the distance or amount of tissue around the cancer thatwill be excised), and (vi) notifies the surgical stapling and cuttinginstrument that the tissue is potentially fragile, which causes thecontrol algorithm of the surgical stapling and cutting instrument toadjust accordingly. Furthermore, the data regarding the implications5256 derived from the anonymized patient data 5254 is considered by thesituational awareness system to infer contextual information 5260regarding the surgical procedure being performed. In the example shownin FIG. 87B, the situational awareness system further infers that theprocedure is a thoracic lung resection 5262, e.g., segmentectomy.

Determining where inefficiencies or ineffectiveness may reside in amedical facility's practice can be challenging because medicalpersonnel's efficiency in completing a surgical procedure, correlatingpositive patient outcomes with particular surgical teams or particulartechniques in performing a type of surgical procedure, and otherperformance measures are not easily quantified using legacy systems. Asone solution, the surgical hubs can be employed to track and store datapertaining to the surgical procedures that the surgical hubs are beingutilized in connection with and generate reports or recommendationsrelated to the tracked data. The tracked data can include, for example,the length of time spent during a particular procedure, the length oftime spent on a particular step of a particular procedure, the length ofdowntime between procedures, modular device(s) (e.g., surgicalinstruments) utilized during the course of a procedure, and the numberand type of surgical items consumed during a procedure (or stepthereof). Further, the tracked data can include, for example, theoperating theater in which the surgical hub is located, the medicalpersonnel associated with the particular event (e.g., the surgeon orsurgical team performing the surgical procedure), the day and time atwhich the particular event(s) occurred, and patient outcomes. This datacan be utilized to create performance metrics, which can be utilized todetect and then ultimately address inefficiencies or ineffectivenesswithin a medical facility's practice. In one exemplification, thesurgical hub includes a situational awareness system, as describedabove, that is configured to infer or determine information regarding aparticular event (e.g., when a particular step of a surgical procedureis being performed and/or how long the step took to complete) based ondata received from data sources connected to the surgical hub (e.g.,paired modular devices). The surgical hub can then store this trackeddata to provide reports or recommendations to users.

Aggregation and Reporting of Surgical Hub Data

FIG. 88 illustrates a block diagram of a computer-implementedinteractive surgical system 5700, in accordance with at least one aspectof the present disclosure. The system 5700 includes a number of surgicalhubs 5706 that, as described above, are able to detect and track datarelated to surgical procedures that the surgical hubs 5706 (and themodular devices paired to the surgical hubs 5706) are utilized inconnection with. In one exemplification, the surgical hubs 5706 areconnected to form local networks such that the data being tracked by thesurgical hubs 5706 is aggregated together across the network. Thenetworks of surgical hubs 5706 can be associated with a medicalfacility, for example. The data aggregated from the network of surgicalhubs 5706 can be analyzed to provide reports on data trends orrecommendations. For example, the surgical hubs 5706 of a first medicalfacility 5704 a are communicably connected to a first local database5708 a and the surgical hubs 5706 of a second medical facility 5704 bare communicably connected to a second local database 5708 b. Thenetwork of surgical hubs 5706 associated with the first medical facility5704 a can be distinct from the network of surgical hubs 5706 associatedwith the second medical facility 5704 b, such that the aggregated datafrom each network of surgical hubs 5706 corresponds to each medicalfacility 5704 a, 5704 b individually. A surgical hub 5706 or anothercomputer terminal communicably connected to the database 5708 a, 5708 bcan be configured to provide reports or recommendations based on theaggregated data associated with the respective medical facility 5704 a,5704 b. In this exemplification, the data tracked by the surgical hubs5706 can be utilized to, for example, report whether a particularincidence of a surgical procedure deviated from the average in-networktime to complete the particular procedure type.

In another exemplification, each surgical hub 5706 is configured toupload the tracked data to the cloud 5702, which then processes andaggregates the tracked data across multiple surgical hubs 5706, networksof surgical hubs 5706, and/or medical facilities 5704 a, 5704 b that areconnected to the cloud 5702. Each surgical hub 5706 can then be utilizedto provide reports or recommendations based on the aggregated data. Inthis exemplification, the data tracked by the surgical hubs 5706 can beutilized to, for example, report whether a particular incidence of asurgical procedure deviated from the average global time to complete theparticular procedure type.

In another exemplification, each surgical hub 5706 can further beconfigured to access the cloud 5702 to compare locally tracked data toglobal data aggregated from all of the surgical hubs 5706 that arecommunicably connected to the cloud 5702. Each surgical hub 5706 can beconfigured to provide reports or recommendations based on the comparisonbetween the tracked local data relative to local (i.e., in-network) orglobal norms. In this exemplification, the data tracked by the surgicalhubs 5706 can be utilized to, for example, report whether a particularincidence of a surgical procedure deviated from either the averagein-network time or the average global time to complete the particularprocedure type.

In one exemplification, each surgical hub 5706 or another computersystem local to the surgical hub 5706 is configured to locally aggregatethe data tracked by the surgical hubs 5706, store the tracked data, andgenerate reports and/or recommendations according to the tracked data inresponse to queries. In cases where the surgical hub 5706 is connectedto a medical facility network (which may include additional surgicalhubs 5706), the surgical hub 5706 can be configured to compare thetracked data with the bulk medical facility data. The bulk medicalfacility data can include EMR data and aggregated data from the localnetwork of surgical hubs 5706. In another exemplification, the cloud5702 is configured to aggregate the data tracked by the surgical hubs5706, store the tracked data, and generate reports and/orrecommendations according to the tracked data in response to queries.

Each surgical hub 5706 can provide reports regarding trends in the dataand/or provide recommendations on improving the efficiency oreffectiveness of the surgical procedures being performed. In variousexemplifications, the data trends and recommendations can be based ondata tracked by the surgical hub 5706 itself, data tracked across alocal medical facility network containing multiple surgical hubs 5706,or data tracked across a number of surgical hubs 5706 communicablyconnected to a cloud 5702. The recommendations provided by the surgicalhub 5706 can describe, for example, particular surgical instruments orproduct mixes to utilize for particular surgical procedures based oncorrelations between the surgical instruments/product mixes and patientoutcomes and procedural efficiency. The reports provided by the surgicalhub 5706 can describe, for example, whether a particular surgicalprocedure was performed efficiently relative to local or global norms,whether a particular type of surgical procedure being performed at themedical facility is being performed efficiently relative to globalnorms, and the average time taken to complete a particular surgicalprocedure or step of a surgical procedure for a particular surgicalteam.

In one exemplification, each surgical hub 5706 is configured todetermine when operating theater events occur (e.g., via a situationalawareness system) and then track the length of time spent on each event.An operating theater event is an event that a surgical hub 5706 candetect or infer the occurrence of. An operating theater event caninclude, for example, a particular surgical procedure, a step or portionof a surgical procedure, or downtime between surgical procedures. Theoperating theater events can be categorized according to an event type,such as a type of surgical procedure being performed, so that the datafrom individual procedures can be aggregated together to form searchabledata sets. FIG. 90 illustrates an example of a diagram 5400 depictingthe data tracked by the surgical hubs 5706 being parsed to provideincreasingly detailed metrics related to surgical procedures or the useof the surgical hub 5706 (as depicted further in FIGS. 91-95) for anillustrative data set. In one exemplification, the surgical hub 5706 isconfigured to determine whether a surgical procedure is being performedand then track both the length of time spent between procedures (i.e.,downtime) and the time spent on the procedures themselves. The surgicalhub 5706 can further be configured to determine and track the time spenton each of the individual steps taken by the medical personnel (e.g.,surgeons, nurses, orderlies) either between or during the surgicalprocedures. The surgical hub can determine when surgical procedures ordifferent steps of surgical procedures are being performed via asituational awareness system, which is described in further detailabove.

FIG. 89 illustrates a logic flow diagram of a process 5300 for trackingdata associated with an operating theater event. In the followingdescription, description of the process 5300, reference should also bemade to FIG. 88. In one exemplification, the process 5300 can beexecuted by a control circuit of a surgical hub 206, as depicted in FIG.10 (processor 244). In yet another exemplification, the process 5300 canbe executed by a distributed computing system including a controlcircuit of a surgical hub 206 in combination with a control circuit of amodular device, such as the microcontroller 461 of the surgicalinstrument depicted FIG. 12, the microcontroller 620 of the surgicalinstrument depicted in FIG. 16, the control circuit 710 of the roboticsurgical instrument 700 depicted in FIG. 17, the control circuit 760 ofthe surgical instruments 750, 790 depicted in FIGS. 18 and 19, or thecontroller 838 of the generator 800 depicted in FIG. 20. For economy,the following description of the process 5300 will be described as beingexecuted by the control circuit of a surgical hub 5706; however, itshould be understood that the description of the process 5300encompasses all of the aforementioned exemplifications.

The control circuit of the surgical hub 5706 executing the process 5300receives 5302 perioperative data from the modular devices and other datasources (e.g., databases and patient monitoring devices) that arecommunicably coupled to the surgical hub 5706. The control circuit thendetermines 5304 whether an event has occurred via, for example, asituational awareness system that derives contextual information fromthe received 5302 data. The event can be associated with an operatingtheater in which the surgical hub 5706 in being used. The event caninclude, for example, a surgical procedure, a step or portion of asurgical procedure, or downtime between surgical procedures or steps ofa surgical procedure. Furthermore, the control circuit tracks dataassociated with the particular event, such as the length of time of theevent, the surgical instruments and/or other medical products utilizedduring the course of the event, and the medical personnel associatedwith the event. The surgical hub 5706 can further determine thisinformation regarding the event via, for example, the situationalawareness system.

For example, the control circuit of a situationally aware surgical hub5706 could determine that anesthesia is being induced in a patientthrough data received from one or more modular devices 5102 (FIG. 81)and/or patient monitoring devices 5124 (FIG. 81). The control circuitcould then determine that the operative portion of the surgicalprocedure has begun upon detecting that an ultrasonic surgicalinstrument or RF electrosurgical instrument has been activated. Thecontrol circuit could thus determine the length of time for theanesthesia inducement step according to the difference in time betweenthe beginning of that particular step and the beginning of the firststep in the operative portion of the surgical procedure. Likewise, thecontrol circuit could determine how long the particular operative stepin the surgical procedure took according to when the control circuitdetects the subsequent step in the procedure begins. Further, thecontrol circuit could determine how long the overall operative portionof the surgical procedure took according to when the control circuitdetects that the final operative step in the procedure ends. The controlcircuit can also determine what surgical instruments (and other modulardevices 5102) are being utilized during the course of each step in thesurgical procedure by tracking the activation and/or use of theinstruments during each of the steps. The control circuit can alsodetect the completion of the surgical procedure by, for example,detecting when the patient monitoring devices 5124 have been removedfrom the patient (as in step fourteen 5228 of FIG. 86). The controlcircuit can then track the downtime between procedures according to whenthe control circuit infers that the subsequent surgical procedure hasbegun.

The control circuit executing the process 5300 then aggregates 5306 thedata associated with the event according to the event type. In oneexemplification, the aggregated 5306 data can be stored in a memory 249(FIG. 10) of the surgical hub 5706. In another exemplification, thecontrol circuit is configured to upload the data associated with theevent to the cloud 5702, whereupon the data is aggregated 5306 accordingto the event type for all of the data uploaded by each of the surgicalhubs 5706 connected to the cloud 5702. In yet another exemplification,the control circuit is configured to upload the data associated with theevent to a database associated with a local network of the surgical hubs5706, whereupon the data is aggregated 5306 according to the event typefor all of the data uploaded across the local network of surgical hubs5706.

In one exemplification, the control circuit is further configured tocompare the data associated with the event type to baseline dataassociated with the event type. The baseline data can correspond to, forexample, average values associated with the particular event type for aparticular hospital, network of hospitals, or across the entirety of thecloud 5702. The baseline data can be stored on the surgical hub 5706 orretrieved by the surgical 5706 as the perioperative data is received5302 thereby.

Aggregating 5306 the data from each of the events according to the eventtype allows individual incidents of the event type to thereafter becompared against the historical or aggregated data to determine whendeviations from the norm for an event type occur. The control circuitfurther determines 5308 whether it has received a query. If the controlcircuit does not receive a query, then the process 5300 continues alongthe NO branch and loops back to continue receiving 5302 data from thedata sources. If the control circuit does receive a query for aparticular event type, the process 5300 continues along the YES branchand the control circuit then retrieves the aggregated data for theparticular event type and displays 5310 the appropriate aggregated datacorresponding to the query. In various exemplifications, the controlcircuit can retrieve the appropriate aggregated data from the memory ofthe surgical hub 5706, the cloud 5702, or a local database 5708 a, 5708b.

In one example, the surgical hub 5706 is configured to determine alength of time for a particular procedure via the aforementionedsituational awareness system according to data received from one or moremodular devices utilized in the performance of the surgical procedure(and other data sources). Each time a surgical procedure is completed,the surgical hub 5706 uploads or stores the length of time required tocomplete the particular type of surgical procedure, which is thenaggregated with the data from every other instance of the type ofprocedure. In some aspects, the surgical hub 5706, cloud 5702, and/orlocal database 5708 a, 5708 b can then determine an average or expectedprocedure length for the particular type of procedure from theaggregated data. When the surgical hub 5706 receives a query as to theparticular type of procedure thereafter, the surgical hub 5706 can thenprovide feedback as to the average (or expected) procedure length orcompare an individual incidence of the procedure type to the averageprocedure length to determine whether the particular incidence deviatestherefrom.

In some aspects, the surgical hub 5706 can be configured toautomatically compare each incidence of an event type to average orexpected norms for the event type and then provide feedback (e.g.,display a report) when a particular incidence of the event type deviatesfrom the norm. For example, the surgical hub 5706 can be configured toprovide feedback whenever a surgical procedure (or a step of thesurgical procedure) deviates from the expected length of time tocomplete the surgical procedure (or the step of the surgical procedure)by more than a set amount.

Referring back to FIG. 90, the surgical hub 5706 could be configured totrack, store, and display data regarding the number of patients operatedon (or procedures completed) per day per operating theater (bar graph5402 depicted further in FIG. 91), for example. The surgical hub 5706could be configured to further parse the number of patients operated on(or procedures completed) per day per operating theater and can befurther parsed according to the downtime between the procedures on agiven day (bar graph 5404 depicted further in FIG. 92) or the averageprocedure length on a given day (bar graph 5408 depicted further in FIG.94). The surgical hub 5706 can be further configured to provide adetailed breakdown of the downtime between procedures according to, forexample, the number and length of the downtime time periods and thesubcategories of the actions or steps during each time period (bar graph5406 depicted further in FIG. 93). The surgical hub 5706 can be furtherconfigured to provide a detailed breakdown of the average procedurelength on a given day according to each individual procedure and thesubcategory of actions or steps during each procedure (bar graph 5410depicted further in FIG. 95). The various graphs shown in FIGS. 90-95can represent data tracked by the surgical hub 5706 and can further begenerated automatically or displayed by the surgical hub 5706 inresponse to queries submitted by users.

FIG. 91 illustrates an example bar graph 5402 depicting the number ofpatients 5420 operated on relative to the days of the week 5422 fordifferent operating rooms 5424, 5426. The surgical hub 5706 can beconfigured to provide (e.g., via a display) the number of patients 5420operated on or procedures that are completed in connection with eachsurgical hub 5706, which can be tracked through a situational awarenesssystem or accessing the hospital's EMR database, for example. In oneexemplification, the surgical hub 5706 can further be configured tocollate this data from different surgical hubs 5706 within the medicalfacility that are communicably connected together, which allows eachindividual surgical hub to present the aggregated data of the medicalfacility on a hub-by-hub or operating theater-by-theater basis. In oneexemplification, the surgical hub 5706 can be configured to compare oneor more tracked metrics to a threshold value (which may be unique toeach tracked metric). When at least one of the tracked metrics exceedsthe threshold value (i.e., either increases above or drops below thethreshold value, as appropriate for the particular tracked metric), thenthe surgical hub 5706 provides a visual, audible, or tactile alert tonotify a user of such. For example, the surgical hub 5706 can beconfigured to indicate when the number of patients or proceduresdeviates from an expected, average, or threshold value. For example,FIG. 91 depicts the number of patients on Tuesday 5428 and Thursday 5430for a first operating theater 5424 as being highlighted for being belowexpectation. Conversely, no days are highlighted for a second operatingtheater 5426 for this particular week, which means in this context thatthe number of patients for each day falls within expectations.

FIG. 92 illustrates a bar graph 5404 depicting the total downtimebetween procedures 5432 relative to the days of a week 5434 for aparticular operating room. The surgical hub 5706 can be configured totrack the length of downtime between surgical procedures through asituational awareness system, for example. The situational awarenesssystem can detect or infer when each particular downtime instance isoccurring and then track the length of time for each instance ofdowntime. The surgical hub 5706 can thereby determine the total downtime5432 for each day of the week 5434 by summing the downtime instances foreach particular day. In one exemplification, the surgical hub 5706 canbe configured to provide an alert when the total length of downtime on agiven day (or another unit of time) deviates from an expected, average,or threshold value. For example, FIG. 92 depicts the total downtime 5432on Tuesday 5436 and Friday 5438 as being highlighted for deviating froman expected length of time.

FIG. 93 illustrates a bar graph 5406 depicting the total downtime 5432per day of the week 5434 as depicted in FIG. 92 broken down according toeach individual downtime instance. The number of downtime instances andthe length of time for each downtime instance can be represented withineach day's total downtime. For example, on Tuesday in the firstoperating theater (OR1) there were four instances of downtime betweenprocedures and the magnitude of the first downtime instance indicatesthat it was longer than the other three instances. In oneexemplification, the surgical hub 5706 is configured to further indicatethe particular actions or steps taken during a selected downtimeinstance. For example, in FIG. 93, Thursday's second downtime instance5440 has been selected, which then causes a callout 5442 to be displayedindicating that this particular downtime instance consisted ofperforming the initial set-up of the operating theater, administeringanesthesia, and prepping the patient. As with the downtime instancesthemselves, the relative size or length of the actions or steps withinthe callout 5442 can correspond to the length of time for eachparticular action or step. The detail views for the downtime instancescan be displayed when a user selects the particular instance, forexample.

FIG. 94 illustrates a bar graph 5408 depicting the average procedurelength 5444 relative to the days of a week 5446 for a particularoperating theater. The surgical hub 5706 can be configured to track theaverage procedure length through a situational awareness system, forexample. The situational awareness system can detect or infer when eachparticular step of a surgical procedure is occurring (see FIG. 86, forexample) and then track the length of time for each of the steps. Thesurgical hub 5706 can thereby determine the total downtime 5432 for eachday of the week 5434 by summing the lengths of the downtime instancesfor the particular day. In one exemplification, the surgical hub 5706can be configured to indicate when the average procedure length deviatesfrom an expected value. For example, FIG. 94 depicts Thursday's averageprocedure length 5448 for the first operating room (OR1) as beinghighlighted for deviating from an expected length of time.

FIG. 95 illustrates a bar graph 5410 depicting the procedure lengths5450 relative to procedure types 5452. The depicted procedure lengths5450 can either represent the average procedure lengths for particulartypes of procedures or the procedure lengths for each individualprocedure performed on a given day in a given operating theater. Theprocedure lengths 5450 for different procedure types 5452 can then becompared. Further, the average lengths for the steps in a procedure type5452 or the length for each particular step in a particular procedurecan be displayed when a procedure is selected. Further, the proceduretypes 5452 can be tagged with various identifiers for parsing andcomparing different data sets. For example, in FIG. 95 the firstprocedure 5454 corresponds to a colorectal procedure (specifically, alow anterior resection) where there was a preoperative identification ofabdominal adhesions. The second procedure 5456 corresponds to a thoracicprocedure (specifically, a segmentectomy). It should be noted again thatthe procedures depicted in FIG. 95 can represent the lengths of time forindividual procedures or the average lengths of time for all of theprocedures for the given procedure types. Each of the procedures canfurther be broken down according to the length of time for each step inthe procedure. For example, FIG. 95 depicts the second procedure 5456 (athoracic segmentectomy) as including an icon or graphical representation5458 of the length of time spent on the dissect vessels, ligate (thevessels), nodal dissection, and closing steps of the surgical procedure.As with the procedure lengths themselves, the relative size or length ofthe steps within the graphical representation 5442 can correspond to thelength of time for each particular step of the surgical procedure. Thedetail views for the steps of the surgical procedures can be displayedwhen a user selects the particular procedure, for example. In oneexemplification, the surgical hub 5706 can be configured to identifywhen a length of time to complete a given step in the procedure deviatesfrom an expected length of time. For example, FIG. 95 depicts the nodaldissection step as being highlighted for deviating from an expectedlength of time.

In one exemplification, an analytics package of the surgical hub 5706can be configured to provide the user with usage data and resultscorrelations related to the surgical procedures (or downtime betweenprocedures). For example, the surgical hub 5706 can be configured todisplay methods or suggestions to improve the efficiency oreffectiveness of a surgical procedure. As another example, the surgicalhub 5706 can be configured to display methods to improve costallocation. FIGS. 96-101 depict examples of various metrics that can betracked by the surgical hub 5706, which can then be utilized to providemedical facility personnel suggestions for inventory utilization ortechnique outcomes. For example, a surgical hub 5706 could provide asurgeon with a suggestion pertaining to a particular technique outcomeprior to or at the beginning of a surgical procedure based on themetrics tracked by the surgical hub 5706.

FIG. 96 illustrates a bar graph 5460 depicting the average completiontime 5462 for particular procedural steps 5464 for different types ofthoracic procedures. The surgical hub 5706 can be configured to trackand store historical data for different types of procedures andcalculate the average time to complete the procedure (or an individualstep thereof). For example, FIG. 96 depicts the average completion time5462 for thoracic segmentectomy 5466, wedge 5468, and lobectomy 5470procedures. For each type of procedure, the surgical hub 5706 can trackthe average time to complete each step thereof. In this particularexample, the dissection, vessel transection, and node dissection stepsare indicated for each type of procedure. In addition to tracking andproviding the average time for the steps of the procedure types, thesurgical hub 5706 can additionally track other metrics or historicaldata, such as the complication rate for each procedure type (i.e., therate of procedures having at least one complication as defined by thesurgical hub 5706 or the surgeon). Additional tracked metrics for eachprocedure type, such as the complication rate, can also be depicted forcomparison between the different procedure types.

FIG. 97 illustrates a bar graph 5472 depicting the procedure time 5474relative to procedure types 5476. The surgical hub 5706 can beconfigured to track and store historical data or metrics for differentprocedure types 5476 or classes, which can encompass multiple subtypesof procedures. For example, FIG. 97 depicts the procedure time 5474 forsurgical procedures classified as a thoracic 5478, bariatric 5480, orcolorectal 5482 procedure. In various exemplifications, the surgical hub5706 can output the procedure time 5474 for the procedureclassifications expressed in terms of either the total length of time orthe average time spent on the given procedure types 5476. The analyticspackage of the surgical hub 5706 can, for example, provide this data tothe surgeons, hospital officials, or medical personnel to track theefficiency of the queried procedures. For example, FIG. 97 depictsbariatric procedures 5480 as taking a lower average time (i.e., beingmore time efficient) than either thoracic procedures 5478 or colorectalprocedures 5482.

FIG. 98 illustrates a bar graph 5484 depicting operating room downtime5486 relative to the time of day 5488. Relatedly, FIG. 99 illustrates abar graph 5494 depicting operating room downtime 5496 relative to theday of the week 5498. Operating room downtime 5486, 5496 can beexpressed in, for example, a length of a unit of time or relativeutilization (i.e., percentage of time that the operating room is inuse). The operating room downtime data can encompass an individualoperating room or an aggregation of multiple operating rooms at amedical facility. As discussed above, a surgical hub 5706 can beconfigured to track whether a surgical procedure is being performed inthe operating theater associated with the surgical hub 5706 (includingthe length of time that a surgical procedure is or is not beingperformed) utilizing a situational awareness system, for example. Asshown in FIGS. 98 and 99, the surgical hub 5706 can provide an output(e.g., bar graphs 5484, 5494 or other graphical representations of data)depicting the tracked data pertaining to when the operating room isbeing utilized (i.e., when a surgical procedure is being performed)and/or when there is downtime between procedures. Such data can beutilized to identify ineffectiveness or inefficiencies in performingsurgical procedures, cleaning or preparing operating theaters forsurgery, scheduling, and other metrics associated with operating theateruse. For example, FIG. 98 depicts a comparative increase in operatingroom downtime 5486 at a first instance 5490 from 11:00 a.m.-12:00 p.m.and a second instance 5492 from 3:00-4:00 p.m. As another example, FIG.99 depicts a comparative increase in operating room downtime 5496 onMondays 5500 and Fridays 5502. In various exemplifications, the surgicalhub 5706 can provide operating theater downtime data for a particularinstance (i.e., a specific time, day, week, etc.) or an averageoperating theater downtime data for a category of instances (i.e.,aggregated data for a day, time, week, etc.). Hospital officials orother medical personnel thus could use this data to identify specificinstances where an inefficiency may have occurred or identify trends inparticular days and/or times of day where there may be inefficiencies.From such data, the hospital officials or other medical personnel couldthen investigate to identify the specific reasons for these increaseddowntimes and take corrective action to address the identified reason.

In various exemplifications, the surgical hub 5706 can be configured todisplay data in response to queries in a variety of different formats(e.g., bar graphs, pie graphs, infographics). FIG. 100 illustrates apair of pie charts depicting the percentage of time that the operatingtheater is utilized. The operating theater utilization percentage canencompass an individual operating theater or an aggregation of multipleoperating theaters (e.g., the operating rooms at a medical facility orevery operating room for all medical facilities having surgical hubs5706 connected to the cloud 5702). As discussed above, a surgical hub5706 can be configured to determine when a surgical procedure is or isnot being performed (i.e., whether the operating theater associated withthe surgical hub 5706 is being utilized) using a situational awarenesssystem, for example. In addition to expressing operating theaterutilization in terms of an average or absolute amount for different timeperiods (as depicted in FIGS. 98-99), the surgical hub 5706 canadditionally express operating theater utilization in terms of apercentage or relative amount compared to a maximum possibleutilization. As above, the operating theater utilization can be parsedfor particular time periods, including the overall utilization (i.e.,the total historical percentage of time in use) for the particularoperating theater (or groups of operating theaters) or the utilizationover the span of a particular time period. As shown in FIG. 100, a firstpie chart 5504 depicts the overall operating theater utilization 5508(85%) and a second pie chart 5506 depicts the operating theaterutilization for the prior week 5510 (75%). Hospital officials and othermedical personnel could use this data to identify that there may havebeen some inefficiency that occurred in the prior week that caused theparticular operating theater (or group of operating theaters) to beutilized less efficiently compared to the historical average so thatfurther investigations can be carried out to identify the specificreasons for this decreased utilization.

In some exemplifications, the surgical hub 5706 is configured to trackdetect and track the number of surgical items that are utilized duringthe course of a surgical procedure. This data can then be aggregated anddisplayed (either automatically or in response to a query) according to,for example, a particular time period (e.g., per day or per week) or fora particular surgical procedure type (e.g., thoracic procedures orabdominal procedures). FIG. 101 illustrates a bar graph 5512 depictingconsumed and unused surgical items 5514 relative to procedure type 5516.The surgical hub 5706 can be configured to determine or infer whatsurgical items are being consumed during the course of each surgicalprocedure via a situational awareness system. The situational awarenesssystem can determine or receive the list of surgical items to be used ina procedure (e.g., see FIG. 85B), determine or infer when each procedure(and steps thereof) begins and ends, and determine when a particularsurgical item is being utilized according to the procedural step beingperformed. The inventory of surgical items that are consumed or unusedduring the course of a surgical procedure can be represented in terms ofthe total number of surgical items or the average number of surgicalitems per procedure type 5516, for example. The consumed surgical itemscan include non-reusable items that are utilized during the course of asurgical procedure. The unused surgical items can include additionalitems that are not utilized during the procedure(s) or scrap items. Theprocedure type can correspond to broad classifications of procedures ora specific procedure type or technique for performing a procedure type.For example, in FIG. 101 the procedure types 5516 being compared arethoracic, colorectal, and bariatric procedures. For each of theseprocedure types 5516, the average number of consumed and unused surgicalitems 5514 are both provided. In one aspect, the surgical hub 5706 canbe configured to further parse the consumed and/or unused surgical items5514 by the specific item type. In one exemplification, the surgical hub5706 can provide a detailed breakdown of the surgical items 5514 makingup each item category for each surgical procedure type 5516 andgraphically represent the different categories of surgical items 5514.For example, in FIG. 101, the unused surgical items are depicted indashed lines and the consumed surgical items are depicted in solidlines. In one exemplification, the surgical hub 5706 is configured tofurther indicate the specific within a category for a particularprocedure type 5516. For example, in FIG. 93, the consumed itemscategory for the thoracic procedure type has been selected, which thencauses a callout 5520 to be displayed listing the particular surgicalitems in the category: stapler cartridges, sponges, saline, fibrinsealants, surgical sutures, and stapler buttress material. Furthermore,the callout 5520 can be configured to provide the quantities of thelisted items in the category, which may be the average or absolutequantities of the items (either consumed or unused) for the particularprocedure type.

In one exemplification, the surgical hub 5706 can be configured toaggregate tracked data in a redacted format (i.e., with anypatient-identifying information stripped out). Such bulk data can beutilized for academic or business analysis purposes. Further, thesurgical hub 5706 can be configured to upload the redacted or anonymizeddata to a local database of the medical facility in which the surgicalhub 5706 is located, an external database system, or the cloud 5702,whereupon the anonymized data can be accessed by user/clientapplications on demand. The anonymized data can be utilized to compareoutcomes and efficiencies within a hospital or between geographicregions, for example.

The process 5300 depicted in FIG. 89 improves scheduling efficiency byallowing the surgical hubs 5706 to automatically store and providegranular detail on correlations between lengths of time required forvarious procedures according to particular days, particular types ofprocedures, particular hospital staff members, and other such metrics.This process 5300 also reduces surgical item waste by allowing thesurgical hubs 5706 to provide alerts when the amount of surgical itemsbeing consumed, either on a per-procedure basis or as a category, aredeviating from the expected amounts. Such alerts can be provided eitherautomatically or in response to receiving a query.

FIG. 102 illustrates a logic flow diagram of a process 5350 for storingdata from the modular devices and patient information database forcomparison. In the following description, description of the process5350, reference should also be made to FIG. 88. In one exemplification,the process 5350 can be executed by a control circuit of a surgical hub206, as depicted in FIG. 10 (processor 244). In yet anotherexemplification, the process 5350 can be executed by a distributedcomputing system including a control circuit of a surgical hub 206 incombination with a control circuit of a modular device, such as themicrocontroller 461 of the surgical instrument depicted FIG. 12, themicrocontroller 620 of the surgical instrument depicted in FIG. 16, thecontrol circuit 710 of the robotic surgical instrument 700 depicted inFIG. 17, the control circuit 760 of the surgical instruments 750, 790depicted in FIGS. 18 and 19, or the controller 838 of the generator 800depicted in FIG. 20. For economy, the following description of theprocess 5350 will be described as being executed by the control circuitof a surgical hub 5706; however, it should be understood that thedescription of the process 5350 encompasses all of the aforementionedexemplifications.

The control circuit executing the process 5350 receives data from thedata sources, such as the modular device(s) and the patient informationdatabase(s) (e.g., EMR databases) that are communicably coupled to thesurgical hub 5706. The data from the modular devices can include, forexample, usage data (e.g., data pertaining to how often the modulardevice has been utilized, what procedures the modular device has beenutilized in connection with, and who utilized the modular devices) andperformance data (e.g., data pertaining to the internal state of themodular device and the tissue being operated on). The data from thepatient information databases can include, for example, patient data(e.g., data pertaining to the patient's age, sex, and medical history)and patient outcome data (e.g., data pertaining to the outcomes from thesurgical procedure). In some exemplifications, the control circuit cancontinuously receive 5352 data from the data sources before, during, orafter a surgical procedure.

As the data is received 5352, the control circuit aggregates 5354 thedata in comparison groups of types of data. In other words, the controlcircuit causes a first type of data to be stored in association with asecond type of data. However, more than two different types of data canbe aggregated 5354 together into a comparison group. For example, thecontrol circuit could store a particular type of performance data for aparticular type of modular device (e.g., the force to fire for asurgical cutting and stapling instrument or the characterization of theenergy expended by an RF or ultrasonic surgical instrument) inassociation with patient data, such as sex, age (or age range), acondition (e.g., emphysema) associated with the patient. In oneexemplification, when the data is aggregated 5354 into comparisongroups, the data is anonymized such that all patient-identifyinginformation is removed from the data. This allows the data aggregated5354 into comparison groups to be utilized for studies, withoutcompromising confidential patient information. The various types of datacan be aggregated 5354 and stored in association with each other inlookup tables, arrays, and other such formats. In one exemplification,the received 5352 data is automatically aggregated 5354 into comparisongroups. Automatically aggregating 5354 and storing the data allows thesurgical hub 5706 to quickly return results for queries and the groupsof data to be exported for analysis according to specifically desireddata types.

When the control circuit receives 5356 a query for a comparison betweentwo or more of the tracked data types, the process 5350 proceeds alongthe YES branch. The control circuit then retrieves the particularcombination of the data types stored in association with each other andthen displays 5358 a comparison (e.g., a graph or other graphicalrepresentation of the data) between the subject data types. If thecontrol circuit does not receive 5356 a query, the process 5350continues along the NO branch and the control circuit continuesreceiving 5352 data from the data sources.

In one exemplification, the control circuit can be configured toautomatically quantify a correlation between the received 5352 datatypes. In such aspects, the control circuit can calculate a correlationcoefficient (e.g., the Pearson's coefficient) between pairs of datatypes. In one aspect, the control circuit can be configured toautomatically display a report providing suggestions or other feedbackif the quantified correlation exceeds a particular threshold value. Inone aspect, the control circuit of the surgical hub 5706 can beconfigured to display a report on quantified correlations exceeding aparticular threshold value upon receiving a query or request from auser.

In one exemplification, a surgical hub 5706 can compile information onprocedures that the surgical hub 5706 was utilized in the performanceof, communicate with other surgical hubs 5706 within its network (e.g.,a local network of a medical facility or a number of surgical hubs 5706connected by the cloud 5702), and compare results between type ofsurgical procedures or particular operating theaters, doctors, ordepartments. Each surgical hub 5706 can calculate and analyzeutilization, efficiency, and comparative results (relative to allsurgical hubs 5706 across a hospital network, a region, etc.). Forexample, the surgical hub 5706 can display efficiency and comparativedata, including operating theater downtime, operating theater clean-upand recycle time, step-by-step completion timing for procedures(including highlighting which procedural steps take the longest, forexample), average times for surgeons to complete procedures (includingparsing the completion times on a procedure-by-procedure basis),historical completion times (e.g., for completing classes of procedures,specific procedures, or specific steps within a procedure), and/oroperating theater utilization efficiency (i.e., the time efficiency froma procedure to a subsequent procedure). The data that is accessed andshared across networks by the surgical hubs 5706 can include theanonymized data aggregated into comparison groups, as discussed above.

For example, the surgical hub 5706 can be utilized to perform studies ofperformance by instrument type or cartridge type for various procedures.As another example, the surgical hub 5706 can be utilized to performstudies on the performance of individual surgeons. As yet anotherexample, the surgical hub 5706 can be utilized to perform studies on theeffectiveness of different surgical procedures according to patients'characteristics or disease states.

In another exemplification, a surgical hub 5706 can provide suggestionson streamlining processes based on tracked data. For example, thesurgical hub 5706 can suggest different product mixes according to thelength of certain procedures or steps within a procedure (e.g., suggesta particular item that is more appropriate for long procedure steps),suggest more cost effective product mixes based on the utilization ofitems, and/or suggest kitting or pre-grouping certain items to lowerset-up time. In another exemplification, a surgical hub 5706 can compareoperating theater utilization across different surgical groups in orderto better balance high volume surgical groups with surgical groups thathave more flexible bandwidth. In yet another aspect, the surgical hub5706 could be put in a forecasting mode that would allow the surgicalhub 5706 to monitor upcoming procedure preparation and scheduling, thennotify the administration or department of upcoming bottlenecks or allowthem to plan for scalable staffing. The forecasting mode can be basedon, for example, the anticipated future steps of the current surgicalprocedure that is being performed using the surgical hub 5706, which canbe determined by a situational awareness system.

In another exemplification, a surgical hub 5706 can be utilized as atraining tool to allow users to compare their procedure timing to othertypes of individuals or specific individuals within their department(e.g., a resident could compare his or her timing to a particularspecialist or the average time for a specialist within the hospital) orthe department average times. For example, users could identify whatsteps of a surgical procedure they are spending an inordinate amount oftime on and, thus, what steps of the surgical procedure that they needto improve upon.

In one exemplification, all processing of stored data is performedlocally on each surgical hub 5706. In another exemplification, eachsurgical hub 5706 is part of a distributed computing network, whereineach individual surgical hub 5706 compiles and analyzes its stored dataand then communicates the data to the requesting surgical hub 5706. Adistributed computing network could permit fast parallel processing. Inanother exemplification, each surgical hub 5706 is communicablyconnected to a cloud 5702, which can be configured to receive the datafrom each surgical hub 5706 and then perform the necessary processing(data aggregation, calculations, and so on) on the data.

The process 5350 depicted in FIG. 102 improves the ability to determinewhen procedures are being performed inefficiently by allowing thesurgical hubs 5706 to provide alerts when particular procedures, eitheron a per-procedure basis or as category, are deviating from the expectedtimes to complete the procedures. Such alerts can be provided eitherautomatically or in response to receiving a query. This process 5350also improves the ability to perform studies on what surgicalinstruments and surgical procedure techniques provide the best patientoutcomes by automatically tracking and indexing such data ineasily-retrievable and reportable formats.

Some systems described herein offload the data processing that controlsthe modular devices (e.g., surgical instruments) from the modulardevices themselves to an external computing system (e.g., a surgicalhub) and/or a cloud. However in some exemplifications, some modulardevices can sample data (e.g., from the sensors of the surgicalinstruments) at a faster rate that the rate at which the data can betransmitted to and processed by a surgical hub. As one solution, thesurgical hub and the surgical instruments (or other modular devices) canutilize a distributed computing system where at least a portion of thedata processing is performed locally on the surgical instrument. Thiscan avoid data or communication bottlenecks between the instrument andthe surgical hub by allowing the onboard processor of the surgicalinstrument to handle at least some of the data processing when the datasampling rate is exceeding the rate at which the data can be transmittedto the surgical hub. In some exemplifications, the distributed computingsystem can cease distributing the processing between the surgical huband the surgical instrument and instead have the processing be executedsolely onboard the surgical instrument. The processing can be executedsolely by the surgical instrument in situations where, for example, thesurgical hub needs to allocate its processing capabilities to othertasks or the surgical instrument is sampling data at a very high rateand it has the capabilities to execute all of the data processingitself.

Similarly, the data processing for controlling the modular devices, suchas surgical instruments, can be taxing for an individual surgical hub toperform. If the surgical hub's processing of the control algorithms forthe modular devices cannot keep pace with the use of the modulardevices, then the modular devices will not perform adequately becausetheir control algorithms will either not be updated as needed or theupdates to the control algorithms will lag behind the actual use of theinstrument. As one solution, the surgical hubs can be configured toutilize a distributed computing system where at least a portion of theprocessing is performed across multiple separate surgical hubs. This canavoid data or communication bottlenecks between the modular devices andthe surgical hub by allowing each surgical hub to utilize the networkedprocessing power of multiple surgical hubs, which can increase the rateat which the data is processed and thus the rate at which the controlalgorithm adjustments can be transmitted by the surgical hub to thepaired modular devices. In addition to distributing the computingassociated with controlling the various modular devices connected to thesurgical hubs, a distributed computing system can also dynamically shiftcomputing resources between multiple surgical hubs in order to analyzetracked data in response to queries from users and perform other suchfunctions. The distributed computing system for the surgical hubs canfurther be configured to dynamically shift data processing resourcesbetween the surgical hubs when any particular surgical hub becomesovertaxed.

The modular devices that are communicably connectable to the surgicalhub can include sensors, memories, and processors that are coupled tothe memories and configured to receive and analyze data sensed by thesensors. The surgical hub can further include a processor coupled to amemory that is configured to receive (through the connection between themodular device and the surgical hub) and analyze the data sensed by thesensors of the modular device. In one exemplification, the data sensedby the modular device is processed externally to the modular device(e.g., external to a handle assembly of a surgical instrument) by acomputer that is communicably coupled to the modular device. Forexample, the advanced energy algorithms for controlling the operation ofa surgical instrument can be processed by an external computing system,rather than on a controller embedded in the surgical instrument (such asinstrument using an Advanced RISC Machine (ARM) processor). The externalcomputer system processing the data sensed by the modular devices caninclude the surgical hub to which the modular devices are paired and/ora cloud computing system. In one exemplification, data sampled at aparticular rate (e.g., 20 Ms/sec) and a particular resolution (e.g., 12bits resolution) by a surgical instrument is decimated and thentransmitted over a link to the surgical hub to which the surgicalinstrument is paired. Based on this received data, the control circuitof the surgical hub then determines the appropriate control adjustmentsfor the surgical instrument, such as controlling power for an ultrasonicsurgical instrument or RF electrosurgical instrument, setting motortermination points for a motor-driven surgical instrument, and so on.The control adjustments are then transmitted to the surgical instrumentfor application thereon.

Distributed Processing

FIG. 103 illustrates a diagram of a distributed computing system 5600.The distributed computing system 5600 includes a set of nodes 5602 a,5602 b, 5602 c that are communicably coupled by a distributedmulti-party communication protocol such that they execute a shared ordistributed computer program by passing messages therebetween. Althoughthree nodes 5602 a, 5602 b, 5602 c are depicted, the distributedcomputing system 5600 can include any number of nodes 5602 a, 5602 b,5602 c that are communicably connected together. Each of the nodes 5602a, 5602 b, 5602 c comprises a respective memory 5606 a, 5606 b, 5606 cand processor 5604 a, 5604 b, 5604 c coupled thereto. The processors5604 a, 5604 b, 5604 c execute the distributed multi-party communicationprotocol, which is stored at least partially in the memories 5606 a,5606 b, 5606 c. Each node 5602 a, 5602 b, 5602 c can represent either amodular device or a surgical hub. Therefore, the depicted diagramrepresents aspects wherein various combinations of surgical hubs and/ormodular devices are communicably coupled. In various exemplifications,the distributed computing system 5600 can be configured to distributethe computing associated with controlling the modular device(s) (e.g.,advanced energy algorithms) over the modular device(s) and/or thesurgical hub(s) to which the modular device(s) are connected. In otherwords, the distributed computing system 5600 embodies a distributedcontrol system for controlling the modular device(s) and/or surgicalhub(s).

In some exemplifications, the modular device(s) and surgical hub(s)utilize data compression for their communication protocols. Wirelessdata transmission over sensor networks can consume a significant amountof energy and/or processing resources compared to data computation onthe device itself. Thus data compression can be utilized to reduce thedata size at the cost of extra processing time on the device. In oneexemplification, the distributed computing system 5600 utilizes temporalcorrelation for sensing data, data transformation from one dimension totwo dimension, and data separation (e.g., upper 8 bit and lower 8 bitdata). In another exemplification, the distributed computing system 5600utilizes a collection tree protocol for data collection from differentnodes 5602 a, 5602 b, 5602 c having sensors (e.g., modular devices) to aroot node. In yet another aspect, the distributed computing system 5600utilizes first-order prediction coding to compress the data collected bythe nodes 5602 a, 5602 b, 5602 c having sensors (e.g., modular devices),which can minimize the amount of redundant information and greatlyreduce the amount of data transmission between the nodes 5602 a, 5602 b,5602 c of the network. In yet another exemplification, the distributedcomputing system 5600 is configured to transmit only theelectroencephalogram (EEG) features. In still yet anotherexemplification, the distributed computing system 5600 can be configuredto transmit only the complex data features that are pertinent to thesurgical instrument detection, which can save significant power inwireless transmission. Various other exemplifications can utilizecombinations of the aforementioned data compression techniques and/oradditional techniques of data compression.

FIG. 104 illustrates a logic flow diagram of a process 5650 for shiftingdistributed computing resources. In the following description of the5650, reference should also be made to FIG. 103. In one exemplification,the process 5650 can be executed by a distributed computing systemincluding a control circuit of a surgical hub 206, as depicted in FIG.10 (processor 244), in combination with a control circuit of a secondsurgical hub 206 and/or a control circuit of a modular device, such asthe microcontroller 461 of the surgical instrument depicted FIG. 12, themicrocontroller 620 of the surgical instrument depicted in FIG. 16, thecontrol circuit 710 of the robotic surgical instrument 700 depicted inFIG. 17, the control circuit 760 of the surgical instruments 750, 790depicted in FIGS. 18 and 19, or the controller 838 of the generator 800depicted in FIG. 20. For economy, the following description of theprocess 5650 will be described as being executed by the control circuitsof one or more nodes; however, it should be understood that thedescription of the process 5650 encompasses all of the aforementionedexemplifications.

The control circuits of each node execute 5652 a distributed controlprogram in synchrony. As the distributed control program is beingexecuted across the network of nodes, at least one of the controlcircuits monitors for a command instructing the distributed computingsystem to shift from a first mode, wherein the distributed computingprogram is executed across the network of nodes, to a second mode,wherein the control program is executed by a single node. In oneexemplification, the command can be transmitted by a surgical hub inresponse to the surgical hub's resources being needed for an alternativecomputing task. In another exemplification, the command can betransmitted by a modular device in response to the rate at which thedata is sampled by the modular device outpacing the rate at which thesampled data can be communicated to the other nodes in the network. If acontrol circuit determines that an appropriate command has been received5654, the process 5650 continues along the YES branch and thedistributed computing system 5600 shifts to a single node executing 5656the program. For example, the distributed computing system 5600 shiftsthe distributed computing program from being executed by both a modulardevice and a surgical hub to being executed solely by the modulardevice. As another example, the distributed computing system 5600 shiftsthe distributed computing program from being executed by both a firstsurgical hub and a second surgical hub to being executed solely by thefirst surgical hub. If no control circuit determines that an appropriatecommand has been received 5654, the process continues along the NObranch and the control circuits of the network of nodes continuesexecuting 5652 the distributed computing program across the network ofnodes.

In the event that the program has been shifted to being executed 5656 bya single node, the control circuit of the particular node solelyexecuting the distributed program and/or a control circuit of anothernode within the network (which previously was executing the distributedprogram) monitors for a command instructing the node to re-distributethe processing of the program across the distributed computing system.In other words, the node monitors for a command to re-initiate thedistributed computing system. In one exemplification, the command tore-distribute the processing across the network can be generated whenthe sampling rate of the sensor is less than the data communication ratebetween the modular device and the surgical hub. If a control circuitreceives 5658 an appropriate command to re-distribute the processing,then the process 5650 proceeds along the YES branch and the program isonce again executed 5652 across the node network. If a control circuithas not received 5658 an appropriate command, then the node continuessingularly executing 5656 the program.

The process 5650 depicted in FIG. 104 eliminates data or communicationbottlenecks in controlling modular devices by utilizing a distributedcomputing architecture that can shift computing resources either betweenthe modular devices and surgical hubs or between the surgical hubs asneeded. This process 5650 also improves the modular devices' dataprocessing speed by allowing the processing of the modular devices'control adjustments to be executed at least in part by the modulardevices themselves. This process 5650 also improves the surgical hubs'data processing speed by allowing the surgical hubs to shift computingresources between themselves as necessary.

It can be difficult during video-assisted surgical procedures, such aslaparoscopic procedures, to accurately measure sizes or dimensions offeatures being viewed through a medical imaging device due to distortiveeffects caused by the device's lens. Being able to accurately measuresizes and dimensions during video-assisted procedures could assist asituational awareness system for a surgical hub by allowing the surgicalhub to accurately identify organs and other structures duringvideo-assisted surgical procedures. As one solution, a surgical hubcould be configured to automatically calculate sizes or dimensions ofstructures (or distances between structures) during a surgical procedureby comparing the structures to markings affixed to devices that areintended to be placed within the FOV of the medical imaging deviceduring a surgical procedure. The markings can represent a known scale,which can then be utilized to make measurements by comparing the unknownmeasured length to the known scale.

In one exemplification, the surgical hub is configured to receive imageor video data from a medical imaging device paired with the surgicalhub. When a surgical instrument bearing a calibration scale is withinthe FOV of the medical imaging device, the surgical hub is able tomeasure organs and other structures that are likewise within the medicalimaging device's FOV by comparing the structures to the calibrationscale. The calibration scale can be positioned on, for example, thedistal end of a surgical instrument.

FIG. 105 illustrates a diagram of an imaging system 5800 and a surgicalinstrument 5806 bearing a calibration scale 5808. The imaging system5800 includes a medical imaging device 5804 that is paired with asurgical hub 5802. The surgical hub 5802 can include a patternrecognition system or a machine learning system configured to recognizefeatures in the FOV from image or video data received from the medicalimaging device 5804. In one exemplification, a surgical instrument 5806(e.g., a surgical cutting and stapling instrument) that is intended toenter the FOV of the medical imaging device 5804 during a surgicalprocedure includes a calibration scale 5808 affixed thereon. Thecalibration scale 5808 can be positioned on the exterior surface of thesurgical instrument 5806, for example. In aspects wherein the surgicalinstrument 5806 is a surgical cutting and stapling instrument, thecalibration scale 5808 can be positioned along the exterior surface ofthe anvil. The calibration scale 5808 can include a series of graphicalmarkings separated at fixed and/or known intervals. The distance betweenthe end or terminal markings of the calibration scale 5808 can likewisebe a set distance L (e.g., 35 mm). In one exemplification, the endmarkings (e.g., the most proximal marking and the most distal marking)of the calibration scale 5808 are differentiated from the intermediatemarkings in size, shape, color, or another such fashion. This allows theimage recognition system of the surgical hub 5802 to identify the endmarkings separately from the intermediate markings. The distance(s)between the markings can be stored in a memory or otherwise retrieved bythe surgical hub 5802. The surgical hub 5802 can thus measure lengths orsizes of structures relative to the provided calibration scale 5808. InFIG. 105, for example, the surgical hub 5802 can calculate that theartery 5810 a has a diameter or width of D1 (e.g., 17.0 mm), the vein5810 b has a diameter or width of D2 (e.g., 17.5 mm), and the distancebetween the vessels is D3 (e.g., 20 mm) by comparing the visualizationsof these distances D1, D2, D3 to the known length L of the calibrationscale 5808 positioned on the surgical instrument 5806 within the FOV ofthe medical imaging device 5804. The surgical hub 5802 can recognize thepresence of the vessels 5810 a, 5810 b via an image recognition system.In some exemplifications, the surgical hub 5802 can be configured toautomatically measure and display the size or dimension of detectedfeatures within the FOV of the medical imaging device 5804. In someexemplifications, the surgical hub 5802 can be configured to calculatethe distance between various points selected by a user on an interactivedisplay that is paired with the surgical hub 5802.

The imaging system 5800 configured to detect and measure sizes accordingto a calibration scale 5808 affixed to surgical instruments 5806provides the ability to accurately measure sizes and distances duringvideo-assisted procedures. This can make it easier for surgeons toprecisely perform video-assisted procedures by compensating for theoptically distortive effects inherent in such procedures.

User Feedback Methods

The present disclosure provides user feedback techniques. In one aspect,the present disclosure provides a display of images through a medicalimaging device (e.g., laparoscope, endoscope, thoracoscope, and thelike). A medical imaging device comprises an optical component and animage sensor. The optical component may comprise a lens and a lightsource, for example. The image sensor may be implemented as a chargecoupled device (CCD) or complementary oxide semiconductor (CMOS). Theimage sensor provides image data to electronic components in thesurgical hub. The data representing the images may be transmitted bywired or wireless communication to display instrument status, feedbackdata, imaging data, and highlight tissue irregularities and underliningstructures. In another aspect, the present disclosure provides wired orwireless communication techniques for communicating user feedback from adevice (e.g., instrument, robot, or tool) to the surgical hub. Inanother aspect, the present disclosure provides identification and usagerecording and enabling. Finally, in another aspect, the surgical hub mayhave a direct interface control between the device and the surgical hub.

Through Laparoscope Monitor Display of Data

In various aspects, the present disclosure provides through laparoscopemonitor display of data. The through laparoscope monitor display of datamay comprise displaying a current instrument alignment to adjacentprevious operations, cooperation between local instrument displays andpaired laparoscope display, and display of instrument specific dataneeded for efficient use of an end-effector portion of a surgicalinstrument. Each of these techniques is described hereinbelow.

Display of Current Instrument Alignment to Adjacent Previous Operations

In one aspect, the present disclosure provides alignment guidancedisplay elements that provide the user information about the location ofa previous firing or actuation and allow them to align the nextinstrument use to the proper position without the need for seeing theinstrument directly. In another aspect, the first device and seconddevice and are separate; the first device is within the sterile fieldand the second is used from outside the sterile field.

During a colorectal transection using a double-stapling technique it isdifficult to align the location of an anvil trocar of a circular staplerwith the center of an overlapping staple line. During the procedure, theanvil trocar of the circular stapler is inserted in the rectum below thestaple line and a laparoscope is inserted in the peritoneal cavity abovethe staple line. Because the staple line seals off the colon, there isno light of sight to align the anvil trocar using the laparoscope tooptically align the anvil trocar insertion location relative to thecenter of the staple line overlap.

One solution provides a non-contact sensor located on the anvil trocarof the circular stapler and a target located at the distal end of thelaparoscope. Another solution provides a non-contact sensor located atthe distal end of the laparoscope and a target located on the anviltrocar of the circular stapler.

A surgical hub computer processor receives signals from the non-contactsensor and displays a centering tool on a screen indicating thealignment of the anvil trocar of the circular stapler and the overlapportion at the center of staple line. The screen displays a first imageof the target staple line with a radius around the staple line overlapportion and a second image of the projected anvil trocar location. Theanvil trocar and the overlap portion at the center of staple line arealigned when the first and second images overlap.

In one aspect, the present disclosure provides a surgical hub foraligning a surgical instrument. The surgical hub comprises a processorand a memory coupled to the processor. The memory stores instructionsexecutable by the processor to receive image data from an image sensor,generate a first image based on the image data, display the first imageon a monitor coupled to the processor, receive a signal from anon-contact sensor, generate a second image based on the position of thesurgical device, and display the second image on the monitor. The firstimage data represents a center of a staple line seal. The first imagerepresents a target corresponding to the center of the staple line. Thesignal is indicative of a position of a surgical device relative to thecenter of the staple line. The second image represents the position ofthe surgical device along a projected path of the surgical device towardthe center of the staple line.

In one aspect, the center of the staple line is a double-staple overlapportion zone. In another aspect, the image sensor receives an image froma laparoscope. In another aspect, the surgical device is a circularstapler comprising an anvil trocar and the non-contact sensor isconfigured to detect the location of the anvil trocar relative to thecenter of the staple line seal. In another aspect, the non-contactsensor is an inductive sensor. In another aspect, the non-contact sensoris a capacitive sensor.

In various aspects, the present disclosure provides a control circuit toalign the surgical instrument as described above. In various aspects,the present disclosure provides a non-transitory computer readablemedium storing computer readable instructions which, when executed,causes a machine to align the surgical instrument as described above.

This technique provides better alignment of a surgical instrument suchas a circular stapler about the overlap portion of the staple line toproduce a better seal and cut after the circular stapler is fired.

In one aspect, the present disclosure provides a system for displayingthe current instrument alignment relative to prior adjacent operations.The instrument alignment information may be displayed on a monitor orany suitable electronic device suitable for the visual presentation ofdata whether located locally on the instrument or remotely from theinstrument through the modular communication hub. The system may displaythe current alignment of a circular staple cartridge to an overlappingstaple line, display the current alignment of a circular staplecartridge relative to a prior linear staple line, and/or show theexisting staple line of the linear transection and an alignment circleindicating an appropriately centered circular staple cartridge. Each ofthese techniques is described hereinbelow.

In one aspect, the present disclosure provides alignment guidancedisplay elements that provide the user information about the location ofa previous firing or actuation of a surgical instrument (e.g., surgicalstapler) and allows the user to align the next instrument use (e.g.,firing or actuation of the surgical stapler) to the proper positionwithout the need for seeing the instrument directly. In another aspect,the present disclosure provides a first device and a second device thatis separate from the first device. The first device is located within asterile field and the second is located outside the sterile field. Thetechniques described herein may be applied to surgical staplers,ultrasonic instruments, electrosurgical instruments, combinationultrasonic/electrosurgical instruments, and/or combination surgicalstapler/electrosurgical instruments.

FIG. 106 illustrates a diagram 6000 of a surgical instrument 6002centered on a staple line 6003 using the benefit of centering tools andtechniques described in connection with FIGS. 23-33, according to oneaspect of the present disclosure. As used in the following descriptionof FIGS. 107-117 a staple line may include multiple rows of staggeredstaples and typically includes two or three rows of staggered staples,without limitation. The staple line may be a double staple line 6004formed using a double-stapling technique as described in connection withFIGS. 107-111 or may be a linear staple line 6052 formed using a lineartransection technique as described in connection with FIGS. 112-117. Thecentering tools and techniques described herein can be used to align theinstrument 6002 located in one part of the anatomy with either thestaple line 6003 or with another instrument located in another part ofthe anatomy without the benefit of a line of sight. The centering toolsand techniques include displaying the current alignment of theinstrument 6002 adjacent to previous operations. The centering tool isuseful, for example, during laparoscopic-assisted rectal surgery thatemploy a double-stapling technique, also referred to as an overlappingstapling technique. In the illustrated example, during alaparoscopic-assisted rectal surgical procedure, a circular stapler 6002is positioned in the rectum 6006 of a patient within the pelvic cavity6008 and a laparoscope is positioned in the peritoneal cavity.

During the laparoscopic-assisted rectal surgery, the colon is transectedand sealed by the staple line 6003 having a length “1.” Thedouble-stapling technique uses the circular stapler 6002 to create anend-to-end anastomosis and is currently used widely inlaparoscopic-assisted rectal surgery. For a successful formation of ananastomosis using a circular stapler 6002, the anvil trocar 6010 of thecircular stapler 6002 should be aligned with the center “½” of thestaple line 6003 transection before puncturing through the center “½” ofthe staple line 6003 and/or fully clamping on the tissue before firingthe circular stapler 6002 to cut out the staple overlap portion 6012 andforming the anastomosis. Misalignment of the anvil trocar 6010 to thecenter of the staple line 6003 transection may result in a high rate ofanastomotic failures. This technique may be applied to ultrasonicinstruments, electrosurgical instruments, combinationultrasonic/electrosurgical instruments, and/or combination surgicalstapler/electrosurgical instruments. Several techniques are nowdescribed for aligning the anvil trocar 6010 of the circular stapler6002 to the center “½” of the staple line 6003.

In one aspect, as described in FIGS. 107-109 and with reference also toFIGS. 1-11 to show interaction with an interactive surgical system 100environment including a surgical hub 106, 206, the present disclosureprovides an apparatus and method for detecting the overlapping portionof the double staple line 6004 in a laparoscopic-assisted rectal surgerycolorectal transection using a double stapling technique. Theoverlapping portion of the double staple line 6004 is detected and thecurrent location of the anvil trocar 6010 of the circular stapler 6002is displayed on a surgical hub display 215 coupled to the surgical hub206. The surgical hub display 215 displays the alignment of a circularstapler 6002 cartridge relative to the overlapping portion of the doublestaple line 6004, which is located at the center of the double stapleline 6004. The surgical hub display 215 displays a circular imagecentered around the overlapping double staple line 6004 region to ensurethat the overlapping portion of the double staple line 6004 is containedwithin the knife of the circular stapler 6002 and therefore removedfollowing the circular firing. Using the display, the surgeon aligns theanvil trocar 6010 with the center of the double staple line 6004 beforepuncturing through the center of the double staple line 6004 and/orfully clamping on the tissue before firing the circular stapler 6002 tocut out the staple overlap portion 6012 and form the anastomosis.

FIGS. 107-109 illustrate a process of aligning an anvil trocar 6010 of acircular stapler 6022 to a staple overlap portion 6012 of a doublestaple line 6004 created by a double-stapling technique, according toone aspect of the present disclosure. The staple overlap portion 6012 iscentered on the double staple line 6004 formed by a double-staplingtechnique. The circular stapler 6002 is inserted into the colon 6020below the double staple line 6004 and a laparoscope 6014 is insertedthrough the abdomen above the double staple line 6004. A laparoscope6014 and a non-contact sensor 6022 are used to determine an anvil trocar6010 location relative to the staple overlap portion 6012 of the doublestaple line 6004. The laparoscope 6014 includes an image sensor togenerate an image of the double staple line 6004. The image sensor imageis transmitted to the surgical hub 206 via the imaging module 238. Thesensor 6022 generates a signal 6024 that detects the metal staples usinginductive or capacitive metal sensing technology. The signal 6024 variesbased on the position of the anvil trocar 6010 relative to the stapleoverlap portion 6004. A centering tool 6030 presents an image 6038 ofthe double staple line 6004 and a target alignment ring 6032circumscribing the image 6038 of the double staple line 6004 centeredabout an image 6040 of the staple overlap portion 6012 on the surgicalhub display 215. The centering tool 6030 also presents a projected cutpath 6034 of an anvil knife of the circular stapler 6002. The alignmentprocess includes displaying an image 6038 of the double staple line 6004and a target alignment ring 6032 circumscribing the image 6038 of thedouble staple line 6004 centered on the image 6040 of the staple overlapportion 6012 to be cut out by the circular knife of the circular stapler6002. Also displayed is an image of a crosshair 6036 (X) relative to theimage 6040 of the staple overlap portion 6012.

FIG. 107 illustrates an anvil trocar 6010 of a circular stapler 6002that is not aligned with a staple overlap portion 6012 of a doublestaple line 6004 created by a double-stapling technique. The doublestaple line 6004 has a length “1” and the staple overlap portion 6012 islocated midway along the double staple line 6004 at “½.” As shown inFIG. 107, the circular stapler 6002 is inserted into a section of thecolon 6020 and is positioned just below the double staple line 6004transection. A laparoscope 6014 is positioned above the double stapleline 6004 transection and feeds an image of the double staple line 6004and staple overlap portion 6012 within the field of view 6016 of thelaparoscope 6014 to the surgical hub display 215. The position of theanvil trocar 6010 relative to the staple overlap portion 6012 isdetected by a sensor 6022 located on the circular stapler 6002. Thesensor 6022 also provides the position of the anvil trocar 6010 relativeto the staple overlap portion 6012 to the surgical hub display 215.

As shown in FIG. 107, the projected path 6018 of the anvil trocar 6010is shown along a broken line to a position marked by an X. As shown inFIG. 107, the projected path 6018 of the anvil trocar 6010 is notaligned with the staple overlap portion 6012. Puncturing the anviltrocar 6010 through the double staple line 6004 at a point off thestaple overlap portion 6012 could lead to an anastomotic failure. Usingthe anvil trocar 6010 centering tool 6030 described in FIG. 109, thesurgeon can align the anvil trocar 6010 with the staple overlap portion6012 using the images displayed by the centering tool 6030. For example,in one implementation, the sensor 6022 is an inductive sensor. Since thestaple overlap portion 6012 contains more metal than the rest of thelateral portions of the double staple line 6004, the signal 6024 ismaximum when the sensor 6022 is aligned with and proximate to the stapleoverlap portion 6012. The sensor 6022 provides a signal to the surgicalhub 206 that indicates the location of the anvil trocar 6010 relative tothe staple overlap portion 6012. The output signal is converted to avisualization of the location of the anvil trocar 6010 relative to thestaple overlap portion 6012 that is displayed on the surgical hubdisplay 215.

As shown in FIG. 108, the anvil trocar 6010 is aligned with the stapleoverlap portion 6012 at the center of the double staple line 6004created by a double-stapling technique. The surgeon can now puncture theanvil trocar 6010 through the staple overlap portion 6012 of the doublestaple line 6004 and/or fully clamp on the tissue before firing thecircular stapler 6002 to cut out the staple overlap portion 6012 andform an anastomosis.

FIG. 109 illustrates a centering tool 6030 displayed on a surgical hubdisplay 215, the centering tool providing a display of a staple overlapportion 6012 of a double staple line 6004 created by a double-stalingtechnique, where the anvil trocar 6010 is not aligned with the stapleoverlap portion 6012 of the double staple line 6004 as shown in FIG.107. The centering tool 6030 presents an image 6038 on the surgical hubdisplay 215 of the double staple line 6004 and an image 6040 of thestaple overlap portion 6012 received from the laparoscope 6014. A targetalignment ring 6032 centered about the image 6040 of the staple overlapportion 6012 circumscribes the image 6038 of the double staple line 6004to ensure that the staple overlap portion 6012 is located within thecircumference of the projected cut path 6034 of the circular stapler6002 knife when the projected cut path 6034 is aligned to the targetalignment ring 6032. The crosshair 6036 (X) represents the location ofthe anvil trocar 6010 relative to the staple overlap portion 6012. Thecrosshair 6036 (X) indicates the point through the double staple line6004 where the anvil trocar 6010 would puncture if it were advanced fromits current location.

As shown in FIG. 109, the anvil trocar 6010 is not aligned with thedesired puncture through location designated by the image 6040 of thestaple overlap portion 6012. To align the anvil trocar 6010 with thestaple overlap portion 6012 the surgeon manipulates the circular stapler6002 until the projected cut path 6034 overlaps the target alignmentring 6032 and the crosshair 6036 (X) is centered on the image 6040 ofthe staple overlap portion 6012. Once alignment is complete, the surgeonpunctures the anvil trocar 6010 through the staple overlap portion 6012of the double staple line 6004 and/or fully clamps on the tissue beforefiring the circular stapler 6002 to cut out the staple overlap portion6012 and form the anastomosis.

As discussed above, the sensor 6022 is configured to detect the positionof the anvil trocar 6010 relative to the staple overlap portion 6012.Accordingly, the location of the crosshair 6036 (X) presented on thesurgical hub display 215 is determined by the surgical stapler sensor6022. In another aspect, the sensor 6022 may be located on thelaparoscope 6014, where the sensor 6022 is configured to detect the tipof the anvil trocar 6010. In other aspects, the sensor 6022 may belocated either on the circular stapler 6022 or the laparoscope 6014, orboth, to determine the location of the anvil trocar 6010 relative to thestaple overlap portion 6012 and provide the information to the surgicalhub display 215 via the surgical hub 206.

FIGS. 110 and 111 illustrate a before image 6042 and an after image 6043of a centering tool 6030, according to one aspect of the presentdisclosure. FIG. 110 illustrates an image of a projected cut path 6034of an anvil trocar 6010 and circular knife before alignment with thetarget alignment ring 6032 circumscribing the image 6038 of the doublestaple line 6004 over the image 6040 of the staple overlap portion 6040presented on a surgical hub display 215. FIG. 111 illustrates an imageof a projected cut path 6034 of an anvil trocar 6010 and circular knifeafter alignment with the target alignment ring 6032 circumscribing theimage 6038 of the double staple line 6004 over the image 6040 of thestaple overlap portion 6040 presented on a surgical hub display 215. Thecurrent location of the anvil trocar 6010 is marked by the crosshair6036 (X), which as shown in FIG. 110, is positioned below and to theleft of center of the image 6040 of the staple overlap portion 6040. Asshown in FIG. 111, as the surgeon moves the anvil trocar 6010 of thealong the projected path 6046, the projected cut path 6034 aligns withthe target alignment ring 6032. The target alignment ring 6032 may bedisplayed as a greyed out alignment circle overlaid over the currentposition of the anvil trocar 6010 relative to the center of the doublestaple line 6004, for example. The image may include indication marks toassist the alignment process by indication which direction to move theanvil trocar 6010. The target alignment ring 6032 may be shown in bold,change color or may be highlighted when it is located within apredetermined distance of center within acceptable limits.

In another aspect, the sensor 6022 may be configured to detect thebeginning and end of a linear staple line in a colorectal transectionand to provide the position of the current location of the anvil trocar6010 of the circular stapler 6002. In another aspect, the presentdisclosure provides a surgical hub display 215 to present the circularstapler 6002 centered on the linear staple line, which would create evendog ears, and to provide the current position of the anvil trocar 6010to allow the surgeon to center or align the anvil trocar 6010 as desiredbefore puncturing and/or fully clamping on tissue prior to firing thecircular stapler 6002.

In another aspect, as described in FIGS. 112-114 and with reference alsoto FIGS. 1-11 to show interaction with an interactive surgical system100 environment including a surgical hub 106, 206, in alaparoscopic-assisted rectal surgery colorectal transection using alinear stapling technique, the beginning and end of the linear stapleline 6052 is detected and the current location of the anvil trocar 6010of the circular stapler 6002 is displayed on a surgical hub display 215coupled to the surgical hub 206. The surgical hub display 215 displays acircular image centered on the double staple line 6004, which wouldcreate even dog ears and the current position of the anvil trocar 6002is displayed to allow the surgeon to center or align the anvil trocar6010 before puncturing through the linear staple line 6052 and/or fullyclamping on the tissue before firing the circular stapler 6002 to cutout the center 6050 of the linear staple line 6052 to form ananastomosis.

FIGS. 112-114 illustrate a process of aligning an anvil trocar 6010 of acircular stapler 6022 to a center 6050 of a linear staple line 6052created by a linear stapling technique, according to one aspect of thepresent disclosure. FIGS. 112 and 113 illustrate a laparoscope 6014 anda sensor 6022 located on the circular stapler 6022 to determine thelocation of the anvil trocar 6010 relative to the center 6050 of thelinear staple line 6052. The anvil trocar 6010 and the sensor 6022 isinserted into the colon 6020 below the linear staple line 6052 and thelaparoscope 6014 is inserted through the abdomen above the linear stapleline 6052.

FIG. 112 illustrates the anvil trocar 6010 out of alignment with thecenter 6050 of the linear staple line 6052 and FIG. 113 illustrates theanvil trocar 6010 in alignment with the center 6050 of the linear stapleline 6052. The sensor 6022 is used to detect the center 6050 of thelinear staple line 6052 to align the anvil trocar 6010 with the centerof the staple line 6052. In one aspect, the center 6050 of the linearstaple line 6052 may be located by moving the circular stapler 6002until one end of the linear staple line 6052 is detected. An end may bedetected when there are no more staples in the path of the sensor 6022.Once one of the ends is reached, the circular stapler 6002 is movedalong the linear staple line 6053 until the opposite end is detected andthe length “1” of the linear staple line 6052 is determined bymeasurement or by counting individual staples by the sensor 6022. Oncethe length of the linear staple line 6052 is determined, the center 6050of the linear staple line 6052 can be determined by dividing the lengthby two “½.”

FIG. 114 illustrates a centering tool 6054 displayed on a surgical hubdisplay 215, the centering tool providing a display of a linear stapleline 6052, where the anvil trocar 6010 is not aligned with the stapleoverlap portion 6012 of the double staple line 6004 as shown in FIG.112. The surgical hub display 215 presents a standard reticle field ofview 6056 of the laparoscopic field of view 6016 of the linear stapleline 6052 and a portion of the colon 6020. The surgical hub display 215also presents a target ring 6062 circumscribing the image center of thelinear staple line and a projected cut path 6064 of the anvil trocar andcircular knife. The crosshair 6066 (X) represents the location of theanvil trocar 6010 relative to the center 6050 of the linear staple line6052. The crosshair 6036 (X) indicates the point through the linearstaple line 6052 where the anvil trocar 6010 would puncture if it wereadvanced from its current location.

As shown in FIG. 114, the anvil trocar 6010 is not aligned with thedesired puncture through location designated by the offset between thetarget ring 6062 and the projected cut path 6064. To align the anviltrocar 6010 with the center 6050 of the linear staple line 6052 thesurgeon manipulates the circular stapler 6002 until the projected cutpath 6064 overlaps the target alignment ring 6062 and the crosshair 6066(X) is centered on the image 6040 of the staple overlap portion 6012.Once alignment is complete, the surgeon punctures the anvil trocar 6010through the center 6050 of the linear staple line 6052 and/or fullyclamps on the tissue before firing the circular stapler 6002 to cut outthe staple overlap portion 6012 and forming the anastomosis.

In one aspect, the present disclosure provides an apparatus and methodfor displaying an image of an linear staple line 6052 using a lineartransection technique and an alignment ring or bullseye positioned as ifthe anvil trocar 6010 of the circular stapler 6022 were centeredappropriately along the linear staple line 6052. The apparatus displaysa greyed out alignment ring overlaid over the current position of theanvil trocar 6010 relative to the center 6050 of the linear staple line6052. The image may include indication marks to assist the alignmentprocess by indication which direction to move the anvil trocar 6010. Thealignment ring may be bold, change color or highlight when it is locatedwithin a predetermined distance of centered.

With reference now to FIGS. 112-115, FIG. 115 is an image 6080 of astandard reticle field view 6080 of a linear staple line 6052transection of a surgical as viewed through a laparoscope 6014 displayedon the surgical hub display 215, according to one aspect of the presentdisclosure. In a standard reticle view 6080, it is difficult to see thelinear staple line 6052 in the standard reticle field of view 6056.Further, there are no alignment aids to assist with alignment andintroduction of the anvil trocar 6010 to the center 6050 of the linearstaple line. This view does not show an alignment circle or alignmentmark to indicate if the circular stapler is centered appropriately anddoes not show the projected trocar path. In this view it also difficultto see the staples because there is no contrast with the backgroundimage.

With reference now to FIGS. 112-116, FIG. 116 is an image 6082 of alaser-assisted reticle field of view 6072 of the surgical site shown inFIG. 115 before the anvil trocar 6010 and circular knife of the circularstapler 6002 are aligned to the center 6050 of the linear staple line6052, according to one aspect of the present disclosure. Thelaser-assisted reticle field of view 6072 provides an alignment mark orcrosshair 6066 (X), currently positioned below and to the left of centerof the linear staple line 6052 showing the projected path of the anviltrocar 6010 to assist positioning of the anvil trocar 6010. In additionto the projected path marked by the crosshair 6066 (X) of the anviltrocar 6010, the image 6082 displays the staples of the linear stapleline 6052 in a contrast color to make them more visible against thebackground. The linear staple line 6052 is highlighted and a bullseyetarget 6070 is displayed over the center 6050 of the linear staple line6052. Outside of the laser-assisted reticle field of view 6072, theimage 6082 displays a status warning box 6068, a suggestion box 6074, atarget ring 6062, and the current alignment position of the anvil trocar6010 marked by the crosshair 6066 (X) relative to the center 6050 of thelinear staple line 6052. As shown in FIG. 116, the status warning box6068 indicates that the trocar is “MISALIGNED” and the suggestion box6074 states “Adjust trocar to center staple line.”

With reference now to FIGS. 112-117, FIG. 117 is an image 6084 of alaser-assisted reticle field of view 6072 of the surgical site shown inFIG. 116 after the anvil trocar 6010 and circular knife of the circularstapler 6002 are aligned to the center 6050 of the linear staple line6052, according to one aspect of the present disclosure. Thelaser-assisted reticle field of view 6072 provides an alignment mark orcrosshair 6066 (X), currently positioned below and to the left of centerof the linear staple line 6052 showing the projected path of the anviltrocar 6010 to assist positioning of the anvil trocar 6010. In additionto the projected path marked by the crosshair 6066 (X) of the anviltrocar 6010, the image 6082 displays the staples of the linear stapleline 6052 in a contrast color to make them more visible against thebackground. The linear staple line 6052 is highlighted and a bullseyetarget 6070 is displayed over the center 6050 of the linear staple line6052. Outside of the laser-assisted reticle field of view 6072, theimage 6082 displays a status warning box 6068, a suggestion box 6074, atarget ring 6062, and the current alignment position of the anvil trocar6010 marked by the crosshair 6066 (X) relative to the center 6050 of thelinear staple line 6052. As shown in FIG. 116, the status warning box6068 indicates that the trocar is “MISALIGNED” and the suggestion box6074 states “Adjust trocar to center staple line.”

FIG. 117 is a laser assisted view of the surgical site shown in FIG. 116after the anvil trocar 6010 and circular knife are aligned to the centerof the staple line 6052. In this view, inside the field of view 6072 ofthe laser-assisted reticle, the alignment mark crosshair 6066 (X) ispositioned over the center of the staple line 6052 and the highlightedbullseye target to indicate alignment of the trocar to the center of thestaple line. Outside the field of view 6072 of the laser-assistedreticle, the status warning box indicates that the trocar is “ALIGNED”and the suggestion is “Proceed trocar introduction.”

FIG. 118 illustrates a non-contact inductive sensor 6090 implementationof the non-contact sensor 6022 to determine an anvil trocar 6010location relative to the center of a staple line transection (the stapleoverlap portion 6012 of the double staple line 6004 shown in FIGS.107-108 or the center 6050 of the linear staple line 6052 shown in FIGS.112-113, for example), according to one aspect of the presentdisclosure. The non-contact inductive sensor 6090 includes an oscillator6092 that drives an inductive coil 6094 to generate an electromagneticfield 6096. As a metal target 6098, such as a metal staple, isintroduced into the electromagnetic field 6096, eddy currents 6100induced in the target 6098 oppose the electromagnetic field 6096 and thereluctance shifts and the amplitude of the oscillator voltage 6102drops. An amplifier 6104 amplifies the oscillator voltage 6102 amplitudeas it changes.

With reference now to FIGS. 1-11 to show interaction with an interactivesurgical system 100 environment including a surgical hub 106, 206 andalso to FIGS. 106-117, the inductive sensor 6090 is a non-contactelectronic sensor. It can be used for positioning and detecting metalobjects such as the metal staples in the staple lines 6003, 6004, 6052described above. The sensing range of the inductive sensor 6090 isdependent on the type of metal being detected. Because the inductivesensor 6090 is a non-contact sensor, it can detect metal objects acrossa stapled tissue barrier. The inductive sensor 6090 can be locatedeither on the circular stapler 6002 to detect staples in the staplelines 6003, 6004, 6052, detect the location of the distal end of thelaparoscope 6014, or it may be located on the laparoscope 6014 to detectthe location of the anvil trocar 6010. A processor or control circuitlocated either in the circular stapler 6002, laparoscope 6014, orcoupled to the surgical hub 206 receives signals from the inductivesensors 6090 and can be employed to display the centering tool on thesurgical hub display 215 to determine the location of the anvil trocar6010 relative to either staple overlap portion 6012 of a double stapleline 6004 or the center 6050 of a linear staple line 6052.

In one aspect, the distal end of the laparoscope 6014 may be detected bythe inductive sensor 6090 located on the circular stapler 6002. Theinductive sensor 6090 may detect a metal target 6098 positioned on thedistal end of the laparoscope 6014. Once the laparoscope 6014 is alignedwith the center 6050 of the linear staple line 6052 or the stapleoverlap portion 6012 of the double staple line 6004, a signal from theinductive sensor 6090 is transmitted to circuits that convert thesignals from the inductive sensor 6090 to present an image of therelative alignment of the laparoscope 6014 with the anvil trocar 6010 ofthe circular stapler 6002.

FIGS. 119A and 119B illustrate one aspect of a non-contact capacitivesensor 6110 implementation of the non-contact sensor 6022 to determinean anvil trocar 6010 location relative to the center of a staple linetransection (the staple overlap portion 6012 of the double staple line6004 shown in FIGS. 107-108 or the center 6050 of the linear staple line6052 shown in FIGS. 112-113, for example), according to one aspect ofthe present disclosure. FIG. 119A shows the non-contact capacitivesensor 6110 without a nearby metal target and FIG. 119B shows thenon-contact capacitive sensor 6110 near a metal target 6112. Thenon-contact capacitive sensor 6110 includes capacitor plates 6114, 6116housed in a sensing head and establishes field lines 6118 when energizedby an oscillator waveform to define a sensing zone. FIG. 119A shows thefield lines 6118 when no target is present proximal to the capacitorplates 6114, 6116. FIG. 119B shows a ferrous or nonferrous metal target6120 in the sensing zone. As the metal target 6120 enters the sensingzone, the capacitance increases causing the natural frequency to shifttowards the oscillation frequency causing amplitude gain. Because thecapacitive sensor 6110 is a non-contact sensor, it can detect metalobjects across a stapled tissue barrier. The capacitive sensor 6110 canbe located either on the circular stapler 6002 to detect the staplelines 6004, 6052 or the location of the distal end of the laparoscope6014 or the capacitive sensor 6110 may be located on the laparoscope6014 to detect the location of the anvil trocar 6010. A processor orcontrol circuit located either in the circular stapler 6002, thelaparoscope 6014, or coupled to the surgical hub 206 receives signalsfrom the capacitive sensor 6110 to present an image of the relativealignment of the laparoscope 6014 with the anvil trocar 6010 of thecircular stapler 6002.

FIG. 120 is a logic flow diagram 6130 of a process depicting a controlprogram or a logic configuration for aligning a surgical instrument,according to one aspect of the present disclosure. With reference toFIGS. 1-11 to show interaction with an interactive surgical system 100environment including a surgical hub 106, 206 and also to FIGS. 106-119,the surgical hub 206 comprises a processor 244 and a memory 249 coupledto the processor 244. The memory 249 stores instructions executable bythe processor 244 to receive 6132 image data from a laparoscope imagesensor, generate 6134 a first image based on the image data, display6136 the first image on a surgical hub display 215 coupled to theprocessor 244, receive 6138 a signal from a non-contact sensor 6022, thesignal indicative of a position of a surgical device, generate a secondimage based on the signal indicative of the position of the surgicaldevice, e.g., the anvil trocar 6010 and display 6140 the second image onthe surgical hub display 215. The first image data represents a center6044, 6050 of a staple line 6004, 6052 seal. The first image representsa target corresponding to the center 6044, 6050 of the staple line 6004,6052 seal. The signal is indicative of a position of a surgical device,e.g., an anvil trocar 6010, relative to the center 6044, 6050 of thestaple line 6004, 6052 seal. The second image represents the position ofthe surgical device, e.g., an anvil trocar 6010, along a projected path6018 of the surgical device, e.g., an anvil trocar 6010, toward thecenter 6044, 6050 of the staple line 6004, 6052 seal.

In one aspect, the center 6044 of the double staple line 6004 sealdefines a staple overlap portion 6012. In another aspect, an imagesensor receives an image from a medical imaging device. In anotheraspect, the surgical device is a circular stapler 6002 comprising ananvil trocar 6010 and the non-contact sensor 6022 is configured todetect the location of the anvil trocar 6010 relative to the center 6044of the double staple line 6004 seal. In another aspect, the non-contactsensor 6022 is an inductive sensor 6090. In another aspect, thenon-contact sensor 6022 is a capacitive sensor 6110. In one aspect, thestaple line may be a linear staple line 6052 formed using a lineartransection technique.

Cooperation Between Local Instrument Displays and Paired Imaging DeviceDisplay

In one aspect, the present disclosure provides an instrument including alocal display, a hub having an operating room (OR), or operatingtheater, display separate from the instrument display. When theinstrument is linked to the surgical hub, the secondary display on thedevice reconfigures to display different information than when it isindependent of the surgical hub connection. In another aspect, someportion of the information on the secondary display of the instrument isthen displayed on the primary display of the surgical hub. In anotheraspect, image fusion allowing the overlay of the status of a device, theintegration landmarks being used to interlock several images and atleast one guidance feature are provided on the surgical hub and/orinstrument display. Techniques for overlaying or augmenting imagesand/or text from multiple image/text sources to present composite imageson a single display are described hereinbelow in connection with FIGS.129-137 and FIGS. 147-151.

In another aspect, the present disclosure provides cooperation betweenlocal instrument displays and a paired laparoscope display. In oneaspect, the behavior of a local display of an instrument changes when itsenses the connectable presence of a global display coupled to thesurgical hub. In another aspect, the present disclosure provides 360°composite top visual field of view of a surgical site to avoidcollateral structures. Each of these techniques is describedhereinbelow.

During a surgical procedure, the surgical site is displayed on a remote“primary” surgical hub display. During a surgical procedure, surgicaldevices track and record surgical data and variables (e.g., surgicalparameters) that are stored in the instrument (see FIGS. 12-19 forinstrument architectures comprising processors, memory, controlcircuits, storage, etc.). The surgical parameters include force-to-fire(FTF), force-to-close (FTC), firing progress, tissue gap, power level,impedance, tissue compression stability (creep), and the like. Usingconventional techniques during the procedure the surgeon needs to watchtwo separate displays. Providing image/text overlay is thus advantageousbecause during the procedure the surgeon can watch a single displaypresenting the overlaid image/text information.

One solution detects when the surgical device (e.g., instrument) isconnected to the surgical hub and then display a composite image on theprimary display that includes a field of view of the surgical sitereceived from a first instrument (e.g., medical imaging device such as,e.g., laparoscope, endoscope, thoracoscope, and the like) augmented bysurgical data and variables received from a second instrument (e.g., asurgical stapler) to provide pertinent images and data on the primarydisplay.

During a surgical procedure the surgical site is displayed as a narrowfield of view of a medical imaging device on the primary surgical hubdisplay. Items outside the current field of view, collateral structures,cannot be viewed without moving the medical imaging device.

One solution provides a narrow field of view of the surgical site in afirst window of the display augmented by a wide field of view of thesurgical site in a separate window of the display. This provides acomposite over head field of view mapped using two or more imagingarrays to provide an augmented image of multiple perspective views ofthe surgical site.

In one aspect, the present disclosure provides a surgical hub,comprising a processor and a memory coupled to the processor. The memorystores instructions executable by the processor to detect a surgicaldevice connection to the surgical hub, transmit a control signal to thedetected surgical device to transmit to the surgical hub surgicalparameter data associated with the detected device, receive the surgicalparameter data, receive image data from an image sensor, and display, ona display coupled to the surgical hub, an image received from the imagesensor in conjunction with the surgical parameter data received from thesurgical device.

In another aspect, the present disclosure provides a surgical hub,comprising a processor and a memory coupled to the processor. The memorystores instructions executable by the processor to receive first imagedata from a first image sensor, receive second image data from a secondimage sensor, and display, on a display coupled to the surgical hub, afirst image corresponding to the first field of view and a second imagecorresponding to the second field of view. The first image datarepresents a first field of view and the second image data represents asecond field of view.

In one aspect, the first field of view is a narrow angle field of viewand the second field of view is a wide angle field of view. In anotheraspect, the memory stores instructions executable by the processor toaugment the first image with the second image on the display. In anotheraspect, the memory stores instructions executable by the processor tofuse the first image and the second image into a third image and displaya fused image on the display. In another aspect, the fused image datacomprises status information associated with a surgical device, an imagedata integration landmark to interlock a plurality of images, and atleast one guidance parameter. In another aspect, the first image sensoris the same as the same image sensor and wherein the first image data iscaptured as a first time and the second image data is captured at asecond time.

In another aspect, the memory stores instructions executable by theprocessor to receive third image data from a third image sensor, whereinthe third image data represents a third field of view, generatecomposite image data comprising the second and third image data, displaythe first image in a first window of the display, wherein the firstimage corresponds to the first image data, and display a third image ina second window of the display, wherein the third image corresponds tothe composite image data.

In another aspect, the memory stores instructions executable by theprocessor to receive third image data from a third image sensor, whereinthe third image data represents a third field of view, fuse the secondand third image data to generate fused image data, display the firstimage in a first window of the display, wherein the first imagecorresponds to the first image data, and display a third image in asecond window of the display, wherein the third image corresponds to thefused image data.

In various aspects, the present disclosure provides a control circuit toperform the functions described above. In various aspects, the presentdisclosure provides a non-transitory computer readable medium storingcomputer readable instructions, which when executed, causes a machine toperform the functions described above.

By displaying endoscope images augmented with surgical device images onone primary surgical hub display, enables the surgeon to focus on onedisplay to obtain a field of view of the surgical site augmented withsurgical device data associated with the surgical procedure such asforce-to-fire, force-to-close, firing progress, tissue gap, power level,impedance, tissue compression stability (creep), and the like.

Displaying a narrow field of view image in a first window of a displayand a composite image of several other perspectives such as wider fieldsof view enables the surgeon to view a magnified image of the surgicalsite simultaneously with wider fields of view of the surgical sitewithout moving the scope.

In one aspect, the present disclosure provides both global and localdisplay of a device, e.g., a surgical instrument, coupled to thesurgical hub. The device displays all of its relevant menus and displayson a local display until it senses a connection to the surgical hub atwhich point a sub-set of the information is displayed only on themonitor through the surgical hub and that information is either mirroredon the device display or is no longer accessible on the device detonatedscreen. This technique frees up the device display to show differentinformation or display larger font information on the surgical hubdisplay.

In one aspect, the present disclosure provides an instrument having alocal display, a surgical hub having an operating theater (e.g.,operating room or OR) display that is separate from the instrumentdisplay. When the instrument is linked to the surgical hub, theinstrument local display becomes a secondary display and the instrumentreconfigures to display different information than when it is operatingindependent of the surgical hub connection. In another aspect, someportion of the information on the secondary display is then displayed onthe primary display in the operating theater through the surgical hub.

FIG. 121 illustrates a primary display 6200 of the surgical hub 206comprising a global display 6202 and a local instrument display 6204,according to one aspect of the present disclosure. With continuedreference to FIGS. 1-11 to show interaction with an interactive surgicalsystem 100 environment including a surgical hub 106, 206 and FIGS. 12-21for surgical hub connected instruments together with FIG. 121, the localinstrument display 6204 behavior is displayed when the instrument 235senses the connectable presence of a global display 6202 through thesurgical hub 206. The global display 6202 shows a field of view 6206 ofa surgical site 6208, as viewed through a medical imaging device suchas, for example, a laparoscope/endoscope 219 coupled to an imagingmodule 238, at the center of the surgical hub display 215, referred toherein also as a monitor, for example. The end effector 6218 portion ofthe connected instrument 235 is shown in the field of view 6206 of thesurgical site 6208 in the global display 6202. The images shown on thedisplay 237 located on an instrument 235 coupled to the surgical hub 206is shown, or mirrored, on the local instrument display 6204 located inthe lower right corner of the monitor 6200 as shown in FIG. 121, forexample. During operation, all relevant instrument and information andmenus are displayed on the display 237 located on the instrument 235until the instrument 235 senses a connection of the instrument 235 tothe surgical hub 206 at which point all or some sub-set of theinformation presented on the instrument display 237 is displayed only onthe local instrument display 6204 portion of the surgical hub display6200 through the surgical hub 206. The information displayed on thelocal instrument display 6204 may be mirrored on the display 237 locatedon the instrument 235 or may be no longer accessible on the instrumentdisplay 237 detonated screen. This technique frees up the instrument 235to show different information or to show larger font information on thesurgical hub display 6200. Several techniques for overlaying oraugmenting images and/or text from multiple image/text sources topresent composite images on a single display are described hereinbelowin connection with FIGS. 129-137 and FIGS. 147-151.

The surgical hub display 6200 provides perioperative visualization ofthe surgical site 6208. Advanced imaging identifies and visuallyhighlights 6222 critical structures such as the ureter 6220 (or nerves,etc.) and also tracks instrument proximity displays 6210 and shown onthe left side of the display 6200. In the illustrated example, theinstrument proximity displays 6210 show instrument specific settings.For example the top instrument proximity display 6212 shows settings fora monopolar instrument, the middle instrument proximity display 6214shows settings for a bipolar instrument, and the bottom instrumentproximity display 6212 shows settings for an ultrasonic instrument.

In another aspect, independent secondary displays or dedicated localdisplays can be linked to the surgical hub 206 to provide both aninteraction portal via a touchscreen display and/or a secondary screenthat can display any number of surgical hub 206 tracked data feeds toprovide a clear non-confusing status. The secondary screen may displayforce to fire (FTF), tissue gap, power level, impedance, tissuecompression stability (creep), etc., while the primary screen maydisplay only key variables to keep the feed free of clutter. Theinteractive display may be used to move the display of specificinformation to the primary display to a desired location, size, color,etc. In the illustrated example, the secondary screen displays theinstrument proximity displays 6210 on the left side of the display 6200and the local instrument display 6204 on the bottom right side of thedisplay 6200. The local instrument display 6204 presented on thesurgical hub display 6200 displays an icon of the end effector 6218,such as the icon of a staple cartridge 6224 currently in use, the size6226 of the staple cartridge 6224 (e.g., 60 mm), and an icon of thecurrent position of the knife 6228 of the end effector.

In another aspect, the display 237 located on the instrument 235displays the wireless or wired attachment of the instrument 235 to thesurgical hub 206 and the instrument's communication/recording on thesurgical hub 206. A setting may be provided on the instrument 235 toenable the user to select mirroring or extending the display to bothmonitoring devices. The instrument controls may be used to interact withthe surgical hub display of the information being sourced on theinstrument. As previously discussed, the instrument 235 may comprisewireless communication circuits to communicate wirelessly with thesurgical hub 206.

In another aspect, a first instrument coupled to the surgical hub 206can pair to a screen of a second instrument coupled to the surgical hub206 allowing both instruments to display some hybrid combination ofinformation from the two devices of both becoming mirrors of portions ofthe primary display. In yet another aspect, the primary display 6200 ofthe surgical hub 206 provides a 360° composite top visual view of thesurgical site 6208 to avoid collateral structures. For example, asecondary display of the end-effector surgical stapler may be providedwithin the primary display 6200 of the surgical hub 206 or on anotherdisplay in order to provide better perspective around the areas within acurrent the field of view 6206. These aspects are described hereinbelowin connection with FIGS. 122-124.

FIGS. 122-124 illustrate a composite overhead views of an end-effector6234 portion of a surgical stapler mapped using two or more imagingarrays or one array and time to provide multiple perspective views ofthe end-effector 6234 to enable the composite imaging of an overheadfield of view. The techniques described herein may be applied toultrasonic instruments, electrosurgical instruments, combinationultrasonic/electrosurgical instruments, and/or combination surgicalstapler/electrosurgical instruments. Several techniques for overlayingor augmenting images and/or text from multiple image/text sources topresent composite images on a single display are described hereinbelowin connection with FIGS. 129-137 and FIGS. 147-151.

FIG. 122 illustrates a primary display 6200 of the surgical hub 206,according to one aspect of the present disclosure. A primary window 6230is located at the center of the screen shows a magnified or explodednarrow angle view of a surgical field of view 6232. The primary window6230 located in the center of the screen shows a magnified or narrowangle view of an end-effector 6234 of the surgical stapler grasping avessel 6236. The primary window 6230 displays knitted images to producea composite image that enables visualization of structures adjacent tothe surgical field of view 6232. A second window 6240 is shown in thelower left corner of the primary display 6200. The second window 6240displays a knitted image in a wide angle view at standard focus of theimage shown in the primary window 6230 in an overhead view. The overheadview provided in the second window 6240 enables the viewer to easily seeitems that are out of the narrow field surgical field of view 6232without moving the laparoscope, or other imaging device 239 coupled tothe imaging module 238 of the surgical hub 206. A third window 6242 isshown in the lower right corner of the primary display 6200 shows anicon 6244 representative of the staple cartridge of the end-effector6234 (e.g., a staple cartridge in this instance) and additionalinformation such as “4 Row” indicating the number of staple rows 6246and “35 mm” indicating the distance 6248 traversed by the knife alongthe length of the staple cartridge. Below the third window 6242 isdisplayed an icon 6258 of a frame of the current state of a clampstabilization sequence 6250 (FIG. 123) that indicates clampstabilization.

FIG. 123 illustrates a clamp stabilization sequence 6250 over a fivesecond period, according to one aspect of the present disclosure. Theclamp stabilization sequence 6250 is shown over a five second periodwith intermittent displays 6252, 6254, 6256, 6258, 6260 spaced apart atone second intervals 6268 in addition to providing the real time 6266(e.g., 09:35:10), which may be a pseudo real time to preserve anonymityof the patient. The intermittent displays 6252, 6254, 6256, 6258, 6260show elapsed by filling in the circle until the clamp stabilizationperiod is complete. At that point, the last display 6260 is shown insolid color. Clamp stabilization after the end effector 6234 clamps thevessel 6236 enables the formation of a better seal.

FIG. 124 illustrates a diagram 6270 of four separate wide angle viewimages 6272, 6274, 6276, 6278 of a surgical site at four separate timesduring the procedure, according to one aspect of the present disclosure.The sequence of images shows the creation of an overhead composite imagein wide and narrow focus over time. A first image 6272 is a wide angleview of the end-effector 6234 clamping the vessel 6236 taken at anearlier time t₀ (e.g., 09:35:09). A second image 6274 is another wideangle view of the end-effector 6234 clamping the vessel 6236 taken atthe present time t₁ (e.g., 09:35:13). A third image 6276 is a compositeimage of an overhead view of the end-effector 6234 clamping the vessel6236 taken at present time t₁. The third image 6276 is displayed in thesecond window 6240 of the primary display 6200 of the surgical hub 206as shown in FIG. 122. A fourth image 6278 is a narrow angle view of theend-effector 6234 clamping the vessel 6236 at present time t₁ (e.g.,09:35:13). The fourth image 6278 is the narrow angle view of thesurgical site shown in the primary window 6230 of the primary display6200 of the surgical hub 206 as shown in FIG. 122.

Display of Instrument Specific Data Needed for Efficient Use of theEnd-Effector

In one aspect, the present disclosure provides a surgical hub display ofinstrument specific data needed for efficient use of a surgicalinstrument, such as a surgical stapler. The techniques described hereinmay be applied to ultrasonic instruments, electrosurgical instruments,combination ultrasonic/electrosurgical instruments, and/or combinationsurgical stapler/electrosurgical instruments. In one aspect, a clamptime indicator based on tissue properties is shown on the display. Inanother aspect, a 360° composite top visual view is shown on the displayto avoid collateral structures as shown and described in connection withFIGS. 121-124 is incorporated herein by reference and, for concisenessand clarity of disclosure, the description of FIGS. 121-124 will not berepeated here.

In one aspect, the present disclosure provides a display of tissue creepto provide the user with in-tissue compression/tissue stability data andto guide the user making an appropriate choice of when to conduct thenext instrument action. In one aspect, an algorithm calculates aconstant advancement of a progressive time based feedback system relatedto the viscoelastic response of tissue. These and other aspects aredescribed hereinbelow.

FIG. 125 is a graph 6280 of tissue creep clamp stabilization curves6282, 6284 for two tissue types, according to one aspect of the presentdisclosure. The clamp stabilization curves 6284, 6284 are plotted asforce-to-close (FTC) as a function of time, where FTC (N) is displayedalong the vertical axis and Time, t, (Sec) is displayed along thehorizontal axis. The FTC is the amount of force exerted to close theclamp arm on the tissue. The first clamp stabilization curve 6282represents stomach tissue and the second clamp stabilization curve 6284represents lung tissue. In one aspect, the FTC along the vertical axisis scaled from 0-180 N. and the horizontal axis is scaled from 0-5 Sec.As shown, the FTC as a different profile over a five second clampstabilization period (e.g., as shown in FIG. 123).

With reference to the first clamp stabilization curve 6282, as thestomach tissue is clamped by the end-effector 6234, the force-to-close(FTC) applied by the end-effector 6234 increases from 0 N to a peakforce-to-close of ˜180 N after ˜1 Sec. While the end-effector 6234remains clamped on the stomach tissue, the force-to-close decays andstabilizes to ˜150 N over time due to tissue creep.

Similarly, with reference to the second clamp stabilization curve 6284,as the lung tissue is clamped by the end-effector 6234, theforce-to-close applied by the end-effector 6234 increases from 0 N to apeak force-to-close of ˜90 N after just less than ˜1 Sec. While theend-effector 6234 remains clamped on the lung tissue, the force-to-closedecays and stabilizes to ˜60 N over time due to tissue creep.

The end-effector 6234 clamp stabilization is monitored as describedabove in connection with FIGS. 122-124 and is displayed every secondcorresponding the sampling times t₁, t₂, t₃, t₄, t₅ of theforce-to-close to provide user feedback regarding the state of theclamped tissue. FIG. 125 shows an example of monitoring tissuestabilization for the lung tissue by sampling the force-to-close everysecond over a 5 seconds period. At each sample time t₁, t₂, t₃, t₄, t₅,the instrument 235 or the surgical hub 206 calculates a correspondingvector tangent 6288, 6292, 6294, 6298, 6302 to the second clampstabilization curve 6284. The vector tangent 6288, 6292, 6294, 6298,6302 is monitored until its slope drops below a threshold to indicatethat the tissue creep is complete and the tissue is ready to sealed andcut. As shown in FIG. 125, the lung tissue is ready to be sealed and cutafter ˜5 Sec. clamp stabilization period, where a solid gray circle isshown at sample time 6300. As shown, the vector tangent 6302 is lessthan a predetermined threshold.

The equation of a vector tangent 6288, 6292, 6294, 6298, 6302 to theclamp stabilization curve 6284 may be calculated using differentialcalculus techniques, for example. In one aspect, at a given point on theclamp stabilization curve 6284, the gradient of the curve 6284 is equalto the gradient of the tangent to the curve 6284. The derivative (orgradient function) describes the gradient of the curve 6284 at any pointon the curve 6284. Similarly, it also describes the gradient of atangent to the curve 6284 at any point on the curve 6284. The normal tothe curve 6284 is a line perpendicular to the tangent to the curve 6284at any given point. To determine the equation of a tangent to a curvefind the derivative using the rules of differentiation. Substitute the xcoordinate (independent variable) of the given point into the derivativeto calculate the gradient of the tangent. Substitute the gradient of thetangent and the coordinates of the given point into an appropriate formof the straight line equation. Make the y coordinate (dependentvariable) the subject of the formula.

FIG. 126 is a graph 6310 of time dependent proportionate fill of a clampforce stabilization curve, according to one aspect of the presentdisclosure. The graph 6310 includes clamp stabilization curves 6312,6314, 6316 for standard thick stomach tissue, thin stomach tissue, andstandard lung tissue. The vertical axis represents FTC (N) scaled from0-240 N and the horizontal axis represents Time, t, (Sec) scaled from0-15 Sec. As shown, the standard thick stomach tissue curve 6316 is thedefault force decay stability curve. All three clamp stabilizationcurves 6312, 6314, 6316 FTC profiles reach a maximum force shortly afterclamping on the tissue and then the FTC decreases over time until iteventually stabilizes due to the viscoelastic response of the tissue. Asshown the standard lung tissue clamp stabilization curve 6312 stabilizesafter a period of ˜5 Sec., the thin stomach tissue clamp stabilizationcurve 6314 stabilizes after a period of ˜10 Sec., and the thick stomachtissue clamp stabilization curve 6316 stabilizes after a period of ˜15Sec.

FIG. 127 is a graph 6320 of the role of tissue creep in the clamp forcestabilization curve 6322, according to one aspect of the presentdisclosure. The vertical axis represents force-to-close FTC (N) and thehorizontal axis represents Time, t, (Sec) in seconds. Vector tangentangles dθ₁, dθ₂ . . . dθ_(n) are measured at each force-to-closesampling (t₀, t₁, t₂, t₃, t₄, etc.) times. The vector tangent angledθ_(n) is used to determine when the tissue has reached the creeptermination threshold, which indicates that the tissue has reached creepstability.

FIGS. 128A and 128B illustrate two graphs 6330, 6340 for determiningwhen the clamped tissue has reached creep stability, according to oneaspect of the present disclosure. The graph 6330 in FIG. 128Aillustrates a curve 6332 that represents a vector tangent angle dθ as afunction of time. The vector tangent angle dθ is calculated as discussedin FIG. 127. The horizontal line 6334 is the tissue creep terminationthreshold. The tissue creep is deemed to be stable at the intersection6336 of the vector tangent angle dθ curve 6332 and the tissue creeptermination threshold 6334. The graph 6340 in FIG. 128B illustrates aΔFTC curve 6342 that represents ΔFTC as a function of time. The ΔFTCcurve 6342 illustrates the threshold 6344 to 100% complete tissue creepstability meter. The tissue creep is deemed to be stable at theintersection 6346 of the ΔFTC curve 6342 and the threshold 6344.

Communication Techniques

With reference to FIGS. 1-11 to show interaction with an interactivesurgical system 100 environment including a surgical hub 106, 206, andin particular, FIGS. 9-10, in various aspects, the present disclosureprovides communications techniques for exchanging information between aninstrument 235, or other modules, and the surgical hub 206. In oneaspect, the communications techniques include image fusion to placeinstrument status and analysis over a laparoscope image, such as ascreen overlay of data, within and around the perimeter of an imagepresented on a surgical hub display 215, 217. In another aspect, thecommunication techniques include combining an intermediate short rangewireless, e.g., Bluetooth, signal with the image, and in another aspect,the communication techniques include applying security andidentification of requested pairing. In yet another aspect, thecommunication techniques include an independent interactive headset wornby a surgeon that links to the hub with audio and visual informationthat avoids the need for overlays, but allows customization of displayedinformation around periphery of view. Each of these communicationtechniques is discussed hereinbelow.

Screen Overlay of Data within and Around the Perimeter of the DisplayedImage

In one aspect, the present disclosure provides image fusion allowing theoverlay of the status of a device, the integration landmarks being usedto interlock several images, and at least one guidance feature. Inanother aspect, the present disclosure provides a technique for screenoverlay of data within and around the perimeter of displayed image.Radiographic integration may be employed for live internal sensing andpre-procedure overlay. Image fusion of one source may be superimposedover another. Image fusion may be employed to place instrument statusand analysis on a medical imaging device (e.g., laparoscope, endoscope,thoracoscope, etc.) image. Image fusion allows the overlay of the statusof a device or instrument, integration landmarks to interlock severalimages, and at least one guidance feature.

FIG. 129 illustrates an example of an augmented video image 6350comprising a pre-operative video image 6352 augmented with data 6354,6356, 6358 identifying displayed elements. An augmented reality visionsystem may be employed in surgical procedures to implement a method foraugmenting data onto a pre-operative image 6352. The method includesgenerating a pre-operative image 6352 of an anatomical section of apatient and generating an augmented video image of a surgical sitewithin the patient. The augmented video image 6350 includes an image ofat least a portion of a surgical tool 6354 operated by a user 6456. Themethod further includes processing the pre-operative image 6352 togenerate data about the anatomical section of the patient. The dataincludes a label 6358 for the anatomical section and a peripheral marginof at least a portion of the anatomical section. The peripheral marginis configured to guide a surgeon to a cutting location relative to theanatomical section, embedding the data and an identity of the user 6356within the pre-operative image 6350 to display an augmented video image6350 to the user about the anatomical section of the patient. The methodfurther includes sensing a loading condition on the surgical tool 6354,generating a feedback signal based on the sensed loading condition, andupdating, in real time, the data and a location of the identity of theuser operating the surgical tool 6354 embedded within the augmentedvideo image 6350 in response to a change in a location of the surgicaltool 6354 within the augmented video image 6350. Further examples aredisclosed in U.S. Pat. No. 9,123,155, titled APPARATUS AND METHOD FORUSING AUGMENTED REALITY VISION SYSTEM IN SURGICAL PROCEDURES, whichissued on Sep. 1, 2015, which is herein incorporated by reference in itsentirety.

In another aspect, radiographic integration techniques may be employedto overlay the pre-operative image 6352 with data obtained through liveinternal sensing or pre-procedure techniques. Radiographic integrationmay include marker and landmark identification using surgical landmarks,radiographic markers placed in or outside the patient, identification ofradio-opaque staples, clips or other tissue-fixated items. Digitalradiography techniques may be employed to generate digital images foroverlaying with a pre-operative image 6352. Digital radiography is aform of X-ray imaging that employs a digital image capture device withdigital X-ray sensors instead of traditional photographic film. Digitalradiography techniques provide immediate image preview and availabilityfor overlaying with the pre-operative image 6352. In addition, specialimage processing techniques can be applied to the digital X-ray mages toenhance the overall display quality of the image.

Digital radiography techniques employ image detectors that include flatpanel detectors (FPDs), which are classified in two main categoriesindirect FPDs and direct FPDs. Indirect FPDs include amorphous silicon(a-Si) combined with a scintillator in the detector's outer layer, whichis made from cesium iodide (CsI) or gadolinium oxy-sulfide (Gd2O2S),converts X-rays to light. The light is channeled through the a-Siphotodiode layer where it is converted to a digital output signal. Thedigital signal is then read out by thin film transistors (TFTs) orfiber-coupled charge coupled devices (CCDs). Direct FPDs includeamorphous selenium (a-Se) FPDs that convert X-ray photons directly intocharge. The outer layer of a flat panel in this design is typically ahigh-voltage bias electrode. X-ray photons create electron-hole pairs ina-Se, and the transit of these electrons and holes depends on thepotential of the bias voltage charge. As the holes are replaced withelectrons, the resultant charge pattern in the selenium layer is readout by a TFT array, active matrix array, electrometer probes or microplasma line addressing. Other direct digital detectors are based on CMOSand CCD technology. Phosphor detectors also may be employed to recordthe X-ray energy during exposure and is scanned by a laser diode toexcite the stored energy which is released and read out by a digitalimage capture array of a CCD.

FIG. 130 is a logic flow diagram 6360 of a process depicting a controlprogram or a logic configuration to display images, according to oneaspect of the present disclosure. With reference also to FIGS. 1-11 toshow interaction with an interactive surgical system 100 environmentincluding a surgical hub 106, 206, the present disclosure provides, inone aspect, a surgical hub 206, comprising a processor 244 and a memory249 coupled to the processor 244. The memory 249 stores instructionsexecutable by the processor 244 to receive 6362 first image data from afirst image sensor, receive 6364 second image data from a second imagesensor, and display 6366, on a display 217 coupled to the surgical hub206, a first image corresponding to the first field of view and a secondimage corresponding to the second field of view. The first image datarepresents a first field of view and the second image data represents asecond field of view.

In one aspect, the first field of view is a narrow angle field of viewand the second field of view is a wide angle field of view. In anotheraspect, the memory 249 stores instructions executable by the processor244 to augment the first image with the second image on the display. Inanother aspect, the memory 249 stores instructions executable by theprocessor 244 to fuse the first image and the second image into a thirdimage and display a fused image on the display 217. In another aspect,the fused image data comprises status information associated with asurgical device 235, an image data integration landmark to interlock aplurality of images, and at least one guidance parameter. In anotheraspect, the first image sensor is the same as the same image sensor andwherein the first image data is captured as a first time and the secondimage data is captured at a second time.

In another aspect, the memory 249 stores instructions executable by theprocessor 244 to receive third image data from a third image sensor,wherein the third image data represents a third field of view, generatecomposite image data comprising the second and third image data, displaythe first image in a first window of the display, wherein the firstimage corresponds to the first image data, and display a third image ina second window of the display 215, wherein the third image correspondsto the composite image data.

In another aspect, the memory 249 stores instructions executable by theprocessor 244 to receive third image data from a third image sensor,wherein the third image data represents a third field of view, fuse thesecond and third image data to generate fused image data, display thefirst image in a first window of the display 217, wherein the firstimage corresponds to the first image data, and display a third image ina second window of the display 217, wherein the third image correspondsto the fused image data.

Intermediate Short Range Wireless (e.g., Bluetooth) Signal Combiner

An intermediate short range wireless, e.g., Bluetooth, signal combinermay comprise a wireless heads-up display adapter placed into thecommunication path of the monitor to a laparoscope console allowing thesurgical hub to overlay data onto the screen. Security andidentification of requested pairing may augment the communicationtechniques.

FIG. 131 illustrates a communication system 6370 comprising anintermediate signal combiner 6372 positioned in the communication pathbetween an imaging module 238 and a surgical hub display 217, accordingto one aspect of the present disclosure. The signal combiner 6372receives image data from an imaging module 238 in the form of shortrange wireless or wired signals. The signal combiner 6372 also receivesaudio and image data form a headset 6374 and combines the image datafrom the imaging module 238 with the audio and image data from theheadset 6374. The surgical hub 206 receives the combined data from thecombiner 6372 and overlays the data provided to the display 217, wherethe overlaid data is displayed. The signal combiner 6372 may communicatewith the surgical hub 206 via wired or wireless signals. The headset6374 receives image data from an imaging device 6376 coupled to theheadset 6374 and receives audio data from an audio device 6378 coupledto the headset 6374. The imaging device 6376 may be a digital videocamera and the audio device 6378 may be a microphone. In one aspect, thesignal combiner 6372 may be an intermediate short range wireless, e.g.,Bluetooth, signal combiner. The signal combiner 6374 may comprise awireless heads-up display adapter to couple to the headset 6374 placedinto the communication path of the display 217 to a console allowing thesurgical hub 206 to overlay data onto the screen of the display 217.Security and identification of requested pairing may augment thecommunication techniques. The imaging module 238 may be coupled to avariety if imaging devices such as an endoscope 239, laparoscope, etc.,for example.

Independent Interactive Headset

FIG. 132 illustrates an independent interactive headset 6380 worn by asurgeon 6382 to communicate data to the surgical hub, according to oneaspect of the present disclosure. Peripheral information of theindependent interactive headset 6380 does not include active video.Rather, the peripheral information includes only device settings, orsignals that do not have same demands of refresh rates. Interaction mayaugment the surgeon's 6382 information based on linkage withpreoperative computerized tomography (CT) or other data linked in thesurgical hub 206. The independent interactive headset 6380 can identifystructure—ask whether instrument is touching a nerve, vessel, oradhesion, for example. The independent interactive headset 6380 mayinclude pre-operative scan data, an optical view, tissue interrogationproperties acquired throughout procedure, and/or processing in thesurgical hub 206 used to provide an answer. The surgeon 6382 can dictatenotes to the independent interactive headset 6380 to be saved withpatient data in the hub storage 248 for later use in report or in followup.

In one aspect, the independent interactive headset 6380 worn by thesurgeon 6382 links to the surgical hub 206 with audio and visualinformation to avoid the need for overlays, and allows customization ofdisplayed information around periphery of view. The independentinteractive headset 6380 provides signals from devices (e.g.,instruments), answers queries about device settings, or positionalinformation linked with video to identify quadrant or position. Theindependent interactive headset 6380 has audio control and audiofeedback from the headset 6380. The independent interactive headset 6380is still able to interact with all other systems in the operatingtheater (e.g., operating room), and have feedback and interactionavailable wherever the surgeon 6382 is viewing.

Identification and Usage Recording

In one aspect, the present disclosure provides a display of theauthenticity of reloads, modular components, or loading units. FIG. 133illustrates a method 6390 for controlling the usage of a device 6392. Adevice 6392 is connected to an energy source 6394. The device 6392includes a memory device 6396 that includes storage 6398 andcommunication 6400 devices. The storage 6398 includes data 6402 that maybe locked data 6404 or unlocked data 6406. Additionally, the storage6398 includes an error-detecting code 6408 such as a cyclic redundancycheck (CRC) value and a sterilization indicator 6410. The energy source6394 includes a reader 6412, display 6414, a processor 6416, and a dataport 6418 that couples the energy source 6394 to a network 6420. Thenetwork 6420 is coupled to a central server 6422, which is coupled to acentral database 6424. The network 6420 also is coupled to areprocessing facility 6426. The reprocessing facility 6426 includes areprocessing data reader/writer 6428 and a sterilizing device 6430.

The method comprises connecting the device to an energy source 6394.Data is read from a memory device 6396 incorporated in the device 6392.The data including one or more of a unique identifier (UID), a usagevalue, an activation value, a reprocessing value, or a sterilizationindicator. The usage value is incremented when the device 6392 isconnected to the energy source 6394. The activation value is incrementedwhen the device 6392 is activated permitting energy to flow from theenergy source 6394 to an energy consuming component of the device 6392.Usage of the device 6392 may be prevented if: the UID is on a list ofprohibited UIDs, the usage value is not lower than a usage limitationvalue, the reprocessing value is equal to a reprocessing limitationvalue, the activation value is equal to an activation limitation value,and/or the sterilization indicator does not indicate that the device hasbeen sterilized since its previous usage. Further examples are disclosedin U.S. Patent Application Publication No. 2015/0317899, titled SYSTEMAND METHOD FOR USING RFID TAGS TO DETERMINE STERILIZATION OF DEVICES,which published on Nov. 5, 2015, which is herein incorporated byreference in its entirety.

FIG. 134 provides a surgical system 6500 in accordance with the presentdisclosure and includes a surgical instrument 6502 that is incommunication with a console 6522 or a portable device 6526 through alocal area network 6518 or a cloud network 6520 via a wired or wirelessconnection. In various aspects, the console 6522 and the portable device6526 may be any suitable computing device. The surgical instrument 6502includes a handle 6504, an adapter 6508, and a loading unit 6514. Theadapter 6508 releasably couples to the handle 6504 and the loading unit6514 releasably couples to the adapter 6508 such that the adapter 6508transmits a force from a drive shaft to the loading unit 6514. Theadapter 6508 or the loading unit 6514 may include a force gauge (notexplicitly shown) disposed therein to measure a force exerted on theloading unit 6514. The loading unit 6514 includes an end effector 6530having a first jaw 6532 and a second jaw 6534. The loading unit 6514 maybe an in-situ loaded or multi-firing loading unit (MFLU) that allows aclinician to fire a plurality of fasteners multiple times withoutrequiring the loading unit 6514 to be removed from a surgical site toreload the loading unit 6514.

The first and second jaws 6532, 6534 are configured to clamp tissuetherebetween, fire fasteners through the clamped tissue, and sever theclamped tissue. The first jaw 6532 may be configured to fire at leastone fastener a plurality of times, or may be configured to include areplaceable multi-fire fastener cartridge including a plurality offasteners (e.g., staples, clips, etc.) that may be fired more that onetime prior to being replaced. The second jaw 6534 may include an anvilthat deforms or otherwise secures the fasteners about tissue as thefasteners are ejected from the multi-fire fastener cartridge.

The handle 6504 includes a motor that is coupled to the drive shaft toaffect rotation of the drive shaft. The handle 6504 includes a controlinterface to selectively activate the motor. The control interface mayinclude buttons, switches, levers, sliders, touchscreen, and any othersuitable input mechanisms or user interfaces, which can be engaged by aclinician to activate the motor.

The control interface of the handle 6504 is in communication with acontroller 6528 of the handle 6504 to selectively activate the motor toaffect rotation of the drive shafts. The controller 6528 is disposedwithin the handle 6504 and is configured to receive input from thecontrol interface and adapter data from the adapter 6508 or loading unitdata from the loading unit 6514. The controller 6528 analyzes the inputfrom the control interface and the data received from the adapter 6508and/or loading unit 6514 to selectively activate the motor. The handle6504 may also include a display that is viewable by a clinician duringuse of the handle 6504. The display is configured to display portions ofthe adapter or loading unit data before, during, or after firing of theinstrument 6502.

The adapter 6508 includes an adapter identification device 6510 disposedtherein and the loading unit 6514 includes a loading unit identificationdevice 6516 disposed therein. The adapter identification device 6510 isin communication with the controller 6528, and the loading unitidentification device 6516 is in communication with the controller 6528.It will be appreciated that the loading unit identification device 6516may be in communication with the adapter identification device 6510,which relays or passes communication from the loading unitidentification device 6516 to the controller 6528.

The adapter 6508 may also include a plurality of sensors 6512 (oneshown) disposed thereabout to detect various conditions of the adapter6508 or of the environment (e.g., if the adapter 6508 is connected to aloading unit, if the adapter 6508 is connected to a handle, if the driveshafts are rotating, the torque of the drive shafts, the strain of thedrive shafts, the temperature within the adapter 6508, a number offirings of the adapter 6508, a peak force of the adapter 6508 duringfiring, a total amount of force applied to the adapter 6508, a peakretraction force of the adapter 6508, a number of pauses of the adapter6508 during firing, etc.). The plurality of sensors 6512 provides aninput to the adapter identification device 6510 in the form of datasignals. The data signals of the plurality of sensors 6512 may be storedwithin, or be used to update the adapter data stored within, the adapteridentification device 6510. The data signals of the plurality of sensors6512 may be analog or digital. The plurality of sensors 6512 may includea force gauge to measure a force exerted on the loading unit 6514 duringfiring.

The handle 6504 and the adapter 6508 are configured to interconnect theadapter identification device 6510 and the loading unit identificationdevice 6516 with the controller 6528 via an electrical interface. Theelectrical interface may be a direct electrical interface (i.e., includeelectrical contacts that engage one another to transmit energy andsignals therebetween). Additionally or alternatively, the electricalinterface may be a non-contact electrical interface to wirelesslytransmit energy and signals therebetween (e.g., inductively transfer).It is also contemplated that the adapter identification device 6510 andthe controller 6528 may be in wireless communication with one anothervia a wireless connection separate from the electrical interface.

The handle 6504 includes a transmitter 6506 that is configured totransmit instrument data from the controller 6528 to other components ofthe system 6500 (e.g., the LAN 6518, the cloud 6520, the console 6522,or the portable device 6526). The transmitter 6506 also may receive data(e.g., cartridge data, loading unit data, or adapter data) from theother components of the system 6500. For example, the controller 6528may transmit instrument data including a serial number of an attachedadapter (e.g., adapter 6508) attached to the handle 6504, a serialnumber of a loading unit (e.g., loading unit 6514) attached to theadapter, and a serial number of a multi-fire fastener cartridge (e.g.,multi-fire fastener cartridge), loaded into the loading unit, to theconsole 6528. Thereafter, the console 6522 may transmit data (e.g.,cartridge data, loading unit data, or adapter data) associated with theattached cartridge, loading unit, and adapter, respectively, back to thecontroller 6528. The controller 6528 can display messages on the localinstrument display or transmit the message, via transmitter 6506, to theconsole 6522 or the portable device 6526 to display the message on thedisplay 6524 or portable device screen, respectively.

Multi-Functional Surgical Control System and Switching Interface forVerbal Control of Imaging Device

FIG. 135 illustrates a verbal AESOP camera positioning system. Furtherexamples are disclosed in U.S. Pat. No. 7,097,640, titledMULTI-FUNCTIONAL SURGICAL CONTROL SYSTEM AND SWITCHING INTERFACE, whichissued on Aug. 29, 2006, which is herein incorporated by reference inits entirety. FIG. 135 shows a surgical system 6550 that may be coupledto surgical hub 206, described in connection with FIGS. 1-11. The system6550 allows a surgeon to operate a number of different surgical devices6552, 6554, 6556, and 6558 from a single input device 6560. Providing asingle input device reduces the complexity of operating the variousdevices and improves the efficiency of a surgical procedure performed bya surgeon. The system 6550 may be adapted and configured to operate apositioning system for an imaging device such as a camera or endoscopeusing verbal commands.

The surgical device 6552 may be a robotic arm which can hold and move asurgical instrument. The arm 6552 may be a device such as that sold byComputer Motion, Inc. of Goleta, Calif. under the trademark AESOP, whichis an acronym for Automated Endoscopic System for Optimal Positioning.The arm 6552 is commonly used to hold and move an endoscope within apatient. The system 6550 allows the surgeon to control the operation ofthe robotic arm 6552 through the input device 6560.

The surgical device 6554 may be an electrocautery device. Electrocauterydevices typically have a bi-polar tip which carries a current that heatsand denatures tissue. The device is typically coupled to an on-offswitch to actuate the device and heat the tissue. The electrocauterydevice may also receive control signals to vary its power output. Thesystem 6550 allows the surgeon to control the operation of theelectrocautery device through the input device 6560.

The surgical device 6556 may be a laser. The laser 6556 may be actuatedthrough an on-off switch. Additionally, the power of the laser 6556 maybe controlled by control signals. The system 6550 allows the surgeon tocontrol the operation of the laser 6556 through the input device 6560.

The device 6558 may be an operating table. The operating table 6558 maycontain motors and mechanisms which adjust the position of the table.The present invention allows the surgeon to control the position of thetable 6558 through the input device 6560. Although four surgical devices6552, 6554, 6556, and 6558 are described, it is to be understood thatother functions within the operating room may be controlled through theinput device 6560. By way of example, the system 6560 may allow thesurgeon to control the lighting and temperature of the operating roomthrough the input device 6560.

The input device 6560 may be a foot pedal which has a plurality ofbuttons 6562, 6564, 6565, 6566, and 6568 that can be depressed by thesurgeon. Each button is typically associated with a specific controlcommand of a surgical device. For example, when the input device 6560 iscontrolling the robotic arm 6552, depressing the button 6562 may movethe arm in one direction and depressing the button 6566 may move the armin an opposite direction. Likewise, when the electrocautery device 6554or the laser 6556 is coupled to the input device 6560, depressing thebutton 6568 may energize the devices, and so forth and so on. Although afoot pedal is shown and described, it is to be understood that the inputdevice 6560 may be a hand controller, a speech interface which acceptsvoice commands from the surgeon, a cantilever pedal or other inputdevices which may be well known in the art of surgical device control.Using the speech interface, the surgeon is able to position a camera orendoscope connected to the robotic arm 6552 using verbal commands. Theimaging device, such as a camera or endoscope, may be coupled to therobotic arm 6552 positioning system that be controlled through thesystem 6550 using verbal commands.

The system 6550 has a switching interface 6570 which couples the inputdevice 6560 to the surgical devices 6552, 6554, 6556, and 6558. Theinterface 6570 has an input channel 6572 which is connected to the inputdevice 6560 by a bus 6574. The interface 6570 also has a plurality ofoutput channels 6576, 6578, 6580, and 6582 that are coupled to thesurgical devices by busses 6584, 6586, 6588, 6590, 6624, 6626, 6628 andwhich may have adapters or controllers disposed in electricalcommunication therewith and therebetween. Such adapters and controllerswill be discussed in more detail hereinbelow.

Because each device 6552, 6554, 6556, 6558 may require specificallyconfigured control signals for proper operation, adapters 6620, 6622 ora controller 6618 may be placed intermediate and in electricalcommunication with a specific output channel and a specific surgicaldevice. In the case of the robotic arm system 6552, no adapter isnecessary and as such, the robotic arm system 6552 may be in directconnection with a specific output channel. The interface 6570 couplesthe input channel 6572 to one of the output channels 6576, 6578, 6580,and 6582.

The interface 6570 has a select channel 6592 which can switch the inputchannel 6572 to a different output channel 6576, 6578, 6580, or 6582 sothat the input device 6560 can control any of the surgical devices. Theinterface 6570 may be a multiplexor circuit constructed as an integratedcircuit and placed on an ASIC. Alternatively, the interface 6570 may bea plurality of solenoid actuated relays coupled to the select channel bya logic circuit. The interface 6570 switches to a specific outputchannel in response to an input signal or switching signal applied onthe select channel 6592.

As depicted in FIG. 135, there may be several inputs to the selectchannel 6592. Such inputs originate from the foot pedal 6560, the speechinterface 6600 and the CPU 6662. The interface 6570 may have amultiplexing unit such that only one switching signal may be received atthe select channel 6592 at any one time, thus ensuring no substantialhardware conflicts. The prioritization of the input devices may beconfigured so the foot pedal has highest priority followed by the voiceinterface and the CPU. This is intended for example as theprioritization scheme may be employed to ensure the most efficientsystem. As such other prioritization schemes may be employed. The selectchannel 6592 may sequentially connect the input channel to one of theoutput channels each time a switching signal is provided to the selectchannel 6592. Alternatively, the select channel 6592 may be addressableso that the interface 6570 connects the input channel to a specificoutput channel when an address is provided to the select channel 6592.Such addressing is known in the art of electrical switches.

The select channel 6592 may be connected by line 6594 to a dedicatedbutton 6596 on the foot pedal 6560. The surgeon can switch surgicaldevices by depressing the button 6596. Alternatively, the select channel6592 may be coupled by line 6598 to a speech interface 6600 which allowsthe surgeon to switch surgical devices with voice commands.

The system 6550 may have a central processing unit (CPU) 6602 whichreceives input signals from the input device 6560 through the interface6570 and a bus 6585. The CPU 6602 receives the input signals, and canensure that no improper commands are being input at the controller. Ifthis occurs, the CPU 6602 may respond accordingly, either by sending adifferent switching signal to select channel 6592, or by alerting thesurgeon via a video monitor or speaker.

The CPU 6602 can also provide output commands for the select channel6592 on the bus 6608 and receives input commands from the speechinterface 6600 on the same bi-directional bus 6608. The CPU 6602 may becoupled to a monitor 6610 and/or a speaker 6612 by buses 6614 and 6616,respectively. The monitor 6610 may provide a visual indication of whichsurgical device is coupled to the input device 6560. The monitor mayalso provide a menu of commands which can be selected by the surgeoneither through the speech interface 6600 or button 6596. Alternatively,the surgeon could switch to a surgical device by selecting a commandthrough a graphic user interface. The monitor 6610 may also provideinformation regarding improper control signals sent to a specificsurgical device 6552, 6554, 6556, 6558 and recognized by the CPU 6602.Each device 6552, 6554, 6556, 6558 has a specific appropriate operatingrange, which is well known to the skilled artisan. As such, the CPU 6602may be programmed to recognize when the requested operation from theinput device 6560 is inappropriate and will then alert the surgeoneither visually via the monitor 6610 or audibly via the speaker 6612.The speaker 6612 may also provide an audio indication of which surgicaldevice is coupled to the input device 6560.

The system 6550 may include a controller 6618 which receives the inputsignals from the input device 6560 and provides corresponding outputsignals to control the operating table 6558. Likewise, the system mayhave adapters 6620, 6622 which provide an interface between the inputdevice 6560 and the specific surgical instruments connected to thesystem.

In operation, the interface 6570 initially couples the input device 6560to one of the surgical devices. The surgeon can control a differentsurgical device by generating an input command that is provided to theselect channel 6592. The input command switches the interface 6570 sothat the input device 6560 is coupled to a different output channel andcorresponding surgical device or adapter. What is thus provided is aninterface 6570 that allows a surgeon to select, operate and control aplurality of different surgical devices through a common input device6560.

FIG. 136 illustrates a multi-functional surgical control system 6650 andswitching interface for virtual operating room integration. A virtualcontrol system for controlling surgical equipment in an operating roomwhile a surgeon performs a surgical procedure on a patient, comprising:a virtual control device including an image of a control device locatedon a surface and a sensor for interrogating contact interaction of anobject with the image on the surface, the virtual control devicedelivering an interaction signal indicative of the contact interactionof the object with the image; and a system controller connected toreceive the interaction signal from the virtual control device and todeliver a control signal to the surgical equipment in response to theinteraction signal to control the surgical equipment in response to thecontact interaction of the object with the image. Further examples aredisclosed in U.S. Pat. No. 7,317,955, titled VIRTUAL OPERATING ROOMINTEGRATION, which issued on Jan. 8, 2008, which is herein incorporatedby reference in its entirety.

As shown in FIG. 136, communication links 6674 are established betweenthe system controller 6676 and the various components and functions ofthe virtual control system 6650. The communication links 6674 arepreferably optical paths, but the communication links may also be formedby radio frequency transmission and reception paths, hardwiredelectrical connections, or combinations of optical, radio frequency andhardwired connection paths as may be appropriate for the type ofcomponents and functions obtained by those components. The arrows at theends of the links 6674 represent the direction of primary informationflow.

The communication links 6674 with the surgical equipment 6652, a virtualcontrol panel 6556, a virtual foot switch 6654 and patient monitoringequipment 6660 are bidirectional, meaning that the information flows inboth directions through the links 6674 connecting those components andfunctions. For example, the system controller 6676 supplies signalswhich are used to create a control panel image from the virtual controlpanel 6656 and a foot switch image from the virtual foot switch 6654.The virtual control panel 6656 and the virtual foot switch 6654 supplyinformation to the system controller 6676 describing the physicalinteraction of the surgeon's finger and foot relative to a projectedcontrol panel image and the projected foot switch image. The systemcontroller 6676 responds to the information describing the physicalinteraction with the projected image, and supplies control signals tothe surgical equipment 6652 and patient monitoring equipment 6660 tocontrol functionality of those components in response to the physicalinteraction information. The control, status and functionalityinformation describing the surgical equipment 6652 and patientmonitoring equipment 6660 flows to the system controller 6676, and afterthat information is interpreted by the system controller 6676, it isdelivered to a system display 6670, a monitor 6666, and/or a heads updisplay 6668 for presentation.

The communication links 6674 between the system controller 6676 and thesystem display 6670, the heads up display 6668, the monitor 6666, a tagprinter 6658 and output devices 6664 are all uni-directional, meaningthat the information flows from the system controller 6676 to thosecomponents and functions. In a similar manner, the communication links6674 between the system controller 6676 and a scanner 6672 and the inputdevices 6662 are also unidirectional, but the information flows from thecomponents 6662, 6672 to the system controller 6676. In certaincircumstances, certain control and status information may flow betweenthe system controller 6676 and the components 6658, 6660, 6662, 6664,6666, 6668, 6670, 6672 in order to control the functionality of thethose components.

Each communication link 6674 preferably has a unique identity so thatthe system controller 6676 can individually communicate with each of thecomponents of the virtual control system 6650. The unique identity ofeach communication link is preferable when some or all of thecommunication links 6674 are through the same medium, as would be thecase of optical and radio frequency communications. The unique identityof each communication link 6674 assures that the system controller 6676has the ability to exercise individual control over each of thecomponents and functions on a very rapid and almost simultaneous manner.The unique identity of each communication link 6674 can be achieved byusing different frequencies for each communication link 6674 or by usingunique address and identification codes associated with thecommunications transferred over each communication link 6674.

In one aspect, the present disclosure provides illustrates a surgicalcommunication and control headset that interfaces with the surgical hub206 described in connection with FIGS. 1-11. Further examples aredisclosed in U.S. Patent Application Publication No. 2009/0046146,titled SURGICAL COMMUNICATION AND CONTROL SYSTEM, which published onFeb. 19, 2009, which is herein incorporated by reference in itsentirety. FIG. 137 illustrates a diagram 6680 of a beam source andcombined beam detector system utilized as a device control mechanism inan operating theater. The system 6680 is configured and wired to allowfor device control with the overlay generated on the primary proceduraldisplay. The footswitch shows a method to allow the user to click oncommand icons that would appear on the screen while the beam source isused to aim at the particular desired command icon to be clicked. Thecontrol system graphic user interface (GUI) and device control processorcommunicate and parameters are changed using the system. The system 6680includes a display 6684 coupled to a beam detecting sensor 6682 and ahead mounted source 6686. The beam detecting sensor 6682 is incommunication with a control system GUI overlay processor and beamsource processor 6688. The surgeon operates a footswitch 6692 or otheradjunctive switch, which provides a signal to a device control interfaceunit 6694.

The system 6680 will provide a means for a sterile clinician to controlprocedural devices in an easy and quick, yet hands free and centralizedfashion. The ability to maximize the efficiency of the operation andminimize the time a patient is under anesthesia is important to the bestpatient outcomes. It is common for surgeons, cardiologists orradiologists to verbally request adjustments be made to certain medicaldevices and electronic equipment used in the procedure outside thesterile field. It is typical that he or she must rely on another staffmember to make the adjustments he or she needs to settings on devicessuch as cameras, bovies, surgical beds, shavers, insufflators,injectors, to name a few. In many circumstances, having to command astaff member to make a change to a setting can slow down a procedurebecause the non-sterile staff member is busy with another task. Thesterile physician cannot adjust non-sterile equipment withoutcompromising sterility, so he or she must often wait for the non-sterilestaff member to make the requested adjustment to a certain device beforeresuming the procedure.

The system 6680 allows a user to use a beam source and beam detector toregenerate a pointer overlay coupled with a GUI and a concurrentswitching method (i.e., a foot switch, etc.) to allow the clinician toclick through commands on the primary display. In one aspect, a GUIcould appear on the procedural video display when activated, such aswhen the user tilts his or her head twice to awaken it or steps on afoot switch provided with the system. Or it is possible that a righthead tilt wakes up the system, and a left head tilt simply activates thebeam source. When the overlay (called device control GUI overlay)appears on the screen it shows button icons representing varioussurgical devices and the user can use the beam source, in this case alaser beam, to aim at the button icons. Once the laser is over theproper button icon, a foot switch, or other simultaneous switch methodcan be activated, effectively acting like a mouse click on a computer.For example a user can “wake up” the system, causing a the devicecontrol GUI overlay to pop up that lists button icons on the screen,each one labeled as a corresponding procedural medical device. The usercan point the laser at the correct box or device and click a foot pedal(or some other concurrent control—like voice control, waistband button,etc.) to make a selection, much like clicking a mouse on a computer. Thesterile physician can then select “insufflator, for example” Thesubsequent screen shows arrow icons that can be clicked for varioussettings for the device that need to be adjusted (pressure, rate, etc.).In one iteration, the user can then can point the laser at the up arrowand click the foot pedal repeatedly until the desired setting isattained.

In one aspect, components of the system 6680 could be coupled withexisting robotic endoscope holders to “steer” a rigid surgicalendoscopic camera by sending movement commands to the robotic endoscopeholding arm (provided separately, i.e., AESOP by Computer Motion). Theendoscope is normally held by an assistant nurse or resident physician.There are robotic and mechanical scope holders currently on the marketand some have even had been introduced with voice control. However,voice control systems have often proven cumbersome, slow and inaccurate.This aspect would employ a series of software and hardware components toallow the overlay to appear as a crosshair on the primary proceduralvideo screen. The user could point the beam source at any part of thequadrant and click a simultaneous switch, such as a foot pedal, to sendmovement commands to the existing robotic arm, which, when coupled withthe secondary trigger (i.e., a foot switch, waist band switch, etc.)would send a command to adjust the arm in minute increments in thedirection of the beam source. It could be directed by holding down thesecondary trigger until the desired camera angle and position isachieved and then released. This same concept could be employed forsurgical bed adjustments by having the overlay resemble the controls ofa surgical bed. The surgical bed is commonly adjusted during surgery toallow better access to the anatomy. Using the combination of the beamsource, in this case a laser, a beam detecting sensor such as a camera,a control system GUI overlay processing unit and beam source processor,and a device control interface unit, virtually any medical device couldbe controlled through this system. Control codes would be programmedinto the device control interface unit, and most devices can beconnected using an RS-232 interface, which is a standard for serialbinary data signals connecting between a DTE (Data Terminal Equipment)and a DCE (Data Circuit-terminating Equipment). The present inventionwhile described with reference to application in the medical field canbe expanded/modified for use in other fields. Another use of thisinvention could be in helping those who are without use of their handsdue to injury or handicap or for professions where the hands areoccupied and hands free interface is desired.

Surgical Hub with Direct Interface Control with Secondary SurgeonDisplay Units Designed to be within the Sterile Field and Accessible forInput and Display by the Surgeon

In one aspect, the surgical hub 206 provides a secondary user interfacethat enables display and control of surgical hub 206 functions from withthe sterile field. The secondary display could be used to change displaylocations, what information is displayed where, pass off control ofspecific functions or devices.

During a surgical procedure, the surgeon may not have a user interfacedevice accessible for interactive input by the surgeon and displaywithin the sterile field. Thus, the surgeon cannot interface with theuser interface device and the surgical hub from within the sterile fieldand cannot control other surgical devices through the surgical hub fromwithin the sterile field.

One solution provides a display unit designed to be used within thesterile field and accessible for input and display by the surgeon toallow the surgeon to have interactive input control from the sterilefield to control other surgical devices coupled to the surgical hub. Thedisplay unit is sterile and located within the sterile field to allowthe surgeons to interface with the display unit and the surgical hub todirectly interface and configure instruments as necessary withoutleaving the sterile field. The display unit is a master device and maybe used for display, control, interchanges of tool control, allowingfeeds from other surgical hubs without the surgeon leaving the sterilefield.

In one aspect, the present disclosure provides a control unit,comprising an interactive touchscreen display, an interface configuredto couple the interactive touchscreen display to a surgical hub, aprocessor, and a memory coupled to the processor. The memory storesinstructions executable by the processor to receive input commands fromthe interactive touchscreen display located inside a sterile field andtransmits the input commands to a surgical hub to control devicescoupled to the surgical hub located outside the sterile field.

In another aspect, the present disclosure provides a control unit,comprising an interactive touchscreen display, an interface configuredto couple the interactive touchscreen display to a surgical hub, and acontrol circuit configured to receive input commands from theinteractive touchscreen display located inside a sterile field andtransmit the input commands to a surgical hub to control devices coupledto the surgical hub located outside the sterile field.

In another aspect, the present disclosure provides a non-transitorycomputer readable medium storing computer readable instructions which,when executed, causes a machine to receive input commands from aninteractive touchscreen display located inside a sterile field andtransmit the input commands to a surgical hub through an interfaceconfigured to couple the interactive touchscreen display to the surgicalhub to control devices coupled to the surgical hub located outside thesterile field.

Providing a display unit designed to be used within the sterile fieldand accessible for input and display by the surgeon provides the surgeoninteractive input control from the sterile field to control othersurgical devices coupled to the surgical hub.

This display unit within the sterile field is sterile and allows thesurgeons to interface with it and the surgical hub. This gives thesurgeon control of the instruments coupled to the surgical hub andallows the surgeon to directly interface and configure the instrumentsas necessary without leaving the sterile field. The display unit is amaster device and may be used for display, control, interchanges of toolcontrol, allowing feeds from other surgical hubs without the surgeonleaving the sterile field.

In various aspects, the present disclosure provides a secondary userinterface to enable display and control of surgical hub functions fromwithin a sterile field. This control could be a display device like anI-pad, e.g., a portable interactive touchscreen display deviceconfigured to be introduced into the operating theater in a sterilemanner. It could be paired like any other device or it could be locationsensitive. The display device would be allowed to function in thismanner whenever the display device is placed over a specific location ofthe draped abdomen of the patient during a surgical procedure. In otheraspects, the present disclosure provides a smart retractor and a smartsticker. These and other aspects are described hereinbelow.

In one aspect, the present disclosure provides a secondary userinterface to enable display and control of surgical hub functions fromwithin the sterile field. In another aspect, the secondary display couldbe used to change display locations, determine what information andwhere the information is displayed, and pass off control of specificfunctions or devices.

There are four types of secondary surgeon displays in two categories.One type of secondary surgeon display units is designed to be usedwithin the sterile field and accessible for input and display by thesurgeon within the sterile field interactive control displays. Sterilefield interactive control displays may be shared or common sterile fieldinput control displays.

A sterile field display may be mounted on the operating table, on astand, or merely laying on the abdomen or chest of the patient. Thesterile field display is sterile and allows the surgeons to interfacewith the sterile field display and the surgical hub. This gives thesurgeon control of the system and allows them to directly interface andconfigure the sterile field display as necessary. The sterile fielddisplay may be configured as a master device and may be used fordisplay, control, interchanges of tool control, allowing feeds fromother surgical hubs, etc.

In one aspect, the sterile field display may be employed to re-configurethe wireless activation devices within the operating theater (OR) andtheir paired energy device if a surgeon hands the device to another.FIGS. 138A-138E illustrate various types of sterile field control anddata input consoles 6700, 6702, 6708, 6712, 6714 according to variousaspects of the present disclosure. Each of the disclosed sterile fieldcontrol and data input consoles 6700, 6702, 6708, 6712, 6714 comprise atleast one touchscreen 6701, 6704/6706, 6709, 6713, 6716 input/outputdevice layered on the top of an electronic visual display of aninformation processing system. The sterile field control and data inputconsoles 6700, 6702, 6708, 6712, 6714 may include batteries as a powersource. Some include a cable 6710 to connect to a separate power sourceor to recharge the batteries. A user can give input or control theinformation processing system through simple or multi-touch gestures bytouching the touchscreen 6701, 6704/6706, 6709, 6713, 6716 with astylus, one or more fingers, or a surgical tool. The sterile fieldcontrol and data input consoles 6700, 6702, 6708, 6712, 6714 may be usedto re-configure wireless activation devices within the operating theaterand a paired energy device if a surgeon hands the device to anothersurgeon. The sterile field control and data input consoles 6700, 6702,6708, 6712, 6714 may be used to accept consult feeds from anotheroperating theater where it would then configure a portion of theoperating theater screens or all of them to mirror the other operatingtheater so the surgeon is able to see what is needed to help. Thesterile field control and data input consoles 6700, 6702, 6708, 6712,6714 are configured to communicate with the surgical hub 206.Accordingly, the description of the surgical hub 206 discussed inconnection with FIGS. 1-11 is incorporated in this section by reference.

FIG. 138A illustrates a single zone sterile field control and data inputconsole 6700, according to one aspect of the present disclosure. Thesingle zone console 6700 is configured for use in a single zone within asterile field. Once deployed in a sterile field, the single zone console6700 can receive touchscreen inputs from a user in the sterile field.The touchscreen 6701 enables the user to interact directly with what isdisplayed, rather than using a mouse, touchpad, or other such devices(other than a stylus or surgical tool). The single zone console 6700includes wireless communication circuits to communicate wirelessly tothe surgical hub 206.

FIG. 138B illustrates a multi zone sterile field control and data inputconsole 6702, according to one aspect of the present disclosure. Themulti zone console 6702 comprises a first touchscreen 6704 to receive aninput from a first zone of a sterile field and a second touchscreen 6706to receive an input from a second zone of a sterile field. The multizone console 6702 is configured to receive inputs from multiple users ina sterile field. The multi zone console 6702 includes wirelesscommunication circuits to communicate wirelessly to the surgical hub206. Accordingly, the multi zone sterile field control and data inputconsole 6702 comprises an interactive touchscreen display with multipleinput and output zones.

FIG. 138C illustrates a tethered sterile field control and data inputconsole 6708, according to one aspect of the present disclosure. Thetethered console 6708 includes a cable 6710 to connect the tetheredconsole 6708 to the surgical hub 206 via a wired connection. The cable6710 enables the tethered console 6708 to communicate over a wired linkin addition to a wireless link. The cable 6710 also enables the tetheredconsole 6708 to connect to a power source for powering the console 6708and/or recharging the batteries in the console 6708.

FIG. 138D illustrates a battery operated sterile field control and datainput console 6712, according to one aspect of the present disclosure.The sterile field console 6712 is battery operated and includes wirelesscommunication circuits to communicate wirelessly with the surgical hub206. In particular, in one aspect, the sterile field console 6712 isconfigured to communicate with any of the modules coupled to the hub 206such as the generator module 240. Through the sterile field console6712, the surgeon can adjust the power output level of a generator usingthe touchscreen 6713 interface. One example is described below inconnection with FIG. 138E.

FIG. 138E illustrates a battery operated sterile field control and datainput console 6714, according to one aspect of the present disclosure.The sterile field console 6714 includes a user interface displayed onthe touchscreen of a generator. The surgeon can thus control the outputof the generator by touching the up/down arrow icons 6718A, 6718B thatincrease/decrease the power output of the generator module 240.Additional icons 6719 enable access to the generator module settings6174, volume 6178 using the +/− icons, among other features directlyfrom the sterile field console 6714. The sterile field console 6714 maybe employed to adjust the settings or reconfigure other wirelessactivations devices or modules coupled to the hub 206 within theoperating theater and their paired energy device when the surgeon handsthe sterile field console 6714 to another.

FIGS. 139A-139B illustrate a sterile field console 6700 in use in asterile field during a surgical procedure, according to one aspect ofthe present disclosure. FIG. 139A shows the sterile field console 6714positioned in the sterile field near two surgeons engaged in anoperation. In FIG. 139B, one of the surgeons is shown tapping thetouchscreen 6701 of the sterile field console with a surgical tool 6722to adjust the output of a modular device coupled to the surgical hub206, reconfigure the modular device, or an energy device paired with themodular device coupled to the surgical hub 206.

In another aspect, the sterile field display may be employed to acceptconsult feeds from another operating room (OR), such as anotheroperating theater or surgical hub 206, where it would then configure aportion of the OR screens or all of them to mirror the other ORs so thesurgeon could see what is needed to help. FIG. 140 illustrates a process6750 for accepting consult feeds from another operating room, accordingto one aspect of the present disclosure. The sterile field control anddata input consoles 6700, 6702, 6708, 6712, 6714 shown in FIGS.138A-138E, 139A-139B may be used as an interact-able scalable secondarydisplay allowing the surgeon to overlay other feeds or images from laserDoppler image scanning arrays or other image sources. The sterile fieldcontrol and data input consoles 6700, 6702, 6708, 6712, 6714 may be usedto call up a pre-operative scan or image to review. Laser Dopplertechniques are described in U.S. Provisional Patent Application No.62/611,341, filed Dec. 28, 2017, and titled INTERACTIVE SURGICALPLATFORM, which is incorporated herein by reference in its entirety.

It is recognized that the tissue penetration depth of light is dependenton the wavelength of the light used. Thus, the wavelength of the lasersource light may be chosen to detect particle motion (such a bloodcells) at a specific range of tissue depth. A laser Doppler employsmeans for detecting moving particles such as blood cells based at avariety of tissue depths based on the laser light wavelength. A lasersource may be directed to a surface of a surgical site. A blood vessel(such as a vein or artery) may be disposed within the tissue at somedepth δ from the tissue surface. Red laser light (having a wavelength inthe range of about 635 nm to about 660 nm) may penetrate the tissue to adepth of about 1 mm. Green laser light (having a wavelength in the rangeof about 520 nm to about 532 nm) may penetrate the tissue to a depth ofabout 2-3 mm. Blue laser light (having a wavelength in the range ofabout 405 nm to about 445 nm) may penetrate the tissue to a depth ofabout 4 mm or greater. A blood vessel may be located at a depth of about2-3 mm below the tissue surface. Red laser light will not penetrate tothis depth and thus will not detect blood cells flowing within thisvessel. However, both green and blue laser light can penetrate thisdepth. Therefore, scattered green and blue laser light from the bloodcells will result in an observed Doppler shift in both the green andblue.

In some aspects, a tissue may be probed by red, green, and blue laserillumination in a sequential manner and the effect of such illuminationmay be detected by a CMOS imaging sensor over time. It may be recognizedthat sequential illumination of the tissue by laser illumination atdiffering wavelengths may permit a Doppler analysis at varying tissuedepths over time. Although red, green, and blue laser sources may beused to illuminate the surgical site, it may be recognized that otherwavelengths outside of visible light (such as in the infrared orultraviolet regions) may be used to illuminate the surgical site forDoppler analysis. The imaging sensor information may be provided to thesterile field control and data input consoles 6700, 6702, 6708, 6712,6714.

The sterile field control and data input consoles 6700, 6702, 6708,6712, 6714 provide access to past recorded data. In one operatingtheater designated as OR1, the sterile field control and data inputconsoles 6700, 6702, 6708, 6712, 6714 may be configured as “consultants”and to erase all data when the consultation is complete. In anotheroperating theater designated as OR3 (operating room 3), the sterilefield control and data input consoles 6700, 6702, 6708, 6712, 6714 maybe configured as a “consultees” and are configured to record all datareceived from operating theater OR1 (operating room 1) sterile fieldcontrol and data input consoles 6700, 6702, 6708, 6712, 6714. Theseconfigurations are summarized in TABLE 2 below:

TABLE 2 Sterile Field Control And Data Sterile Field Control And DataInput Console In OR1 Input Console In OR3 Access to past recorded dataOR1 Consultant OR 3 Consultee Erase data when done Record all data

In one implementation of the process 6750, operating theater OR1receives 6752 a consult request from OR3. Data is transferred to the OR1sterile field control and data input console 6700, for example. The datais temporarily stored 6754. The data is backed up in time and the OR1view 6756 of the temporary data begins on the OR1 sterile field controland data input console 6700 touchscreen 6701. When the view is complete,the data is erased 6758 and control returns 6760 to OR1. The data isthen erased 6762 from the OR1 sterile field control and data inputconsole 6700 memory.

In yet another aspect, the sterile field display may be employed as aninteractable scalable secondary display allowing the surgeon to overlayother feeds or images like laser Doppler scanning arrays. In yet anotheraspect, the sterile field display may be employed to call up apre-operative scan or image to review. Once vessel path and depth anddevice trajectory are estimated, the surgeon employs a sterile fieldinteractable scalable secondary display allowing the surgeon to overlayother feeds or images.

FIG. 141 is a diagram 6770 that illustrates a technique for estimatingvessel path, depth, and device trajectory. Prior to dissecting a vessel6772, 6774 located below the surface of the tissue 6775 using a standardapproach, the surgeon estimates the path and depth of the vessel 6772,6774 and a trajectory 6776 of a surgical device 6778 will take to reachthe vessel 6772, 6774. It is often difficult to estimate the path anddepth 6776 of a vessel 6772, 6774 located below the surface of thetissue 6775 because the surgeon cannot accurately visualize the locationof the vessel 6772, 6774 path and depth 6776.

FIGS. 142A-142D illustrate multiple real time views of images of avirtual anatomical detail for dissection including perspective views(FIGS. 142A, 142C) and side views (FIGS. 142B, 142D). The images aredisplayed on a sterile field display of tablet computer or sterile fieldcontrol and data input console employed as an interactable scalablesecondary display allowing the surgeon to overlay other feeds or images,according to one aspect of the present disclosure. The images of thevirtual anatomy enable the surgeon to more accurately predict the pathand depth of a vessel 6772, 6774 located below the surface of the tissue6775 as shown in FIG. 141 and the best trajectory 6776 of the surgicaldevice 6778.

FIG. 142A is a perspective view of a virtual anatomy 6780 displayed on atablet computer or sterile field control and data input console. FIG.142B is a side view of the virtual anatomy 6780 shown in FIG. 142A,according to one aspect of the present disclosure. With reference toFIGS. 142A-142B, in one aspect, the surgeon uses a smart surgical device6778 and a tablet computer to visualize the virtual anatomy 6780 in realtime and in multiple views. The three dimensional perspective viewincludes a portion of tissue 6775 in which the vessels 6772, 6774 arelocated below surface. The portion of tissue is overlaid with a grid6786 to enable the surgeon to visualize a scale and gauge the path anddepth of the vessels 6772, 6774 at target locations 6782, 6784 eachmarked by an X. The grid 6786 also assists the surgeon determine thebest trajectory 6776 of the surgical device 6778. As illustrated, thevessels 6772, 6774 have an unusual vessel path.

FIG. 142C illustrates a perspective view of the virtual anatomy 6780 fordissection, according to one aspect of the present disclosure. FIG. 142Dis a side view of the virtual anatomy 6780 for dissection, according toone aspect of the present disclosure. With reference to FIGS. 142C-142D,using the tablet computer, the surgeon can zoom and pan 360° to obtainan optimal view of the virtual anatomy 6780 for dissection. The surgeonthen determines the best path or trajectory 6776 to insert the surgicaldevice 6778 (e.g., a dissector in this example). The surgeon may viewthe anatomy in a three-dimensional perspective view or any one of sixviews. See for example the side view of the virtual anatomy in FIG. 142Dand the insertion of the surgical device 6778 (e.g., the dissector).

In another aspect, a sterile field control and data input console mayallow live chatting between different departments, such as, for example,with the oncology or pathology department, to discuss margins or otherparticulars associated with imaging. The sterile field control and datainput console may allow the pathology department to tell the surgeonabout relationships of the margins within a specimen and show them tothe surgeon in real time using the sterile field console.

In another aspect, a sterile field control and data input console may beused to change the focus and field of view of its own image or controlthat of any of the other monitors coupled to the surgical hub.

In another aspect, a sterile field control and data input console may beused to display the status of any of the equipment or modules coupled tothe surgical hub 206. Knowledge of which device coupled to the surgicalhub 206 is being used may be obtained via information such as the deviceis not on the instrument pad or on-device sensors. Based on thisinformation, the sterile field control and data input console may changedisplay, configurations, switch power to drive one device, and notanother, one cord from capital to instrument pad and multiple cords fromthere. Device diagnostics may obtain knowledge that the device isinactive or not being used. Device diagnostics may be based oninformation such as the device is not on the instrument pad or basedon-device sensors.

In another aspect, a sterile field control and data input console may beused as a learning tool. The console may display checklists, proceduresteps, and/or sequence of steps. A timer/clock may be displayed tomeasure time to complete steps and/or procedures. The console maydisplay room sound pressure level as indicator for activity, stress,etc.

FIGS. 143A-143B illustrate a touchscreen display 6890 that may be usedwithin the sterile field, according to one aspect of the presentdisclosure. Using the touchscreen display 6890, a surgeon can manipulateimages 6892 displayed on the touchscreen display 6890 using a variety ofgestures such as, for example, drag and drop, scroll, zoom, rotate, tap,double tap, flick, drag, swipe, pinch open, pinch close, touch and hold,two-finger scroll, among others.

FIG. 143A illustrates an image 6892 of a surgical site displayed on atouchscreen display 6890 in portrait mode. FIG. 143B shows thetouchscreen display 6890 rotated 6894 to landscape mode and the surgeonuses his index finger 6896 to scroll the image 6892 in the direction ofthe arrows. FIG. 143C shows the surgeon using his index finger 6896 andthumb 6898 to pinch open the image 6892 in the direction of the arrows6899 to zoom in. FIG. 143D shows the surgeon using his index finger 6896and thumb 6898 to pinch close the image 6892 in the direction of thearrows 6897 to zoom out. FIG. 143E shows the touchscreen display 6890rotated in two directions indicated by arrows 6894, 6896 to enable thesurgeon to view the image 6892 in different orientations.

Outside the sterile field, control and static displays are used that aredifferent from the control and static displays used inside the sterilefield. The control and static displays located outside the sterile fieldprovide interactive and static displays for operating theater (OR) anddevice control. The control and static displays located outside thesterile field may include secondary static displays and secondarytouchscreens for input and output.

Secondary static non-sterile displays 107, 109, 119 (FIG. 2) for usedoutside the sterile field include monitors placed on the wall of theoperating theater, on a rolling stand, or on capital equipment. A staticdisplay is presented with a feed from the control device to which theyare attached and merely displays what is presented to it.

Secondary touch input screens located outside the sterile field may bepart of the visualization system 108 (FIG. 2), part of the surgical hub108 (FIG. 2), or may be fixed placement touch monitors on the walls orrolling stands. One difference between secondary touch input screens andstatic displays is that a user can interact with a secondary touch inputscreen by changing what is displayed on that specific monitor or others.For capital equipment applications, it could be the interface to controlthe setting of the connected capital equipment. The secondary touchinput screens and the static displays outside the sterile field can beused to preload the surgeon's preferences (instrumentation settings andmodes, lighting, procedure and preferred steps and sequence, music,etc.)

Secondary surgeon displays may include personal input displays with apersonal input device that functions similarly to the common sterilefield input display device but it is controlled by a specific surgeon.Personal secondary displays may be implemented in many form factors suchas, for example, a watch, a small display pad, interface glasses, etc. Apersonal secondary display may include control capabilities of a commondisplay device and since it is located on or controlled by a specificsurgeon, the personal secondary display would be keyed to him/herspecifically and would indicate that to others and itself. Generallyspeaking, a personal secondary display would normally not be useful toexchanging paired devices because they are not accessible to more thanone surgeon. Nevertheless, a personal secondary display could be used togrant permission for release of a device.

A personal secondary display may be used to provide dedicated data toone of several surgical personnel that wants to monitor something thatthe others typically would not want to monitor. In addition, a personalsecondary display may be used as the command module. Further, a personalsecondary display may be held by the chief surgeon in the operatingtheater and would give the surgeon the control to override any of theother inputs from anyone else. A personal secondary display may becoupled to a short range wireless, e.g., Bluetooth, microphone andearpiece allowing the surgeon to have discrete conversations or calls orthe personal secondary display may be used to broadcast to all theothers in the operating theater or other department.

FIG. 144 illustrates a surgical site 6900 employing a smart surgicalretractor 6902 comprising a direct interface control to a surgical hub206 (FIGS. 1-11), according to one aspect of the present disclosure. Thesmart surgical retractor 6902 helps the surgeon and operating roomprofessionals hold an incision or wound open during surgical procedures.The smart surgical retractor 6902 aids in holding back underlying organsor tissues, allowing doctors/nurses better visibility and access to theexposed area. With reference also to FIGS. 1-11, the smart surgicalretractor 6902 may comprise an input display 6904 operated by the smartsurgical retractor 6902. The smart surgical retractor 6902 may comprisea wireless communication device to communicate with a device connectedto a generator module 240 coupled to the surgical hub 206. Using theinput display 6904 of the smart surgical retractor 6902, the surgeon canadjust power level or mode of the generator module 240 to cut and/orcoagulate tissue. If using automatic on/off for energy delivery onclosure of an end effector on the tissue, the status of automatic on/offmay be indicated by a light, screen, or other device located on thesmart retractor 6902 housing. Power being used may be changed anddisplayed.

In one aspect, the smart surgical retractor 6902 can sense or know whatdevice/instrument 235 the surgeon is using, either through the surgicalhub 206 or RFID or other device placed on the device/instrument 235 orthe smart surgical retractor 6902, and provide an appropriate display.Alarm and alerts may be activated when conditions require. Otherfeatures include displaying the temperature of the ultrasonic blade,nerve monitoring, light source 6906 or fluorescence. The light source6906 may be employed to illuminate the surgical field of view 6908 andto charge photocells 6918 on single use sticker display that stick ontothe smart retractor 6902 (see FIG. 145, for example). In another aspect,the smart surgical retractor 6902 may include an augmented realityprojected on the patient's anatomy (e.g., like a vein viewer).

FIG. 145 illustrates a surgical site 6910 with a smart flexible stickerdisplay 6912 attached to the body/skin 6914 of a patient, according toone aspect of the present disclosure. As shown, the smart flexiblesticker display 6912 is applied to the body/skin 6914 of a patientbetween the area exposed by the surgical retractors 6916. In one aspect,the smart flexible sticker display 6912 may be powered by light, an onboard battery, or a ground pad. The flexible sticker display 6912 maycommunicate via short range wireless (e.g., Bluetooth) to a device, mayprovide readouts, lock power, or change power. The smart flexiblesticker display 6912 also comprises photocells 6918 to power the smartflexible sticker display 6912 using ambient light energy. The flexiblesticker display 6912 includes a display of a control panel 6920 userinterface to enable the surgeon to control devices 235 or other modulescoupled to the surgical hub 206 (FIGS. 1-11).

FIG. 146 is a logic flow diagram 6920 of a process depicting a controlprogram or a logic configuration to communicate from inside a sterilefield to a device located outside the sterile field, according to oneaspect of the present disclosure. In one aspect, a control unitcomprises an interactive touchscreen display, an interface configured tocouple the interactive touchscreen display to a surgical hub, aprocessor, and a memory coupled to the processor. The memory storesinstructions executable by the processor to receive 6922 input commandsfrom the interactive touchscreen display located inside a sterile fieldand transmits 6924 the input commands to a surgical hub to controldevices coupled to the surgical hub located outside the sterile field.

FIG. 147 illustrates a system for performing surgery. The systemcomprises a control box which includes internal circuitry; a surgicalinstrument including a distal element and techniques for sensing aposition or condition of said distal element; techniques associated withsaid surgical instrument for transmitting said sensed position orcondition to said internal circuitry of said control box; and fortransmitting said sensed position or condition from said internalcircuitry of said control box to a video monitor for display thereon,wherein said sensed position or condition is displayed on said videomonitor as an icon or symbol, further comprising a voltage source forgenerating a voltage contained entirely within said surgical instrument.Further examples are disclosed in U.S. Pat. No. 5,503,320, titledSURGICAL APPARATUS WITH INDICATOR, which issued on Apr. 2, 1996, whichis herein incorporated by reference in its entirety.

FIG. 147 shows schematically a system whereby data is transmitted to avideo monitor for display, such data relating to the position and/orcondition of one or more surgical instruments. As shown in FIG. 147, alaparoscopic surgical procedure is being performed wherein a pluralityof trocar sleeves 6930 are inserted through a body wall 6931 to provideaccess to a body cavity 6932. A laparoscope 6933 is inserted through oneof the trocar sleeves 6930 to provide illumination (light cable 6934 isshown leading toward a light source, not pictured) to the surgical siteand to obtain an image thereof. A camera adapter 6935 is attached at theproximal end of laparoscope 6933 and image cable 6936 extends therefromto a control box 6937 discussed in more detail below. Image cable inputsto image receiving port 416 on control box 6937.

Additional surgical instruments 6939, 6940 are inserted throughadditional trocar sleeves 6900 which extend through body wall 6931. InFIG. 147, instrument 6939 schematically illustrates an endoscopicstapling device, e.g., an Endo GIA* instrument manufactured by theassignee of this application, and instrument 6940 schematicallyillustrates a hand instrument, e.g., an Endo Grasp* device alsomanufactured by the present assignee. Additional and/or alternativeinstruments may also be utilized according to the present invention; theillustrated instruments are merely exemplary of surgical instrumentswhich may be utilized according to the present invention.

Instruments 6939, 6940 include adapters 6941, 6942 associated with theirrespective handle portions. The adapters electronically communicate withconductive mechanisms (not pictured). These mechanisms, which includeelectrically conductive contact members electrically connected by wires,cables and the like, are associated with the distal elements of therespective instruments, e.g., the anvil 6943 and cartridge 6944 of theEndo GIA* instrument, the jaws 6945, 6946 of the Endo Grasp* device, andthe like. The mechanisms are adapted to interrupt an electronic circuitwhen the distal elements are in a first position or condition and tocomplete the electronic circuit when the distal elements are in a secondposition or condition. A voltage source for the electronic circuit maybe provided in the surgical instrument, e.g., in the form of a battery,or supplied from control box 6937 through cables 6947, 6948.

Control box 6937 includes a plurality of jacks 6949 which are adapted toreceive cables 6947, 6948 and the like. Control box 6937 furtherincludes an outgoing adapter 6950 which is adapted to cooperate with acable 6951 for transmitting the laparoscopic image obtained by thelaparoscope 6933 together with data concerning surgical instruments6939, 6940 to video monitor 6952. Circuitry within control box 6937 isprovided for converting the presence of an interrupted circuit, e.g.,for the electronics within cable 6947 and the mechanism associated withthe distal elements of instrument 6939, to an icon or symbol for displayon video monitor 6952. Similarly, the circuitry within control box 6937is adapted to provide a second icon or symbol to video monitor 6952 whena completed circuit exists for cable 6947 and the associated mechanism.

Illustrative icons/symbols 6953, 6954 are shown on video monitor 6952.Icon 6953 shows a surgical staple and could be used to communicate tothe surgeon that the cartridge 6944 and anvil 6943 of instrument 6939are properly positioned to form staples in tissue 6955. Icon 6953 couldtake another form when the cartridge 6944 and anvil 6943 are notproperly positioned for forming staples, thereby interrupting thecircuit. Icon 6954 shows a hand instrument with jaws spread apart,thereby communicating to the surgeon that the jaws 6945, 6946 ofinstrument 6940 are open. Icon 6954 could take another form when jaws6945, 6946 are closed, thereby completing the circuit.

FIG. 148 illustrates a second layer of information overlaying a firstlayer of information. The second layer of information includes asymbolic representation of the knife overlapping the detected positionof the knife in the DLU depicted in the first layer of information.Further examples are disclosed in U.S. Pat. No. 9,283,054, titledSURGICAL APPARATUS WITH INDICATOR, which issued on Mar. 15, 2016, whichis herein incorporated by reference in its entirety.

Referring to FIG. 148, the second layer of information 6963 can overlayat least a portion of the first layer of information 6962 on the display6960. Furthermore, the touch screen 6961 can allow a user to manipulatethe second layer of information 6963 relative to the video feedback inthe underlying first layer of information 6962 on the display 6960. Forexample, a user can operate the touch screen 6961 to select, manipulate,reformat, resize, and/or otherwise modify the information displayed inthe second layer of information 6963. In certain aspects, the user canuse the touch screen 6961 to manipulate the second layer of information6963 relative to the surgical instrument 6964 depicted in the firstlayer of information 6962 on the display 6960. A user can select a menu,category and/or classification of the control panel 6967 thereof, forexample, and the second layer of information 6963 and/or the controlpanel 6967 can be adjusted to reflect the user's selection. In variousaspects, a user may select a category from the instrument feedbackcategory 6969 that corresponds to a specific feature or features of thesurgical instrument 6964 depicted in the first layer of information6962. Feedback corresponding to the user-selected category can move,locate itself, and/or “snap” to a position on the display 6960 relativeto the specific feature or features of the surgical instrument 6964. Forexample, the selected feedback can move to a position near and/oroverlapping the specific feature or features of the surgical instrument6964 depicted in the first layer of information 6962.

The instrument feedback menu 6969 can include a plurality of feedbackcategories, and can relate to the feedback data measured and/or detectedby the surgical instrument 6964 during a surgical procedure. Asdescribed herein, the surgical instrument 6964 can detect and/or measurethe position 6970 of a moveable jaw between an open orientation and aclosed orientation, the thickness 6973 of clamped tissue, the clampingforce 6976 on the clamped tissue, the articulation 6974 of the DLU 6965,and/or the position 6971, velocity 6972, and/or force 6975 of the firingelement, for example. Furthermore, the feedback controller in signalcommunication with the surgical instrument 6964 can provide the sensedfeedback to the display 6960, which can display the feedback in thesecond layer of information 6963. As described herein, the selection,placement, and/or form of the feedback data displayed in the secondlayer of information 6963 can be modified based on the user's input tothe touch screen 6961, for example.

When the knife of the DLU 6965 is blocked from view by the end effectorjaws 6966 and/or tissue T, for example, the operator can track and/orapproximate the position of the knife in the DLU 6964 based on thechanging value of the feedback data and/or the shifting position of thefeedback data relative to the DLU 6965 depicted in the underlying firstlayer of information 6962.

In various aspects, the display menu 6977 of the control panel 6967 canrelate to a plurality of categories, such as unit systems 6978 and/ordata modes 6979, for example. In certain aspects, a user can select theunit systems category 6978 to switch between unit systems, such asbetween metric and U.S. customary units, for example. Additionally, auser can select the data mode category 6979 to switch between types ofnumerical representations of the feedback data and/or types of graphicalrepresentations of the feedback data, for example. The numericalrepresentations of the feedback data can be displayed as numericalvalues and/or percentages, for example. Furthermore, the graphicalrepresentations of the feedback data can be displayed as a function oftime and/or distance, for example. As described herein, a user canselect the instrument controller menu 6980 from the control panel 6967to input directives for the surgical instrument 6964, which can beimplemented via the instrument controller and/or the microcontroller,for example. A user can minimize or collapse the control panel 6967 byselecting the minimize/maximize icon 6968, and can maximize orun-collapse the control panel 6967 by re-selecting the minimize/maximizeicon 6968.

FIG. 149 depicts a perspective view of a surgeon using a surgicalinstrument that includes a handle assembly housing and a wirelesscircuit board during a surgical procedure, with the surgeon wearing aset of safety glasses. The wireless circuit board transmits a signal toa set of safety glasses worn by a surgeon using the surgical instrumentduring a procedure. The signal is received by a wireless port on thesafety glasses. One or more lighting devices on a front lens of thesafety glasses change color, fade, or glow in response to the receivedsignal to indicate information to the surgeon about the status of thesurgical instrument. The lighting devices are disposable on peripheraledges of the front lens to not distract the direct line of vision of thesurgeon. Further examples are disclosed in U.S. Pat. No. 9,011,427,titled SURGICAL INSTRUMENT WITH SAFETY GLASSES, which issued on Apr. 21,2015, which is herein incorporated by reference in its entirety.

FIG. 149 shows a version of safety glasses 6991 that may be worn by asurgeon 6992 during a surgical procedure while using a medical device.In use, a wireless communications board housed in a surgical instrument6993 may communicate with a wireless port 6994 on safety glasses 6991.Exemplary surgical instrument 6993 is a battery-operated device, thoughinstrument 6993 could be powered by a cable or otherwise. Instrument6993 includes an end effector. Particularly, wireless communicationsboard 6995 transmits one or more wireless signals indicated by arrows(B, C) to wireless port 6994 of safety glasses 6991. Safety glasses 6991receive the signal, analyze the received signal, and display indicatedstatus information received by the signal on lenses 6996 to a user, suchas surgeon 6992, wearing safety glasses 6991. Additionally oralternatively, wireless communications board 6995 transmits a wirelesssignal to surgical monitor 6997 such that surgical monitor 6997 maydisplay received indicated status information to surgeon 6992, asdescribed above.

A version of the safety glasses 6991 may include lighting device onperipheral edges of the safety glasses 6991. A lighting device providesperipheral-vision sensory feedback of instrument 6993, with which thesafety glasses 6991 communicate to a user wearing the safety glasses6991. The lighting device may be, for example, a light-emitted diode(“LED”), a series of LEDs, or any other suitable lighting device knownto those of ordinary skill in the art and apparent in view of theteachings herein.

LEDs may be located at edges or sides of a front lens of the safetyglasses 6991 so not to distract from a user's center of vision whilestill being positioned within the user's field of view such that theuser does not need to look away from the surgical site to see thelighting device. Displayed lights may pulse and/or change color tocommunicate to the wearer of the safety glasses 6991 various aspects ofinformation retrieved from instrument 6993, such as system statusinformation or tissue sensing information (i.e., whether the endeffector has sufficiently severed and sealed tissue). Feedback fromhoused wireless communications board 6995 may cause a lighting device toactivate, blink, or change color to indicate information about the useof instrument 6993 to a user. For example, a device may incorporate afeedback mechanism based on one or more sensed tissue parameters. Inthis case, a change in the device output(s) based on this feedback insynch with a tone change may submit a signal through wirelesscommunications board 6995 to the safety glasses 6991 to triggeractivation of the lighting device. Such described means of activation ofthe lighting device should not be considered limiting as other means ofindicating status information of instrument 6993 to the user via thesafety glasses 6991 are contemplated. Further, the safety glasses 6991may be single-use or reusable eyewear. Button-cell power supplies suchas button-cell batteries may be used to power wireless receivers andLEDs of versions of safety glasses 6991, which may also include a housedwireless board and tri-color LEDs. Such button-cell power supplies mayprovide a low-cost means of providing sensory feedback of informationabout instrument 6993 when in use to surgeon 6992 wearing safety glasses6991.

FIG. 150 is a schematic diagram of a feedback control system forcontrolling a surgical instrument. The surgical instrument includes ahousing and an elongated shaft that extends distally from the housingand defines a first longitudinal axis. The surgical instrument alsoincludes a firing rod disposed in the elongated shaft and a drivemechanism disposed at least partially within the housing. The drivemechanism mechanically cooperates with the firing rod to move the firingrod. A motion sensor senses a change in the electric field (e.g.,capacitance, impedance, or admittance) between the firing rod and theelongated shaft. The measurement unit determines a parameter of themotion of the firing rod, such as the position, speed, and direction ofthe firing rod, based on the sensed change in the electric field. Acontroller uses the measured parameter of the motion of the firing rodto control the drive mechanism. Further examples are disclosed in U.S.Pat. No. 8,960,520, titled METHOD AND APPARATUS FOR DETERMININGPARAMETERS OF LINEAR MOTION IN A SURGICAL INSTRUMENT, which issued onFeb. 24, 2015, which is herein incorporated by reference in itsentirety.

With reference to FIG. 150, aspects of the present disclosure mayinclude a feedback control system 6150. The system 6150 includes afeedback controller 6152. The surgical instrument 6154 is connected tothe feedback controller 6152 via a data port, which may be either wired(e.g., FireWire®, USB, Serial RS232, Serial RS485, USART, Ethernet,etc.) or wireless (e.g., Bluetooth®, ANT3®, KNX®, Z-Wave X10®, WirelessUSB®, Wi-Fi®, IrDA®, nanoNET®, TinyOS®, ZigBee®, 802.11 IEEE, and otherradio, infrared, UHF, VHF communications and the like). The feedbackcontroller 6152 is configured to store the data transmitted to it by thesurgical instrument 6154 as well as process and analyze the data. Thefeedback controller 6152 is also connected to other devices, such as avideo display 6154, a video processor 6156 and a computing device 6158(e.g., a personal computer, a PDA, a smartphone, a storage device,etc.). The video processor 6156 is used for processing output datagenerated by the feedback controller 6152 for output on the videodisplay 6154. The computing device 6158 is used for additionalprocessing of the feedback data. In one aspect, the results of thesensor feedback analysis performed by a microcontroller may be storedinternally for later retrieval by the computing device 6158.

FIG. 151 illustrates a feedback controller 6152 including an on-screendisplay (OSD) module and a heads-up-display (HUD) module. The modulesprocess the output of a microcontroller for display on various displays.More specifically, the OSD module overlays text and/or graphicalinformation from the feedback controller 6152 over other video imagesreceived from the surgical site via cameras disposed therein. Themodified video signal having overlaid text is transmitted to the videodisplay allowing the user to visualize useful feedback information fromthe surgical instrument 6154 and/or feedback controller 6152 while stillobserving the surgical site. The feedback controller 6152 includes adata port 6160 coupled to a microcontroller which allows the feedbackcontroller 6152 to be connected to the computing device 6158 (FIG. 150).The data port 6160 may provide for wired and/or wireless communicationwith the computing device 6158 providing for an interface between thecomputing device 6158 and the feedback controller 6152 for retrieval ofstored feedback data, configuration of operating parameters of thefeedback controller 6152 and upgrade of firmware and/or other softwareof the feedback controller 6152.

The feedback controller 6152 includes a housing 6162 and a plurality ofinput and output ports, such as a video input 6164, a video output 6166,and a HUD display output 6168. The feedback controller 6152 alsoincludes a screen for displaying status information concerning thefeedback controller 6152. Further examples are disclosed in U.S. Pat.No. 8,960,520, titled METHOD AND APPARATUS FOR DETERMINING PARAMETERS OFLINEAR MOTION IN A SURGICAL INSTRUMENT, which issued on Feb. 24, 2015,which is herein incorporated by reference in its entirety.

Visualization System

During a surgical procedure, a surgeon may be required to manipulatetissues to effect a desired medical outcome. The actions of the surgeonare limited by what is visually observable in the surgical site. Thus,the surgeon may not be aware, for example, of the disposition ofvascular structures that underlie the tissues being manipulated duringthe procedure. Since the surgeon is unable to visualize the vasculaturebeneath a surgical site, the surgeon may accidentally sever one or morecritical blood vessels during the procedure. The solution is a surgicalvisualization system that can acquire imaging data of the surgical sitefor presentation to a surgeon, in which the presentation can includeinformation related to the presence and depth of vascular structureslocated beneath the surface of a surgical site.

In one aspect, the surgical hub 106 incorporates a visualization system108 to acquire imaging data during a surgical procedure. Thevisualization system 108 may include one or more illumination sourcesand one or more light sensors. The one or more illumination sources andone or more light sensors may be incorporated together into a singledevice or may comprise one or more separate devices. The one or moreillumination sources may be directed to illuminate portions of thesurgical field. The one or more light sensors may receive lightreflected or refracted from the surgical field including light reflectedor refracted from tissue and/or surgical instruments. The followingdescription includes all of the hardware and software processingtechniques disclosed above and in those applications incorporated hereinby reference as presented above.

In some aspects, the visualization system 108 may be integrated into asurgical system 100 as disclosed above and depicted in FIGS. 1 and 2. Inaddition to the visualization system 108, the surgical system 100 mayinclude one or more hand-held intelligent instruments 112, amulti-functional robotic system 110, one or more visualization systems108, and a centralized surgical hub system 106, among other components.The centralized surgical hub system 106 may control several functions adisclosed above and also depicted in FIG. 3. In one non-limitingexample, such functions may include supplying and controlling power toany number of powered surgical devices. In another non-limiting example,such functions may include controlling fluid supplied to and evacuatedfrom the surgical site. The centralized surgical hub system 106 may alsobe configured to manage and analyze data received from any of thesurgical system components as well as communicate data and otherinformation among and between the components of the surgical system. Thecentralized surgical hub system 106 may also be in data communicationwith a cloud computing system 104 as disclosed above and depicted, forexample, in FIG. 1.

In some non-limiting examples, imaging data generated by thevisualization system 108 may be analyzed by on-board computationalcomponents of the visualization system 108, and analysis results may becommunicated to the centralized surgical hub 106. In alternativenon-limiting examples, the imaging data generated by the visualizationsystem 108 may be communicated directly to the centralized surgical hub106 where the data may be analyzed by computational components in thehub system 106. The centralized surgical hub 106 may communicate theimage analysis results to any one or more of the other components of thesurgical system. In some other non-limiting examples, the centralizedsurgical hub may communicate the image data and/or the image analysisresults to the cloud computing system 104.

FIGS. 152A-D and FIGS. 153A-F depict various aspects of one example of avisualization system 2108 that may be incorporated into a surgicalsystem. The visualization system 2108 may include an imaging controlunit 2002 and a hand unit 2020. The imaging control unit 2002 mayinclude one or more illumination sources, a power supply for the one ormore illumination sources, one or more types of data communicationinterfaces (including USB, Ethernet, or wireless interfaces 2004), andone or more a video outputs 2006. The imaging control unit 2002 mayfurther include an interface, such as a USB interface 2010, configuredto transmit integrated video and image capture data to a USB enableddevice. The imaging control unit 2002 may also include one or morecomputational components including, without limitation, a processorunit, a transitory memory unit, a non-transitory memory unit, an imageprocessing unit, a bus structure to form data links among thecomputational components, and any interface (e.g. input and/or output)devices necessary to receive information from and transmit informationto components not included in the imaging control unit. Thenon-transitory memory may further contain instructions that whenexecuted by the processor unit, may perform any number of manipulationsof data that may be received from the hand unit 2020 and/orcomputational devices not included in the imaging control unit.

The illumination sources may include a white light source 2012 and oneor more laser light sources. The imaging control unit 2002 may includeone or more optical and/or electrical interfaces for optical and/orelectrical communication with the hand unit 2020. The one or more laserlight sources may include, as non-limiting examples, any one or more ofa red laser light source, a green laser light source, a blue laser lightsource, an infrared laser light source, and an ultraviolet laser lightsource. In some non-limiting examples, the red laser light source maysource illumination having a peak wavelength that may range between 635nm and 660 nm, inclusive. Non-limiting examples of a red laser peakwavelength may include about 635 nm, about 640 nm, about 645 nm, about650 nm, about 655 nm, about 660 nm, or any value or range of valuestherebetween. In some non-limiting examples, the green laser lightsource may source illumination having a peak wavelength that may rangebetween 520 nm and 532 nm, inclusive. Non-limiting examples of a greenlaser peak wavelength may include about 520 nm, about 522 nm, about 524nm, about 526 nm, about 528 nm, about 530 nm, about 532 nm, or any valueor range of values therebetween. In some non-limiting examples, the bluelaser light source may source illumination having a peak wavelength thatmay range between 405 nm and 445 nm, inclusive. Non-limiting examples ofa blue laser peak wavelength may include about 405 nm, about 410 nm,about 415 nm, about 420 nm, about 425 nm, about 430 nm, about 435 nm,about 440 nm, about 445 nm, or any value or range of valuestherebetween. In some non-limiting examples, the infrared laser lightsource may source illumination having a peak wavelength that may rangebetween 750 nm and 3000 nm, inclusive. Non-limiting examples of aninfrared laser peak wavelength may include about 750 nm, about 1000 nm,about 1250 nm, about 1500 nm, about 1750 nm, about 2000 nm, about 2250nm, about 2500 nm, about 2750 nm, 3000 nm, or any value or range ofvalues therebetween. In some non-limiting examples, the ultravioletlaser light source may source illumination having a peak wavelength thatmay range between 200 nm and 360 nm, inclusive. Non-limiting examples ofan ultraviolet laser peak wavelength may include about 200 nm, about 220nm, about 240 nm, about 260 nm, about 280 nm, about 300 nm, about 320nm, about 340 nm, about 360 nm, or any value or range of valuestherebetween.

In one non-limiting aspect, the hand unit 2020 may include a body 2021,a camera scope cable 2015 attached to the body 2021, and an elongatedcamera probe 2024. The body 2021 of the hand unit 2020 may include handunit control buttons 2022 or other controls to permit a healthprofessional using the hand unit 2020 to control the operations of thehand unit 2020 or other components of the imaging control unit 2002,including, for example, the light sources. The camera scope cable 2015may include one or more electrical conductors and one or more opticalfibers. The camera scope cable 2015 may terminate with a camera headconnector 2008 at a proximal end in which the camera head connector 2008is configured to mate with the one or more optical and/or electricalinterfaces of the imaging control unit 2002. The electrical conductorsmay supply power to the hand unit 2020, including the body 2021 and theelongated camera probe 2024, and/or to any electrical componentsinternal to the hand unit 2020 including the body 2021 and/or elongatedcamera probe 2024. The electrical conductors may also serve to providebi-directional data communication between any one or more components thehand unit 2020 and the imaging control unit 2002. The one or moreoptical fibers may conduct illumination from the one or moreillumination sources in the imaging control unit 2002 through the handunit body 2021 and to a distal end of the elongated camera probe 2024.In some non-limiting aspects, the one or more optical fibers may alsoconduct light reflected or refracted from the surgical site to one ormore optical sensors disposed in the elongated camera probe 2024, thehand unit body 2021, and/or the imaging control unit 2002.

FIG. 152B (a top plan view) depicts in more detail some aspects of ahand unit 2020 of the visualization system 2108. The hand unit body 2021may be constructed of a plastic material. The hand unit control buttons2022 or other controls may have a rubber overmolding to protect thecontrols while permitting them to be manipulated by the surgeon. Thecamera scope cable 2015 may have optical fibers integrated withelectrical conductors, and the camera scope cable 2015 may have aprotective and flexible overcoating such as PVC. In some non-limitingexamples, the camera scope cable 2015 may be about 10 ft. long to permitease of use during a surgical procedure. The length of the camera scopecable 2015 may range from about 5 ft. to about 15 ft. Non-limitingexamples of a length of the camera scope cable 2015 may be about 5 ft.,about 6 ft., about 7 ft., about 8 ft., about 9 ft., about 10 ft., about11 ft., about 12 ft., about 13 ft., about 14 ft., about 15 ft., or anylength or range of lengths therebetween. The elongated camera probe 2024may be fabricated from a rigid material such as stainless steel. In someaspects, the elongated camera probe 2024 may be joined with the handunit body 2021 via a rotatable collar 2026. The rotatable collar 2026may permit the elongated camera probe 2024 to be rotated with respect tothe hand unit body 2021. In some aspects, the elongated camera probe2024 may terminate at a distal end with a plastic window 2028 sealedwith epoxy.

The side plan view of the hand unit, depicted in FIG. 152C illustratesthat a light or image sensor 2030 maybe disposed at a distal end 2032 aof the elongated camera probe or within the hand unit body 2032 b. Insome alternative aspects, the light or image sensor 2030 may be disposewith additional optical elements in the imaging control unit 2002. FIG.152C further depicts an example of a light sensor 2030 comprising a CMOSimage sensor 2034 disposed within a mount 2036 having a radius of about4 mm. FIG. 152D illustrates aspects of the CMOS image sensor 2034,depicting the active area 2038 of the image sensor. Although the CMOSimage sensor in FIG. 152C is depicted to be disposed within a mount 2036having a radius of about 4 mm, it may be recognized that such a sensorand mount combination may be of any useful size to be disposed withinthe elongated camera probe 2024, the hand unit body 2021, or in theimage control unit 2002. Some non-limiting examples of such alternativemounts may include a 5.5 mm mount 2136 a, a 4 mm mount 2136 b, a 2.7 mmmount 2136 c, and a 2 mm mount 2136 d. It may be recognized that theimage sensor may also comprise a CCD image sensor. The CMOS or CCDsensor may comprise an array of individual light sensing elements(pixels).

FIGS. 153A-153F depict various aspects of some examples of illuminationsources and their control that may be incorporated into thevisualization system 2108.

FIG. 153A illustrates an aspect of a laser illumination system having aplurality of laser bundles emitting a plurality of wavelengths ofelectromagnetic energy. As can be seen in the figure, the illuminationsystem 2700 may comprise a red laser bundle 2720, a green laser bundle2730, and a blue laser bundle 2740 that are all optically coupledtogether though fiber optics 2755. As can be seen in the figure, each ofthe laser bundles may have a corresponding light sensing element orelectromagnetic sensor 2725, 2735, 2745 respectively, for sensing theoutput of the specific laser bundle or wavelength.

Additional disclosures regarding the laser illumination system depictedin FIG. 153A for use in a surgical visualization system 2108 may befound in U.S. Patent Application Publication No. 2014/0268860, titledCONTROLLING THE INTEGRAL LIGHT ENERGY OF A LASER PULSE filed on Mar. 15,2014, which issued on Oct. 3, 2017 as U.S. Pat. No. 9,777,913, thecontents thereof being incorporated by reference herein in its entiretyand for all purposes.

FIG. 153B illustrates the operational cycles of a sensor used in rollingreadout mode. It will be appreciated that the x direction corresponds totime and the diagonal lines 2202 indicate the activity of an internalpointer that reads out each frame of data, one line at time. The samepointer is responsible for resetting each row of pixels for the nextexposure period. The net integration time for each row 2219 a-c isequivalent, but they are staggered in time with respect to one anotherdue to the rolling reset and read process. Therefore, for any scenarioin which adjacent frames are required to represent differentconstitutions of light, the only option for having each row beconsistent is to pulse the light between the readout cycles 2230 a-c.More specifically, the maximum available period corresponds to the sumof the blanking time plus any time during which optical black oroptically blind (OB) rows (2218, 2220) are serviced at the start or endof the frame.

FIG. 153B illustrates the operational cycles of a sensor used in rollingreadout mode or during the sensor readout 2200. The frame readout maystart at and may be represented by vertical line 2210. The read outperiod is represented by the diagonal or slanted line 2202. The sensormay be read out on a row by row basis, the top of the downwards slantededge being the sensor top row 2212 and the bottom of the downwardsslanted edge being the sensor bottom row 2214. The time between the lastrow readout and the next readout cycle may be called the blanking time2216 a-d. It may be understood that the blanking time 2216 a-d may bethe same between success readout cycles or it may differ between successreadout cycles. It should be noted that some of the sensor pixel rowsmight be covered with a light shield (e.g., a metal coating or any othersubstantially black layer of another material type). These covered pixelrows may be referred to as optical black rows 2218 and 2220. Opticalblack rows 2218 and 2220 may be used as input for correction algorithms.

As shown in FIG. 153B, these optical black rows 2218 and 2220 may belocated on the top of the pixel array or at the bottom of the pixelarray or at the top and the bottom of the pixel array. In some aspects,it may be desirable to control the amount of electromagnetic radiation,e.g., light, that is exposed to a pixel, thereby integrated oraccumulated by the pixel. It will be appreciated that photons areelementary particles of electromagnetic radiation. Photons areintegrated, absorbed, or accumulated by each pixel and converted into anelectrical charge or current. In some aspects, an electronic shutter orrolling shutter may be used to start the integration time (2219 a-c) byresetting the pixel. The light will then integrate until the nextreadout phase. In some aspects, the position of the electronic shuttercan be moved between two readout cycles 2202 in order to control thepixel saturation for a given amount of light. In some alternativeaspects lacking an electronic shutter, the integration time 2219 a-c ofthe incoming light may start during a first readout cycle 2202 and mayend at the next readout cycle 2202, which also defines the start of thenext integration. In some alternative aspects, the amount of lightaccumulated by each pixel may be controlled by a time during which lightis pulsed 2230 a-d during the blanking times 2216 a-d. This ensures thatall rows see the same light issued from the same light pulse 2230 a-c.In other words, each row will start its integration in a first darkenvironment 2231, which may be at the optical black back row 2220 ofread out frame (m) for a maximum light pulse width, and will thenreceive a light strobe and will end its integration in a second darkenvironment 2232, which may be at the optical black front row 2218 ofthe next succeeding read out frame (m+1) for a maximum light pulsewidth. Thus, the image generated from the light pulse 2230 a-c will besolely available during frame (m+1) readout without any interferencewith frames (m) and (m+2).

It should be noted that the condition to have a light pulse 2230 a-c tobe read out only in one frame and not interfere with neighboring framesis to have the given light pulse 2230 a-c firing during the blankingtime 2216. Because the optical black rows 2218, 2220 are insensitive tolight, the optical black back rows 2220 time of frame (m) and theoptical black front rows 2218 time of frame (m+1) can be added to theblanking time 2216 to determine the maximum range of the firing time ofthe light pulse 2230.

In some aspects, FIG. 153B depicts an example of a timing diagram forsequential frame captures by a conventional CMOS sensor. Such a CMOSsensor may incorporate a Bayer pattern of color filters, as depicted inFIG. 153C. It is recognized that the Bayer pattern provides for greaterluminance detail than chrominance. It may further be recognized that thesensor has a reduced spatial resolution since a total of 4 adjacentpixels are required to produce the color information for the aggregatespatial portion of the image. In an alternative approach, the colorimage may be constructed by rapidly strobing the visualized area at highspeed with a variety of optical sources (either laser or light-emittingdiodes) having different central optical wavelengths.

The optical strobing system may be under the control of the camerasystem, and may include a specially designed CMOS sensor with high speedreadout. The principal benefit is that the sensor can accomplish thesame spatial resolution with significantly fewer pixels compared withconventional Bayer or 3-sensor cameras. Therefore, the physical spaceoccupied by the pixel array may be reduced. The actual pulse periods(2230 a-c) may differ within the repeating pattern, as illustrated inFIG. 153B. This is useful for, e.g., apportioning greater time to thecomponents that require the greater light energy or those having theweaker sources. As long as the average captured frame rate is an integermultiple of the requisite final system frame rate, the data may simplybe buffered in the signal processing chain as appropriate.

The facility to reduce the CMOS sensor chip-area to the extent allowedby combining all of these methods is particularly attractive for smalldiameter (˜3-10 mm) endoscopy. In particular, it allows for endoscopedesigns in which the sensor is located in the space-constrained distalend, thereby greatly reducing the complexity and cost of the opticalsection, while providing high definition video. A consequence of thisapproach is that to reconstruct each final, full color image, requiresthat data be fused from three separate snapshots in time. Any motionwithin the scene, relative to the optical frame of reference of theendoscope, will generally degrade the perceived resolution, since theedges of objects appear at slightly different locations within eachcaptured component. In this disclosure, a means of diminishing thisissue is described which exploits the fact that spatial resolution ismuch more important for luminance information, than for chrominance.

The basis of the approach is that, instead of firing monochromatic lightduring each frame, combinations of the three wavelengths are used toprovide all of the luminance information within a single image. Thechrominance information is derived from separate frames with, e.g., arepeating pattern such as Y-Cb-Y-Cr (FIG. 153D). While it is possible toprovide pure luminance data by a shrewd choice of pulse ratios, the sameis not true of chrominance.

In one aspect, as illustrated in FIG. 153D, an endoscopic system 2300 amay comprise a pixel array 2302 a having uniform pixels and the system2300 a may be operated to receive Y (luminance pulse) 2304 a, Cb(ChromaBlue) 2306 a and Cr (ChromaRed) 2308 a pulses.

To complete a full color image requires that the two components ofchrominance also be provided. However, the same algorithm that wasapplied for luminance cannot be directly applied for chrominance imagessince it is signed, as reflected in the fact that some of the RGBcoefficients are negative. The solution to this is to add a degree ofluminance of sufficient magnitude that all of the final pulse energiesbecome positive. As long as the color fusion process in the ISP is awareof the composition of the chrominance frames, they can be decoded bysubtracting the appropriate amount of luminance from a neighboringframe. The pulse energy proportions are given by:

Y=0.183·R+0.614·G+0.062·B

Cb=λ·Y−0.101·R−0.339·G+0.439·B

Cr=δ·Y+0.439·R−0.399·G−0.040·B

where

λ≥0.399/0.614=0.552

δ≥0.399/0.614=0.650

It turns out that if the λ factor is equal to 0.552; both the red andthe green components are exactly cancelled, in which case the Cbinformation can be provided with pure blue light. Similarly, settingδ=0.650 cancels out the blue and green components for Cr which becomespure red. This particular example is illustrated in FIG. 153E, whichalso depicts λ and δ as integer multiples of ½⁸. This is a convenientapproximation for the digital frame reconstruction.

In the case of the Y-Cb-Y-Cr pulsing scheme, the image data is alreadyin the YCbCr space following the color fusion. Therefore, in this caseit makes sense to perform luminance and chrominance based operations upfront, before converting back to linear RGB to perform the colorcorrection etc.

The color fusion process is more straightforward than de-mosaic, whichis necessitated by the Bayer pattern (see FIG. 153C), since there is nospatial interpolation. It does require buffering of frames though inorder to have all of the necessary information available for each pixel.In one general aspect, data for the Y-Cb-Y-Cr pattern may be pipelinedto yield one full color image per two raw captured images. This isaccomplished by using each chrominance sample twice. In FIG. 153F thespecific example of a 120 Hz frame capture rate providing 60 Hz finalvideo is depicted.

Additional disclosures regarding the control of the laser components ofan illumination system as depicted in FIGS. 153B-153F for use in asurgical visualization system 108 may be found in U.S. PatentApplication Publication No. 2014/0160318, titled YCBCR PULSEDILLUMINATION SCHEME IN A LIGHT DEFICIENT ENVIRONMENT, filed on Jul. 26,2013, which issued on Dec. 6, 2016 as U.S. Pat. No. 9,516,239, and U.S.Patent Application Publication No. 2014/0160319, titled CONTINUOUS VIDEOIN A LIGHT DEFICIENT ENVIRONMENT, filed on Jul. 26, 2013, which issuedon Aug. 22, 2017 as U.S. Pat. No. 9,743,016, the contents thereof beingincorporated by reference herein in their entirety and for all purposes.

Subsurface Vascular Imaging

During a surgical procedure, a surgeon may be required to manipulatetissues to effect a desired medical outcome. The actions of the surgeonare limited by what is visually observable in the surgical site. Thus,the surgeon may not be aware, for example, of the disposition ofvascular structures that underlie the tissues being manipulated duringthe procedure.

Since the surgeon is unable to visualize the vasculature beneath asurgical site, the surgeon may accidentally sever one or more criticalblood vessels during the procedure.

Therefore, it is desirable to have a surgical visualization system thatcan acquire imaging data of the surgical site for presentation to asurgeon in which the presentation can include information related to thepresence of vascular structures located beneath the surface of asurgical site.

Some aspects of the present disclosure further provide for a controlcircuit configured to control the illumination of a surgical site usingone or more illumination sources such as laser light sources and toreceive imaging data from one or more image sensors. In some aspects,the present disclosure provides for a non-transitory computer readablemedium storing computer readable instructions that, when executed, causea device to detect a blood vessel in a tissue and determine its depthbelow the surface of the tissue.

In some aspects, a surgical image acquisition system may include aplurality of illumination sources wherein each illumination source isconfigured to emit light having a specified central wavelength, a lightsensor configured to receive a portion of the light reflected from atissue sample when illuminated by the one or more of the plurality ofillumination sources, and a computing system. The computing system maybe configured to: receive data from the light sensor when the tissuesample is illuminated by each of the plurality of illumination sources;determine a depth location of a structure within the tissue sample basedon the data received by the light sensor when the tissue sample isilluminated by each of the plurality of illumination sources, andcalculate visualization data regarding the structure and the depthlocation of the structure. In some aspects, the visualization data mayhave a data format that may be used by a display system, and thestructure may comprise one or more vascular tissues.

Vascular Imaging Using NIR Spectroscopy

In one aspect, a surgical image acquisition system may include anindependent color cascade of illumination sources comprising visiblelight and light outside of the visible range to image one or moretissues within a surgical site at different times and at differentdepths. The surgical image acquisition system may further detect orcalculate characteristics of the light reflected and/or refracted fromthe surgical site. The characteristics of the light may be used toprovide a composite image of the tissue within the surgical site as wellas provide an analysis of underlying tissue not directly visible at thesurface of the surgical site. The surgical image acquisition system maydetermine tissue depth location without the need for separatemeasurement devices.

In one aspect, the characteristic of the light reflected and/orrefracted from the surgical site may be an amount of absorbance of lightat one or more wavelengths. Various chemical components of individualtissues may result in specific patterns of light absorption that arewavelength dependent.

In one aspect, the illumination sources may comprise a red laser sourceand a near infrared laser source, wherein the one or more tissues to beimaged may include vascular tissue such as veins or arteries. In someaspects, red laser sources (in the visible range) may be used to imagesome aspects of underlying vascular tissue based on spectroscopy in thevisible red range. In some non-limiting examples, a red laser lightsource may source illumination having a peak wavelength that may rangebetween 635 nm and 660 nm, inclusive. Non-limiting examples of a redlaser peak wavelength may include about 635 nm, about 640 nm, about 645nm, about 650 nm, about 655 nm, about 660 nm, or any value or range ofvalues therebetween. In some other aspects, near infrared laser sourcesmay be used to image underlying vascular tissue based on near infraredspectroscopy. In some non-limiting examples, a near infrared lasersource may emit illumination have a wavelength that may range between750-3000 nm, inclusive. Non-limiting examples of an infrared laser peakwavelength may include about 750 nm, about 1000 nm, about 1250 nm, about1500 nm, about 1750 nm, about 2000 nm, about 2250 nm, about 2500 nm,about 2750 nm, 3000 nm, or any value or range of values therebetween. Itmay be recognized that underlying vascular tissue may be probed using acombination of red and infrared spectroscopy. In some examples, vasculartissue may be probed using a red laser source having a peak wavelengthat about 660 nm and a near IR laser source having a peak wavelength atabout 750 nm or at about 850 nm.

Near infrared spectroscopy (NIRS) is a non-invasive technique thatallows determination of tissue oxygenation based on spectro-photometricquantitation of oxy- and deoxyhemoglobin within a tissue. In someaspects, NIRS can be used to image vascular tissue directly based on thedifference in illumination absorbance between the vascular tissue andnon-vascular tissue. Alternatively, vascular tissue can be indirectlyvisualized based on a difference of illumination absorbance of bloodflow in the tissue before and after the application of physiologicalinterventions, such as arterial and venous occlusions methods.

Instrumentation for near-IR (NIR) spectroscopy may be similar toinstruments for the UV-visible and mid-IR ranges. Such spectroscopicinstruments may include an illumination source, a detector, and adispersive element to select a specific near-IR wavelength forilluminating the tissue sample. In some aspects, the source may comprisean incandescent light source or a quartz halogen light source. In someaspects, the detector may comprise semiconductor (for example, anInGaAs) photodiode or photo array. In some aspects, the dispersiveelement may comprise a prism or, more commonly, a diffraction grating.Fourier transform NIR instruments using an interferometer are alsocommon, especially for wavelengths greater than about 1000 nm. Dependingon the sample, the spectrum can be measured in either reflection ortransmission mode.

FIG. 154 depicts schematically one example of instrumentation 2400similar to instruments for the UV-visible and mid-IR ranges for NIRspectroscopy. A light source 2402 may emit a broad spectral range ofillumination 2404 that may impinge upon a dispersive element 2406 (suchas a prism or a diffraction grating). The dispersive element 2406 mayoperate to select a narrow wavelength portion 2408 of the light emittedby the broad spectrum light source 2402, and the selected portion 2408of the light may illuminate the tissue 2410. The light reflected fromthe tissue 2412 may be directed to a detector 2416 (for example, bymeans of a dichroic mirror 2414) and the intensity of the reflectedlight 2412 may be recorded. The wavelength of the light illuminating thetissue 2410 may be selected by the dispersive element 2406. In someaspects, the tissue 2410 may be illuminated only by a single narrowwavelength portion 2408 selected by the dispersive element 2406 form thelight source 2402. In other aspects, the tissue 2410 may be scanned witha variety of narrow wavelength portions 2408 selected by the dispersiveelement 2406. In this manner, a spectroscopic analysis of the tissue2410 may be obtained over a range of NIR wavelengths.

FIG. 155 depicts schematically one example of instrumentation 2430 fordetermining NIRS based on Fourier transform infrared imaging. In FIG.155, a laser source emitting 2432 light in the near IR range 2434illuminates a tissue sample 2440. The light reflected 2436 by the tissue2440 is reflected 2442 by a mirror, such as a dichroic mirror 2444, to abeam splitter 2446. The beam splitter 2446 directs one portion of thelight 2448 reflected 2436 by the tissue 2440 to a stationary mirror 2450and one portion of the light 2452 reflected 2436 by the tissue 2440 amoving mirror 2454. The moving mirror 2454 may oscillate in positionbased on an affixed piezoelectric transducer activated by a sinusoidalvoltage having a voltage frequency. The position of the moving mirror2454 in space corresponds to the frequency of the sinusoidal activationvoltage of the piezoelectric transducer. The light reflected from themoving mirror and the stationary mirror may be recombined 2458 at thebeam splitter 2446 and directed to a detector 2456. Computationalcomponents may receive the signal output of the detector 2456 andperform a Fourier transform (in time) of the received signal. Becausethe wavelength of the light received from the moving mirror 2454 variesin time with respect to the wavelength of the light received from thestationary mirror 2450, the time-based Fourier transform of therecombined light corresponds to a wavelength-based Fourier transform ofthe recombined light 2458. In this manner, a wavelength-based spectrumof the light reflected from the tissue 2440 may be determined andspectral characteristics of the light reflected 2436 from the tissue2440 may be obtained. Changes in the absorbance of the illumination inspectral components from the light reflected from the tissue 2440 maythus indicate the presence or absence of tissue having specific lightabsorbing properties (such as hemoglobin).

An alternative to near infrared light to determine hemoglobinoxygenation would be the use of monochromatic red light to determine thered light absorbance characteristics of hemoglobin. The absorbancecharacteristics of red light having a central wavelength of about 660 nmby the hemoglobin may indicate if the hemoglobin is oxygenated (arterialblood) or deoxygenated (venous blood).

In some alternative surgical procedures, contrasting agents can be usedto improve the data that is collected on oxygenation and tissue oxygenconsumption. In one non-limiting example, NIRS techniques may be used inconjunction with a bolus injection of a near-IR contrast agent such asindocyanine green (ICG) which has a peak absorbance at about 800 nm. ICGhas been used in some medical procedures to measure cerebral blood flow.

Vascular Imaging Using Laser Doppler Flowmetry

In one aspect, the characteristic of the light reflected and/orrefracted from the surgical site may be a Doppler shift of the lightwavelength from its illumination source.

Laser Doppler flowmetry may be used to visualize and characterized aflow of particles moving relative to an effectively stationarybackground. Thus, laser light scattered by moving particles, such asblood cells, may have a different wavelength than that of the originalilluminating laser source. In contrast, laser light scattered by theeffectively stationary background (for example, the vascular tissue) mayhave the same wavelength of that of the original illuminating lasersource. The change in wavelength of the scattered light from the bloodcells may reflect both the direction of the flow of the blood cellsrelative to the laser source as well as the blood cell velocity. FIGS.156A-C illustrate the change in wavelength of light scattered from bloodcells that may be moving away from (FIG. 156A) or towards (FIG. 156C)the laser light source.

In each of FIGS. 156A-C, the original illuminating light 2502 isdepicted having a relative central wavelength of 0. It may be observedfrom FIG. 156A that light scattered from blood cells moving away fromthe laser source 2504 has a wavelength shifted by some amount 2506 to agreater wavelength relative to that of the laser source (and is thus redshifted). It may also be observed from FIG. 156C that light scatteredfrom blood cells moving towards from the laser source 2508 has awavelength shifted by some amount 2510 to a shorter wavelength relativeto that of the laser source (and is thus blue shifted). The amount ofwavelength shift (for example 2506 or 2510) may be dependent on thevelocity of the motion of the blood cells. In some aspects, an amount ofa red shift (2506) of some blood cells may be about the same as theamount of blue shift (2510) of some other blood cells. Alternatively, anamount of a red shift (2506) of some blood cells may differ from theamount of blue shift (2510) of some other blood cells Thus, the velocityof the blood cells flowing away from the laser source as depicted inFIG. 156A may be less than the velocity of the blood cells flowingtowards the laser source as depicted in FIG. 156C based on the relativemagnitude of the wavelength shifts (2506 and 2510). In contrast, and asdepicted in FIG. 156B, light scattered from tissue not moving relativeto the laser light source (for example blood vessels 2512 ornon-vascular tissue 2514) may not demonstrate any change in wavelength.

FIG. 157 depicts an aspect of instrumentation 2530 that may be used todetect a Doppler shift in laser light scattered from portions of atissue 2540. Light 2534 originating from a laser 2532 may pass through abeam splitter 2544. Some portion of the laser light 2536 may betransmitted by the beam splitter 2544 and may illuminate tissue 2540.Another portion of the laser light may be reflected 2546 by the beamsplitter 2544 to impinge on a detector 2550. The light back-scattered2542 by the tissue 2540 may be directed by the beam splitter 2544 andalso impinge on the detector 2550. The combination of the light 2534originating from the laser 2532 with the light back-scattered 2542 bythe tissue 2540 may result in an interference pattern detected by thedetector 2550. The interference pattern received by the detector 2550may include interference fringes resulting from the combination of thelight 2534 originating from the laser 2532 and the Doppler shifted (andthus wavelength shifted) light back-scattered 2452 from the tissue 2540.

It may be recognized that back-scattered light 2542 from the tissue 2540may also include back scattered light from boundary layers within thetissue 2540 and/or wavelength-specific light absorption by materialwithin the tissue 2540. As a result, the interference pattern observedat the detector 2550 may incorporate interference fringe features fromthese additional optical effects and may therefore confound thecalculation of the Doppler shift unless properly analyzed.

FIG. 158 depicts some of these additional optical effects. It is wellknown that light traveling through a first optical medium having a firstrefractive index, n1, may be reflected at an interface with a secondoptical medium having a second refractive index, n2. The lighttransmitted through the second optical medium will have a transmissionangle relative to the interface that differs from the angle of theincident light based on a difference between the refractive indices n1and n2 (Snell's Law). FIG. 158 illustrates the effect of Snell's Law onlight impinging on the surface of a multi-component tissue 2150, as maybe presented in a surgical field. The multi-component tissue 2150 may becomposed of an outer tissue layer 2152 having a refractive index n1 anda buried tissue, such as a blood vessel having a vessel wall 2156. Theblood vessel wall 2156 may be characterized by a refractive index n2.Blood may flow within the lumen of the blood vessel 2160. In someaspects, it may be important during a surgical procedure to determinethe position of the blood vessel 2160 below the surface 2154 of theouter tissue layer 2152 and to characterize the blood flow using Dopplershift techniques.

An incident laser light 2170 a may be used to probe for the blood vessel2160 and may be directed on the top surface 2154 of the outer tissuelayer 2152. A portion 2172 of the incident laser light 2170 a may bereflected at the top surface 2154. Another portion 2170 b of theincident laser light 2170 a may penetrate the outer tissue layer 2152.The reflected portion 2172 at the top surface 2154 of the outer tissuelayer 2152 has the same path length of the incident light 2170 a, andtherefore has the same wavelength and phase of the incident light 2170a. However, the portion 2170 b of light transmitted into the outertissue layer 2152 will have a transmission angle that differs from theincidence angle of the light impinging on the tissue surface because theouter tissue layer 2152 has an index of refraction n1 that differs fromthe index of refraction of air.

If the portion of light transmitted through the outer tissue layer 2152impinges on a second tissue surface 2158, for example of the bloodvessel wall 2156, some portion 2174 a,b of light will be reflected backtowards the source of the incident light 2170 a. The light thusreflected 2174 a at the interface between the outer tissue layer 2152and the blood vessel wall 2156 will have the same wavelength as theincident light 2170 a, but will be phase shifted due to the change inthe light path length. Projecting the light reflected 2174 a,b from theinterface between the outer tissue layer 2152 and the blood vessel wall2156 along with the incident light on the sensor, will produce aninterference pattern based on the phase difference between the two lightsources.

Further, a portion of the incident light 2170 c may be transmittedthrough the blood vessel wall 2156 and penetrate into the blood vessellumen 2160. This portion of the incident light 2170 c may interact withthe moving blood cells in the blood vessel lumen 2160 and may bereflected back 2176 a-c towards the source of the impinging light havinga wavelength Doppler shifted according to the velocity of the bloodcells, as disclosed above. The Doppler shifted light reflected 2176 a-cfrom the moving blood cells may be projected along with the incidentlight on the sensor, resulting in an interference pattern having afringe pattern based on the wavelength difference between the two lightsources.

In FIG. 158, a light path 2178 is presented of light impinging on thered blood cells in the blood vessel lumen 2160 if there are no changesin refractive index between the emitted light and the light reflected bythe moving blood cells. In this example, only a Doppler shift in thereflected light wavelength can be detected. However, the light reflectedby the blood cells (2176 a-c) may incorporate phase changes due to thevariation in the tissue refractive indices in addition to the wavelengthchanges due to the Doppler Effect.

Thus, it may be understood that if the light sensor receives theincident light, the light reflected from one or more tissue interfaces(2172, and 2174 a,b) and the Doppler shifted light from the blood cells(2176 a-c), the interference pattern thus produced on the light sensormay include the effects due to the Doppler shift (change in wavelength)as well as the effects due to the change in refractive index within thetissue (change in phase). As a result, a Doppler analysis of the lightreflected by the tissue sample may produce erroneous results if theeffects due to changes in the refractive index within the sample are notcompensated for.

FIG. 159 illustrates an example of the effects on a Doppler analysis oflight that impinge 2250 on a tissue sample to determine the depth andlocation of an underlying blood vessel. If there is no interveningtissue between the blood vessel and the tissue surface, the interferencepattern detected at the sensor may be due primarily to the change inwavelength reflected from the moving blood cells. As a result, aspectrum 2252 derived from the interference pattern may generallyreflect only the Doppler shift of the blood cells. However, if there isintervening tissue between the blood vessel and the tissue surface, theinterference pattern detected at the sensor may be due to a combinationof the change in wavelength reflected from the moving blood cells andthe phase shift due to the refractive index of the intervening tissue. Aspectrum 2254 derived from such an interference pattern, may result inthe calculation of the Doppler shift that is confounded due to theadditional phase change in the reflected light. In some aspects, ifinformation regarding the characteristics (thickness and refractiveindex) of the intervening tissue is known, the resulting spectrum 2256may be corrected to provide a more accurate calculation of the change inwavelength.

It is recognized that the tissue penetration depth of light is dependenton the wavelength of the light used. Thus, the wavelength of the lasersource light may be chosen to detect particle motion (such a bloodcells) at a specific range of tissue depth. FIGS. 160A-C depictschematically a means for detect moving particles such as blood cells ata variety of tissue depths based on the laser light wavelength. Asillustrated in FIG. 160A, a laser source 2340 may direct an incidentbeam of laser light 2342 onto a surface 2344 of a surgical site. A bloodvessel 2346 (such as a vein or artery) may be disposed within the tissue2348 at some depth δ from the tissue surface. The penetration depth 2350of a laser into a tissue 2348 may be dependent at least in part on thelaser wavelength. Thus, laser light having a wavelength in the red rangeof about 635 nm to about 660 nm, may penetrate the tissue 2351 a to adepth of about 1 mm. Laser light having a wavelength in the green rangeof about 520 nm to about 532 nm may penetrate the tissue 2351 b to adepth of about 2-3 mm. Laser light having a wavelength in the blue rangeof about 405 nm to about 445 nm may penetrate the tissue 2351 c to adepth of about 4 mm or greater. In the example depicted in FIGS. 160A-C,a blood vessel 2346 may be located at a depth δ of about 2-3 mm belowthe tissue surface. Red laser light will not penetrate to this depth andthus will not detect blood cells flowing within this vessel. However,both green and blue laser light can penetrate this depth. Therefore,scattered green and blue laser light from the blood cells within theblood vessel 2346 may demonstrate a Doppler shift in wavelength.

FIG. 160B illustrates how a Doppler shift 2355 in the wavelength ofreflected laser light may appear. The emitted light (or laser sourcelight 2342) impinging on a tissue surface 2344 may have a centralwavelength 2352. For example, light from a green laser may have acentral wavelength 2352 within a range of about 520 nm to about 532 nm.The reflected green light may have a central wavelength 2354 shifted toa longer wavelength (red shifted) if the light was reflected from aparticle such as a red blood cell that is moving away from the detector.The difference between the central wavelength 2352 of the emitted laserlight and the central wavelength 2354 of the emitted laser lightcomprises the Doppler shift 2355.

As disclosed above with respect to FIGS. 158 and 159, laser lightreflected from structures within a tissue 2348 may also show a phaseshift in the reflected light due to changes in the index of refractionarising from changes in tissue structure or composition. The emittedlight (or laser source light 2342) impinging on a tissue surface 2344may have a first phase characteristic 2356. The reflected laser lightmay have a second phase characteristic 2358. It may be recognized thatblue laser light that can penetrate tissue to a depth of about 4 mm orgreater 2351 c may encounter a greater variety of tissue structures thanred laser light (about 1 mm 2351 a) or green laser light (about 2-3 mm2351 b). Consequently, as illustrated in FIG. 160C, the phase shift 2358of reflected blue laser light may be significant at least due to thedepth of penetration.

FIG. 160D illustrates aspects of illuminating tissue by red 2360 a,green 2360 b and blue 2360 c laser light in a sequential manner. In someaspects, a tissue may be probed by red 2360 a, green 2360 b and blue2360 c laser illumination in a sequential manner. In some alternativeexamples, one or more combinations of red 2360 a, green 2360 b, and blue2360 c laser light, as depicted in FIGS. 153D-153F and disclosed above,may be used to illuminate the tissue according to a defined illuminationsequence. 30D illustrates the effect of such illumination on a CMOSimaging sensor 2362 a-d over time. Thus, at a first time t₁, the CMOSsensor 2362 a may be illuminated by the red 2360 a laser. At a secondtime t₂ the CMOS sensor 2362 b may be illuminated by the green 2360 blaser. At a third time t₃, the CMOS sensor 2362 c may be illuminated bythe blue 2360 c laser. The illumination cycle may then be repeatedstarting at a fourth time t₄ in which the CMOS sensor 2362 d may beilluminated by the red 2360 a lase again. It may be recognized thatsequential illumination of the tissue by laser illumination at differingwavelengths may permit a Doppler analysis at varying tissue depths overtime. Although red 2360 a, green 2360 b and blue 2360 c laser sourcesmay be used to illuminate the surgical site, it may be recognized thatother wavelengths outside of visible light (such as in the infrared orultraviolet regions) may be used to illuminate the surgical site forDoppler analysis.

FIG. 161 illustrates an example of a use of Doppler imaging to detectthe present of blood vessels not otherwise viewable at a surgical site2600. In FIG. 161, a surgeon may wish to excise a tumor 2602 found inthe right superior posterior lobe 2604 of a lung. Because the lungs arehighly vascular, care must be taken to identify only those blood vesselsassociate with the tumor and to seal only those vessels withoutcompromising the blood flow to the non-affected portions of the lung. InFIG. 161, the surgeon has identified the margin 2606 of the tumor 2604.The surgeon may then cut an initial dissected area 2608 in the marginregion 2606, and exposed blood vessels 2610 may be observed for cuttingand sealing. The Doppler imaging detector 2620 may be used to locate andidentify blood vessels not observable 2612 in the dissected area. Animaging system may receive data from the Doppler imaging detector 2620for analysis and display of the data obtained from the surgical site2600. In some aspects, the imaging system may include a display toillustrate the surgical site 2600 including a visible image of thesurgical site 2600 along with an image overlay of the hidden bloodvessels 2612 on the image of the surgical site 2600.

In the scenario disclosed above regarding FIG. 161, a surgeon wishes tosever blood vessels that supply oxygen and nutrients to a tumor whilesparing blood vessels associated with non-cancerous tissue.Additionally, the blood vessels may be disposed at different depths inor around the surgical site 2600. The surgeon must therefore identifythe position (depth) of the blood vessels as well as determine if theyare appropriate for resection. FIG. 162 illustrates one method foridentifying deep blood vessels based on a Doppler shift of light fromblood cells flowing therethrough. As disclosed above, red laser lighthas a penetration depth of about 1 mm and green laser light has apenetration depth of about 2-3 mm. However, a blood vessel having abelow-surface depth of 4 mm or more will be outside the penetrationdepths at these wavelengths. Blue laser light, however, can detect suchblood vessels based on their blood flow.

FIG. 162 depicts the Doppler shift of laser light reflected from a bloodvessel at a specific depth below a surgical site. The site may beilluminated by red laser light, green laser light, and blue laser light.The central wavelength 2630 of the illuminating light may be normalizedto a relative central 3631. If the blood vessel lies at a depth of 4 ormore mm below the surface of the surgical site, neither the red laserlight nor the green laser light will be reflected by the blood vessel.Consequently, the central wavelength 2632 of the reflected red light andthe central wavelength 2634 of the reflected green light will not differmuch from the central wavelength 2630 of the illuminating red light orgreen light, respectively. However, if the site is illuminated by bluelaser light, the central wavelength 2638 of the reflected blue light2636 will differ from the central wavelength 2630 of the illuminatingblue light. In some instances, the amplitude of the reflected blue light2636 may also be significantly reduced from the amplitude of theilluminating blue light. A surgeon may thus determine the presence of adeep lying blood vessel along with its approximate depth, and therebyavoiding the deep blood vessel during surface tissue dissection.

FIGS. 163 and 164 illustrates schematically the use of laser sourceshaving differing central wavelengths (colors) for determining theapproximate depth of a blood vessel beneath the surface of a surgicalsite. FIG. 163 depicts a first surgical site 2650 having a surface 2654and a blood vessel 2656 disposed below the surface 2654. In one method,the blood vessel 2656 may be identified based on a Doppler shift oflight impinging on the flow 2658 of blood cells within the blood vessel2656. The surgical site 2650 may be illuminated by light from a numberof lasers 2670, 2676, 2682, each laser being characterized by emittinglight at one of several different central wavelengths. As noted above,illumination by a red laser 2670 can only penetrate tissue by about 1mm. Thus, if the blood vessel 2656 was located at a depth of less than 1mm 2672 below the surface 2654, the red laser illumination would bereflected 2674 and a Doppler shift of the reflected red illumination2674 may be determined. Further, as noted above, illumination by a greenlaser 2676 can only penetrate tissue by about 2-3 mm. If the bloodvessel 2656 was located at a depth of about 2-3 mm 2678 below thesurface 2654, the green laser illumination would be reflected 2680 whilethe red laser illumination 2670 would not, and a Doppler shift of thereflected green illumination 2680 may be determined. However, asdepicted in FIG. 163, the blood vessel 2656 is located at a depth ofabout 4 mm 2684 below the surface 2654. Therefore, neither the red laserillumination 2670 nor the green laser illumination 2676 would bereflected. Instead, only the blue laser illumination would be reflected2686 and a Doppler shift of the reflected blue illumination 2686 may bedetermined.

In contrast to the blood vessel 2656 depicted in FIG. 163, the bloodvessel 2656′ depicted in FIG. 164 is located closer to the surface ofthe tissue at the surgical site. Blood vessel 2656′ may also bedistinguished from blood vessel 2656 in that blood vessel 2656′ isillustrated to have a much thicker wall 2657. Thus, blood vessel 2656′may be an example of an artery while blood vessel 2656 may be an exampleof a vein because arterial walls are known to be thicker than venouswalls. In some examples, arterial walls may have a thickness of about1.3 mm. As disclosed above, red laser illumination 2670′ can penetratetissue to a depth of about 1 mm 2672′. Thus, even if a blood vessel2656′ is exposed at a surgical site (see 2610 at FIG. 161), red laserlight that is reflected 2674′ from the surface of the blood vessel2656′, may not be able to visualize blood flow 2658′ within the bloodvessel 2656′ under a Doppler analysis due to the thickness of the bloodvessel wall 2657. However, as disclosed above, green laser lightimpinging 2676′ on the surface of a tissue may penetrate to a depth ofabout 2-3 mm 2678′. Further, blue laser light impinging 2682′ on thesurface of a tissue may penetrate to a depth of about 4 mm 2684′.Consequently, green laser light may be reflected 2680′ from the bloodcells flowing 2658′ within the blood vessel 2656′ and blue laser lightmay be reflected 2686′ from the blood cells flowing 2658′ within theblood vessel 2656′. As a result, a Doppler analysis of the reflectedgreen light 2680′ and reflected blue light 2686′ may provide informationregarding blood flow in near-surface blood vessel, especially theapproximate depth of the blood vessel.

As disclosed above, the depth of blood vessels below the surgical sitemay be probed based on wavelength-dependent Doppler imaging. The amountof blood flow through such a blood vessel may also be determined byspeckle contrast (interference) analysis. Doppler shift may indicate amoving particle with respect to a stationary light source. As disclosedabove, the Doppler wavelength shift may be an indication of the velocityof the particle motion. Individual particles such as blood cells may notbe separately observable. However, the velocity of each blood cell willproduce a proportional Doppler shift. An interference pattern may begenerated by the combination of the light back-scattered from multipleblood cells due to the differences in the Doppler shift of theback-scattered light from each of the blood cells. The interferencepattern may be an indication of the number density of blood cells withina visualization frame. The interference pattern may be termed specklecontrast. Speckle contrast analysis may be calculated using a full frame300×300 CMOS imaging array, and the speckle contrast may be directlyrelated to the amount of moving particles (for example blood cells)interacting with the laser light over a given exposure period.

A CMOS image sensor may be coupled to a digital signal processor (DSP).Each pixel of the sensor may be multiplexed and digitized. The Dopplershift in the light may be analyzed by looking at the source laser lightin comparison to the Doppler shifted light. A greater Doppler shift andspeckle may be related to a greater number of blood cells and theirvelocity in the blood vessel.

FIG. 165 depicts an aspect of a composite visual display 2800 that maybe presented a surgeon during a surgical procedure. The composite visualdisplay 2800 may be constructed by overlaying a white light image 2830of the surgical site with a Doppler analysis image 2850.

In some aspects, the white light image 2830 may portray the surgicalsite 2832, one or more surgical incisions 2834, and the tissue 2836readily visible within the surgical incision 2834. The white light image2830 may be generated by illuminating 2840 the surgical site 2832 with awhite light source 2838 and receiving the reflected white light 2842 byan optical detector. Although a white light source 2838 may be used toilluminate the surface of the surgical site, in one aspect, the surfaceof the surgical site may be visualized using appropriate combinations ofred 2854, green 2856, and blue 2858 laser light as disclosed above withrespect to FIGS. 153C-153F.

In some aspects, the Doppler analysis image 2850 may include bloodvessel depth information along with blood flow information 2852 (fromspeckle analysis). As disclosed above, blood vessel depth and blood flowvelocity may be obtained by illuminating the surgical site with laserlight of multiple wavelengths, and determining the blood vessel depthand blood flow based on the known penetration depth of the light of aparticular wavelength. In general, the surgical site 2832 may beilluminated by light emitted by one or more lasers such as a red leaser2854, a green laser 2856, and a blue laser 2858. A CMOS detector 2872may receive the light reflected back (2862, 2866, 2870) from thesurgical site 2832 and its surrounding tissue. The Doppler analysisimage 2850 may be constructed 2874 based on an analysis of the multiplepixel data from the CMOS detector 2872.

In one aspect, a red laser 2854 may emit red laser illumination 2860 onthe surgical site 2832 and the reflected light 2862 may reveal surfaceor minimally subsurface structures. In one aspect, a green laser 2856may emit green laser illumination 2864 on the surgical site 2832 and thereflected light 2866 may reveal deeper subsurface characteristics. Inanother aspect, a blue laser 2858 may emit blue laser illumination 2868on the surgical site 2832 and the reflected light 2870 may reveal, forexample, blood flow within deeper vascular structures. In addition, thespeckle contrast analysis my present the surgeon with informationregarding the amount and velocity of blood flow through the deepervascular structures.

Although not depicted in FIG. 165, it may be understood that the imagingsystem may also illuminate the surgical site with light outside of thevisible range. Such light may include infrared light and ultravioletlight. In some aspects, sources of the infrared light or ultravioletlight may include broad-band wavelength sources (such as a tungstensource, a tungsten-halogen source, or a deuterium source). In some otheraspects, the sources of the infrared or ultraviolet light may includenarrow-band wavelength sources (IR diode lasers, UV gas lasers or dyelasers).

FIG. 166 is a flow chart 2900 of a method for determining a depth of asurface feature in a piece of tissue. An image acquisition system mayilluminate 2910 a tissue with a first light beam having a first centralfrequency and receive 2912 a first reflected light from the tissueilluminated by the first light beam. The image acquisition system maythen calculate 2914 a first Doppler shift based on the first light beamand the first reflected light. The image acquisition system may thenilluminate 2916 the tissue with a second light beam having a secondcentral frequency and receive 2918 a second reflected light from thetissue illuminated by the second light beam. The image acquisitionsystem may then calculate 2920 a second Doppler shift based on thesecond light beam and the second reflected light. The image acquisitionsystem may then calculate 2922 a depth of a tissue feature based atleast in part on the first central wavelength, the first Doppler shift,the second central wavelength, and the second Doppler shift. In someaspects, the tissue features may include the presence of movingparticles, such as blood cells moving within a blood vessel, and adirection and velocity of flow of the moving particles. It may beunderstood that the method may be extended to include illumination ofthe tissue by any one or more additional light beams. Further, thesystem may calculate an image comprising a combination of an image ofthe tissue surface and an image of the structure disposed within thetissue.

In some aspects, multiple visual displays may be used. For example, a 3Ddisplay may provide a composite image displaying the combined whitelight (or an appropriate combination of red, green, and blue laserlight) and laser Doppler image. Additional displays may provide only thewhite light display or a displaying showing a composite white lightdisplay and an NIRS display to visualize only the blood oxygenationresponse of the tissue. However, the NIRS display may not be requiredevery cycle allowing for response of tissue.

Subsurface Tissue Characterization Using Multispectral OCT

During a surgical procedure, the surgeon may employ “smart” surgicaldevices for the manipulation of tissue. Such devices may be considered“smart” in that they include automated features to direct, control,and/or vary the actions of the devices based parameters relevant totheir uses. The parameters may include the type and/or composition ofthe tissue being manipulated. If the type and/or composition of thetissue being manipulated is unknown, the actions of the smart devicesmay be inappropriate for the tissue being manipulated. As a result,tissues may be damaged or the manipulation of the tissue may beineffective due to inappropriate settings of the smart device.

The surgeon may manually attempt to vary the parameters of the smartdevice in a trial-and-error manner, resulting in an inefficient andlengthy surgical procedure.

Therefore, it is desirable to have a surgical visualization system thatcan probe tissue structures underlying a surgical site to determinetheir structural and compositional characteristics, and to provide suchdata to smart surgical instruments being used in a surgical procedure.

Some aspects of the present disclosure further provide for a controlcircuit configured to control the illumination of a surgical site usingone or more illumination sources such as laser light sources and toreceive imaging data from one or more image sensors. In some aspects,the present disclosure provides for a non-transitory computer readablemedium storing computer readable instructions that, when executed, causea device to characterize structures below the surface at a surgical siteand determine the depth of the structures below the surface of thetissue.

In some aspects, a surgical image acquisition system may comprise aplurality of illumination sources wherein each illumination source isconfigured to emit light having a specified central wavelength, a lightsensor configured to receive a portion of the light reflected from atissue sample when illuminated by the one or more of the plurality ofillumination sources, and a computing system. The computing system maybe configured to receive data from the light sensor when the tissuesample is illuminated by each of the plurality of illumination sources,calculate structural data related to a characteristic of a structurewithin the tissue sample based on the data received by the light sensorwhen the tissue sample is illuminated by each of the illuminationsources, and transmit the structural data related to the characteristicof the structure to be received by a smart surgical device. In someaspects, the characteristic of the structure is a surface characteristicor a structure composition.

In one aspect, a surgical system may include multiple laser lightsources and may receive laser light reflected from a tissue. The lightreflected from the tissue may be used by the system to calculate surfacecharacteristics of components disposed within the tissue. Thecharacteristics of the components disposed within the tissue may includea composition of the components and/or a metric related to surfaceirregularities of the components.

In one aspect, the surgical system may transmit data related to thecomposition of the components and/or metrics related to surfaceirregularities of the components to a second instrument to be used onthe tissue to modify the control parameters of the second instrument.

In some aspects, the second device may be an advanced energy device andthe modifications of the control parameters may include a clamppressure, an operational power level, an operational frequency, and atransducer signal amplitude.

As disclosed above, blood vessels may be detected under the surface of asurgical site base on the Doppler shift in light reflected by the bloodcells moving within the blood vessels.

Laser Doppler flowmetry may be used to visualize and characterized aflow of particles moving relative to an effectively stationarybackground. Thus, laser light scattered by moving particles, such asblood cells, may have a different wavelength than that of the originalilluminating laser source. In contrast, laser light scattered by theeffectively stationary background (for example, the vascular tissue) mayhave the same wavelength of that of the original illuminating lasersource. The change in wavelength of the scattered light from the bloodcells may reflect both the direction of the flow of the blood cellsrelative to the laser source as well as the blood cell velocity. Aspreviously disclosed, FIGS. 156A-C illustrate the change in wavelengthof light scattered from blood cells that may be moving away from (FIG.156A) or towards (FIG. 156C) the laser light source.

In each of FIGS. 156A-C, the original illuminating light 2502 isdepicted having a relative central wavelength of 0. It may be observedfrom FIG. 156A that light scattered from blood cells moving away fromthe laser source 2504 has a wavelength shifted by some amount 2506 to agreater wavelength relative to that of the laser source (and is thus redshifted). It may also be observed from FIG. 154C that light scatteredfrom blood cells moving towards from the laser source 2508 has awavelength shifted by some amount 2510 to a shorter wavelength relativeto that of the laser source (and is thus blue shifted). The amount ofwavelength shift (for example 2506 or 2510) may be dependent on thevelocity of the motion of the blood cells. In some aspects, an amount ofa red shift (2506) of some blood cells may be about the same as theamount of blue shift (2510) of some other blood cells. Alternatively, anamount of a red shift (2506) of some blood cells may differ from theamount of blue shift (2510) of some other blood cells Thus, the velocityof the blood cells flowing away from the laser source as depicted inFIG. 154A may be less than the velocity of the blood cells flowingtowards the laser source as depicted in FIG. 156C based on the relativemagnitude of the wavelength shifts (2506 and 2510). In contrast, and asdepicted in FIG. 156B, light scattered from tissue not moving relativeto the laser light source (for example blood vessels 2512 ornon-vascular tissue 2514) may not demonstrate any change in wavelength.

As previously disclosed, FIG. 157 depicts an aspect of instrumentation2530 that may be used to detect a Doppler shift in laser light scatteredfrom portions of a tissue 2540. Light 2534 originating from a laser 2532may pass through a beam splitter 2544. Some portion of the laser light2536 may be transmitted by the beam splitter 2544 and may illuminatetissue 2540. Another portion of the laser light may be reflected 2546 bythe beam splitter 2544 to impinge on a detector 2550. The lightback-scattered 2542 by the tissue 2540 may be directed by the beamsplitter 2544 and also impinge on the detector 2550. The combination ofthe light 2534 originating from the laser 2532 with the lightback-scattered 2542 by the tissue 2540 may result in an interferencepattern detected by the detector 2550. The interference pattern receivedby the detector 2550 may include interference fringes resulting from thecombination of the light 2534 originating from the laser 2532 and theDoppler shifted (and thus wavelength shifted) light back-scattered 2452from the tissue 2540.

It may be recognized that back-scattered light 2542 from the tissue 2540may also include back scattered light from boundary layers within thetissue 2540 and/or wavelength-specific light absorption by materialwithin the tissue 2540. As a result, the interference pattern observedat the detector 2550 may incorporate interference fringe features fromthese additional optical effects and may therefore confound thecalculation of the Doppler shift unless properly analyzed.

It may be recognized that light reflected from the tissue may alsoinclude back scattered light from boundary layers within the tissueand/or wavelength-specific light absorption by material within thetissue. As a result, the interference pattern observed at the detectormay incorporate fringe features that may confound the calculation of theDoppler shift unless properly analyzed.

As previously disclosed, FIG. 158 depicts some of these additionaloptical effects. It is well known that light traveling through a firstoptical medium having a first refractive index, n1, may be reflected atan interface with a second optical medium having a second refractiveindex, n2. The light transmitted through the second optical medium willhave a transmission angle relative to the interface that differs fromthe angle of the incident light based on a difference between therefractive indices n1 and n2 (Snell's Law). FIG. 156 illustrates theeffect of Snell's Law on light impinging on the surface of amulti-component tissue 2150, as may be presented in a surgical field.The multi-component tissue 2150 may be composed of an outer tissue layer2152 having a refractive index n1 and a buried tissue, such as a bloodvessel having a vessel wall 2156. The blood vessel wall 2156 may becharacterized by a refractive index n2. Blood may flow within the lumenof the blood vessel 2160. In some aspects, it may be important during asurgical procedure to determine the position of the blood vessel 2160below the surface 2154 of the outer tissue layer 2152 and tocharacterize the blood flow using Doppler shift techniques.

An incident laser light 2170 a may be used to probe for the blood vessel2160 and may be directed on the top surface 2154 of the outer tissuelayer 2152. A portion 2172 of the incident laser light 2170 a may bereflected at the top surface 2154. Another portion 2170 b of theincident laser light 2170 a may penetrate the outer tissue layer 2152.The reflected portion 2172 at the top surface 2154 of the outer tissuelayer 2152 has the same path length of the incident light 2170 a, andtherefore has the same wavelength and phase of the incident light 2170a. However, the portion 2170 b of light transmitted into the outertissue layer 2152 will have a transmission angle that differs from theincidence angle of the light impinging on the tissue surface because theouter tissue layer 2152 has an index of refraction n1 that differs fromthe index of refraction of air.

If the portion of light transmitted through the outer tissue layer 2152impinges on a second tissue surface 2158, for example of the bloodvessel wall 2156, some portion 2174 a,b of light will be reflected backtowards the source of the incident light 2170 a. The light thusreflected 2174 a at the interface between the outer tissue layer 2152and the blood vessel wall 2156 will have the same wavelength as theincident light 2170 a, but will be phase shifted due to the change inthe light path length. Projecting the light reflected 2174 a,b from theinterface between the outer tissue layer 2152 and the blood vessel wall2156 along with the incident light on the sensor, will produce aninterference pattern based on the phase difference between the two lightsources.

Further, a portion of the incident light 2170 c may be transmittedthrough the blood vessel wall 2156 and penetrate into the blood vessellumen 2160. This portion of the incident light 2170 c may interact withthe moving blood cells in the blood vessel lumen 2160 and may bereflected back 2176 a-c towards the source of the impinging light havinga wavelength Doppler shifted according to the velocity of the bloodcells, as disclosed above. The Doppler shifted light reflected 2176 a-cfrom the moving blood cells may be projected along with the incidentlight on the sensor, resulting in an interference pattern having afringe pattern based on the wavelength difference between the two lightsources.

In FIG. 158, a light path 2178 is presented of light impinging on thered blood cells in the blood vessel lumen 2160 if there are no changesin refractive index between the emitted light and the light reflected bythe moving blood cells. In this example, only a Doppler shift in thereflected light wavelength can be detected. However, the light reflectedby the blood cells (2176 a-c) may incorporate phase changes due to thevariation in the tissue refractive indices in addition to the wavelengthchanges due to the Doppler Effect.

Thus, it may be understood that if the light sensor receives theincident light, the light reflected from one or more tissue interfaces(2172, and 2174 a,b) and the Doppler shifted light from the blood cells(2176 a-c), the interference pattern thus produced on the light sensormay include the effects due to the Doppler shift (change in wavelength)as well as the effects due to the change in refractive index within thetissue (change in phase). As a result, a Doppler analysis of the lightreflected by the tissue sample may produce erroneous results if theeffects due to changes in the refractive index within the sample are notcompensated for.

As previously disclosed, FIG. 159 illustrates an example of the effectson a Doppler analysis of light that impinge 2250 on a tissue sample todetermine the depth and location of an underlying blood vessel. If thereis no intervening tissue between the blood vessel and the tissuesurface, the interference pattern detected at the sensor may be dueprimarily to the change in wavelength reflected from the moving bloodcells. As a result, a spectrum 2252 derived from the interferencepattern may generally reflect only the Doppler shift of the blood cells.However, if there is intervening tissue between the blood vessel and thetissue surface, the interference pattern detected at the sensor may bedue to a combination of the change in wavelength reflected from themoving blood cells and the phase shift due to the refractive index ofthe intervening tissue. A spectrum 2254 derived from such aninterference pattern, may result in the calculation of the Doppler shiftthat is confounded due to the additional phase change in the reflectedlight. In some aspects, if information regarding the characteristics(thickness and refractive index) of the intervening tissue is known, theresulting spectrum 2256 may be corrected to provide a more accuratecalculation of the change in wavelength.

It may be recognized that the phase shift in the reflected light from atissue may provide additional information regarding underlying tissuestructures, regardless of Doppler effects.

FIG. 167 illustrates that the location and characteristics ofnon-vascular structures may be determined based on the phase differencebetween the incident light 2372 and the light reflected from the deeptissue structures (2374, 2376, 2378). As noted above, the penetrationdepth of light impinging on a tissue is dependent on the wavelength ofthe impinging illumination. Red laser light (having a wavelength in therange of about 635 nm to about 660 nm) may penetrate the tissue to adepth of about 1 mm. Green laser light (having a wavelength in the rangeof about 520 nm to about 532 nm) may penetrate the tissue to a depth ofabout 2-3 mm. Blue laser light (having a wavelength in the range ofabout 405 nm to about 445 nm) may penetrate the tissue to a depth ofabout 4 mm or greater. In one aspect, an interface 2381 a between twotissues differing in refractive index that is located less than or about1 mm below a tissue surface 2380 may reflect 2374 red, green, or bluelaser light. The phase of the reflected light 2374 may be compared tothe incident light 2372 and thus the difference in the refractive indexof the tissues at the interface 2381 a may be determined. In anotheraspect, an interface 2381 b between two tissues differing in refractiveindex that is located between 2 and 3 mm 2381 b below a tissue surface2380 may reflect 2376 green or blue laser light, but not red light. Thephase of the reflected light 2376 may be compared to the incident light2372 and thus the difference in the refractive index of the tissues atthe interface 2381 b may be determined. In yet another aspect, aninterface 2381 c between two tissues differing in refractive index thatis located between 3 and 4 mm 2381 c below a tissue surface 2380 mayreflect 2378 only blue laser light, but not red or green light. Thephase of the reflected light 2378 may be compared to the incident light2372 and thus the difference in the refractive index of the tissues atthe interface 2381 c may be determined.

A phase interference measure of a tissue illuminated by light havingdifferent wavelengths may therefore provide information regarding therelative indices of refraction of the reflecting tissue as well as thedepth of the tissue. The indices of refraction of the tissue may beassessed using the multiple laser sources and their intensity, andthereby relative indices of refraction may be calculated for the tissue.It is recognized that different tissues may have different refractiveindices. For example, the refractive index may be related to therelative composition of collagen and elastin in a tissue or the amountof hydration of the tissue. Therefore, a technique to measure relativetissue index of refraction may result in the identification of acomposition of the tissue.

In some aspects, smart surgical instruments include algorithms todetermine parameters associated with the function of the instruments.One non-limiting example of such parameters may be the pressure of ananvil against a tissue for a smart stapling device. The amount ofpressure of an anvil against a tissue may depend on the type andcomposition of the tissue. For example, less pressure may be required tostaple a highly compressive tissue, while a greater amount of pressuremay be required to stable a more non-compressive tissue. Anothernon-limiting example of a parameter associated with a smart surgicaldevice may include a rate of firing of an i-beam knife to cut thetissue. For example, a stiff tissue may require more force and a slowercutting rate than a less stiff tissue. Another non-limiting example ofsuch parameters may be the amount of current provided to an electrode ina smart cauterizing or RF sealing device. Tissue composition, such aspercent tissue hydration, may determine an amount of current necessaryto heat seal the tissue. Yet another non-limiting example of suchparameters may be the amount of power provided to an ultrasonictransducer of a smart ultrasound cutting device or the driving frequencyof the cutting device. A stiff tissue may require more power forcutting, and contact of the ultrasonic cutting tool with a stiff tissuemay shift the resonance frequency of the cutter.

It may be recognized that a tissue visualization system that canidentify tissue type and depth may provide such data to one or moresmart surgical devices. The identification and location data may then beused by the smart surgical devices to adjust one or more of theiroperating parameters thereby allowing them to optimize theirmanipulation of the tissue. It may be understood that an optical methodto characterize a type of tissue may permit automation of the operatingparameters of the smart surgical devices. Such automation of theoperation of smart surgical instruments may be preferable to relying onhuman estimation to determine the operational parameters of theinstruments.

In one aspect, Optical Coherence Tomography (OCT) is a technique thatcan visual subsurface tissue structures based on the phase differencebetween an illuminating light source, and light reflected fromstructures located within the tissue. FIG. 168 depicts schematically oneexample of instrumentation 2470 for Optical Coherence Tomography. InFIG. 168, a laser source 2472 may emit light 2482 according to anyoptical wavelength of interest (red, green, blue, infrared, orultraviolet). The light 2482 may be directed to a beam splitter 2486.The beam splitter 2486 directs one portion of the light 2488 to a tissuesample 2480. The beam splitter 2486 may also direct a portion of thelight 2492 to a stationary reference mirror 2494. The light reflectedfrom the tissue sample 2480 and from the stationary mirror 2494 may berecombined 2498 at the beam splitter 2486 and directed to a detector2496. The phase difference between the light from the reference mirror2494 and from the tissue sample 2480 may be detected at the detector2496 as an interference pattern. Appropriate computing devices may thencalculate phase information from the interference pattern. Additionalcomputation may then provide information regarding structures below thesurface of the tissue sample. Additional depth information may also beobtained by comparing the interference patterns generated from thesample when illuminated at different wavelengths of laser light.

As disclosed above, depth information regarding subsurface tissuestructures may be ascertained from a combination of laser lightwavelength and the phase of light reflected from a deep tissuestructure. Additionally, local tissue surface inhomogeneity may beascertained by comparing the phase as well as amplitude difference oflight reflected from different portions of the same sub-surface tissues.Measurements of a difference in the tissue surface properties at adefined location compared to those at a neighboring location may beindicative of adhesions, disorganization of the tissue layers,infection, or a neoplasm in the tissue being probed.

FIG. 169 illustrates this effect. The surface characteristics of atissue determine the angle of reflection of light impinging on thesurface. A smooth surface 2551 a reflects the light essentially with thesame spread 2544 as the light impinging on the surface 2542 (specularreflection). Consequently, the amount of light received by a lightdetector having a known fixed aperture may effectively receive theentire amount of light reflected 2544 from the smooth surface 2551 a.However, increased surface roughness at a tissue surface may result inan increase spread in the reflected light with respect to the incidentlight (diffuse reflection).

Some amount of the reflected light 2546 from a tissue surface havingsome amount of surface irregularities 2551 b will fall outside the fixedaperture of the light detector due to the increased spread of thereflected light 2546. As a result, the light detector will detect lesslight (shown in FIG. 169 as a decrease in the amplitude of the reflectedlight signal 2546). It may be understood that the amount of reflectedlight spread will increase as the surface roughness of a tissueincreases. Thus, as depicted in FIG. 169, the amplitude of lightreflected 2548 from a surface 2551 c having significant surfaceroughness may have a smaller amplitude than the light reflected 2544from a smooth surface 2551 a, or light reflected 2546 form a surfacehaving only a moderate amount of surface roughness 2551 b. Therefore, insome aspects, a single laser source may be used to investigate thequality of a tissue surface or subsurface by comparing the opticalproperties of reflected light from the tissue with the opticalproperties of reflected light from adjacent surfaces.

In other aspects, light from multiple laser sources (for example, lasersemitting light having different central wavelengths) may be usedsequentially to probe tissue surface characteristics at a variety ofdepths below the surface 2550. As disclosed above (with reference toFIG. 167), the absorbance profile of a laser light in a tissue isdependent on the central wavelength of the laser light. Laser lighthaving a shorter (more blue) central wavelength can penetrate tissuedeeper than laser light having a longer (more red) central wavelength.Therefore, measurements related to light diffuse reflection made atdifferent light wavelengths can indicate both an amount of surfaceroughness as well as the depth of the surface being measured.

FIG. 170 illustrates one method of displaying image processing datarelated to a combination of tissue visualization modalities. Data usedin the display may be derived from image phase data related to tissuelayer composition, image intensity (amplitude) data related to tissuesurface features, and image wavelength data related to tissue mobility(such as blood cell transport) as well as tissue depth. As one example,light emitted by a laser in the blue optical region 2562 may impinge onblood flowing at a depth of about 4 mm below the surface of the tissue.The reflected light 2564 may be red shifted due to the Doppler effect ofthe blood flow. As a result, information may be obtained regarding theexistence of a blood vessel and its depth below the surface.

In another example, a layer of tissue may lie at a depth of about 2-3 mmbelow the surface of the surgical site. This tissue may include surfaceirregularities indicative of scarring or other pathologies. Emitted redlight 2572 may not penetrate to the 2-3 mm depth, so consequently, thereflected red light 2580 may have about the same amplitude of theemitted red light 2572 because it is unable to probe structures morethan 1 mm below the top surface of the surgical site. However, greenlight reflected from the tissue 2578 may reveal the existence of thesurface irregularities at that depth in that the amplitude of thereflected green light 2578 may be less than the amplitude of the emittedgreen light 2570. Similarly, blue light reflected from the tissue 2574may reveal the existence of the surface irregularities at that depth inthat the amplitude of the reflected blue light 2574 may be less than theamplitude of the emitted blue light 2562. In one example of an imageprocessing step, the image 2582 may be smoothed using a moving windowfilter 2584 to reduce inter-pixel noise as well as reduce small localtissue anomalies 2586 that may hide more important features 2588.

FIGS. 171A-C illustrate several aspects of displays that may be providedto a surgeon for a visual identification of surface and sub-surfacestructures of a tissue in a surgical site. FIG. 171A may represent asurface map of the surgical site with color coding to indicatestructures located at varying depths below the surface of the surgicalsite. FIG. 171B depicts an example of one of several horizontal slicesthrough the tissue at varying depths, which may be color coded toindicate depth and further include data associated with differences intissue surface anomalies (for example, as displayed in a 3D bar graph).FIG. 171C depicts yet another visual display in which surfaceirregularities as well as Doppler shift flowmetry data may indicatesub-surface vascular structures as well as tissue surfacecharacteristics.

FIG. 172 is a flow chart 2950 of a method for providing informationrelated to a characteristic of a tissue to a smart surgical instrument.An image acquisition system may illuminate 2960 a tissue with a firstlight beam having a first central frequency and receive 2962 a firstreflected light from the tissue illuminated by the first light beam. Theimage acquisition system may then calculate 2964 a first tissue surfacecharacteristic at a first depth based on the first emitted light beamand the first reflected light from the tissue. The image acquisitionsystem may then illuminate 2966 the tissue with a second light beamhaving a second central frequency and receive 2968 a second reflectedlight from the tissue illuminated by the second light beam. The imageacquisition system may then calculate 2970 a second tissue surfacecharacteristic at a second depth based on the second emitted light beamand the second reflected light from the tissue. Tissue features that mayinclude a tissue type, a tissue composition, and a tissue surfaceroughness metric may be determined from the first central lightfrequency, the second central light frequency, the first reflected lightfrom the tissue, and the second reflected light from the tissue. Thetissue characteristic may be used to calculate 2972 one or moreparameters related to the function of a smart surgical instrument suchas jaw pressure, power to effect tissue cauterization, or currentamplitude and/or frequency to drive a piezoelectric actuator to cut atissue. In some additional examples, the parameter may be transmitted2974 either directly or indirectly to the smart surgical instrumentwhich may modify its operating characteristics in response to the tissuebeing manipulated.

Multifocal Minimally Invasive Camera

In a minimally invasive procedure, e.g., laparoscopic, a surgeon mayvisualize the surgical site using imaging instruments including a lightsource and a camera. The imaging instruments may allow the surgeon tovisualize the end effector of a surgical device during the procedure.However, the surgeon may need to visualize tissue away from the endeffector to prevent unintended damage during the surgery. Such distanttissue may lie outside the field of view of the camera system whenfocused on the end effector. The imaging instrument may be moved inorder to change the field of view of the camera, but it may be difficultto return the camera system back to its original position after beingmoved.

The surgeon may attempt to move the imaging system within the surgicalsite to visualize different portions of the site during the procedure.Repositioning of the imaging system is time consuming and the surgeon isnot guaranteed to visualize the same field of view of the surgical sitewhen the imaging system is returned to its original location.

It is therefore desirable to have a medical imaging visualization systemthat can provide multiple fields of view of the surgical site withoutthe need to reposition the visualization system. Medical imaging devicesinclude, without limitation, laparoscopes, endoscopes, thoracoscopes,and the like, as described herein. In some aspects, a single displaysystem may display each of the multiple fields of view of the surgicalsite at about the same time. The display of each of the multiple fieldsof view may be independently updated depending on a display controlsystem composed of one or more hardware modules, one or more softwaremodules, one or more firmware modules, or any combination orcombinations thereof.

Some aspects of the present disclosure further provide for a controlcircuit configured to control the illumination of a surgical site usingone or more illumination sources such as laser light sources and toreceive imaging data from one or more image sensors. In some aspects,the control circuit may be configured to control the operation of one ormore light sensor modules to adjust a field of view. In some aspects,the present disclosure provides for a non-transitory computer readablemedium storing computer readable instructions that, when executed, causea device to adjust one or more components of the one or more lightsensor modules and to process an image from each of the one or morelight sensor modules.

An aspect of a minimally invasive image acquisition system may comprisea plurality of illumination sources wherein each illumination source isconfigured to emit light having a specified central wavelength, a firstlight sensing element having a first field of view and configured toreceive illumination reflected from a first portion of the surgical sitewhen the first portion of the surgical site is illuminated by at leastone of the plurality of illumination sources, a second light sensingelement having a second field of view and configured to receiveillumination reflected from a second portion of the surgical site whenthe second portion of the surgical site is illuminated by at least oneof the plurality of illumination sources, wherein the second field ofview overlaps at least a portion of the first field of view; and acomputing system.

The computing system may be configured to receive data from the firstlight sensing element, receive data from the second light sensingelement, compute imaging data based on the data received from the firstlight sensing element and the data received from the second lightsensing element, and transmit the imaging data for receipt by a displaysystem.

A variety of surgical visualization systems have been disclosed above.Such systems provide for visualizing tissue and sub-tissue structuresthat may be encountered during one or more surgical procedures.Non-limiting examples of such systems may include: systems to determinethe location and depth of subsurface vascular tissue such as veins andarteries; systems to determine an amount of blood flowing through thesubsurface vascular tissue; systems to determine the depth ofnon-vascular tissue structures; systems to characterize the compositionof such non-vascular tissue structures; and systems to characterize oneor more surface characteristics of such tissue structures.

It may be recognized that a single surgical visualization system mayincorporate components of any one or more of these visualizationmodalities. FIGS. 152A-D depict some examples of such a surgicalvisualization system 2108.

As disclosed above, in one non-limiting aspect, a surgical visualizationsystem 2108 may include an imaging control unit 2002 and a hand unit2020. The hand unit 2020 may include a body 2021, a camera scope cable2015 attached to the body 2021, and an elongated camera probe 2024. Theelongated camera probe 2024 may also terminate at its distal end with atleast one window. In some non-limiting examples, a light sensor 2030 maybe incorporated in the hand unit 2020, for example either in the body ofthe hand unit 2032 b, or at a distal end 2032 a of the elongated cameraprobe, as depicted in FIG. 152C. The light sensor 2030 may be fabricatedusing a CMOS sensor array or a CCD sensor array. As illustrated in FIG.153C, a typical CMOS or CCD sensor array may generate an RGB(red-green-blue) image from light impinging on a mosaic of sensorelements, each sensor element having one of a red, green, or blueoptical filter.

Alternatively, the illumination of the surgical site may be cycled amongvisible illumination sources as depicted in FIG. 160D. In some example,the illumination sources may include any one or more of a red laser 2360a, a green laser 2360 b, or a blue laser 2360 c. In some non-limitingexamples, a red laser 2360 a light source may source illumination havinga peak wavelength that may range between 635 nm and 660 nm, inclusive.Non-limiting examples of a red laser peak wavelength may include about635 nm, about 640 nm, about 645 nm, about 650 nm, about 655 nm, about660 nm, or any value or range of values therebetween. In somenon-limiting examples, a green laser 2360 b light source may sourceillumination having a peak wavelength that may range between 520 nm and532 nm, inclusive. Non-limiting examples of a red laser peak wavelengthmay include about 520 nm, about 522 nm, about 524 nm, about 526 nm,about 528 nm, about 530 nm, about 532 nm, or any value or range ofvalues therebetween. In some non-limiting examples, the blue laser 2360c light source may source illumination having a peak wavelength that mayrange between 405 nm and 445 nm, inclusive. Non-limiting examples of ablue laser peak wavelength may include about 405 nm, about 410 nm, about415 nm, about 420 nm, about 425 nm, about 430 nm, about 435 nm, about440 nm, about 445 nm, or any value or range of values therebetween.

Additionally, illumination of the surgical site may be cycled to includenon-visible illumination sources that may supply infrared or ultravioletillumination. In some non-limiting examples, an infrared laser lightsource may source illumination having a peak wavelength that may rangebetween 750 nm and 3000 nm, inclusive. Non-limiting examples of aninfrared laser peak wavelength may include about 750 nm, about 1000 nm,about 1250 nm, about 1500 nm, about 1750 nm, about 2000 nm, about 2250nm, about 2500 nm, about 2750 nm, 3000 nm, or any value or range ofvalues therebetween. In some non-limiting examples, an ultraviolet laserlight source may source illumination having a peak wavelength that mayrange between 200 nm and 360 nm, inclusive. Non-limiting examples of anultraviolet laser peak wavelength may include about 200 nm, about 220nm, about 240 nm, about 260 nm, about 280 nm, about 300 nm, about 320nm, about 340 nm, about 360 nm, or any value or range of valuestherebetween.

The outputs of the sensor array under the different illuminationwavelengths may be combined to form the RGB image, for example, if theillumination cycle time is sufficiently fast and the laser light is inthe visible range. FIGS. 173A and 173B illustrate a multi-pixel lightsensor receiving by light reflected by a tissue illuminated, forexample, by sequential exposure to red, green, blue, infrared, (FIG.173A) or red, green, blue, and ultraviolet laser light sources (FIG.173B).

FIG. 174A depicts the distal end of a flexible elongated camera probe2120 having a flexible camera probe shaft 2122 and a single light sensormodule 2124 disposed at the distal end 2123 of the flexible camera probeshaft 2122. In some non-limiting examples, the flexible camera probeshaft 2122 may have an outer diameter of about 5 mm. The outer diameterof the flexible camera probe shaft 2122 may depend on geometric factorsthat may include, without limitation, the amount of allowable bend inthe shaft at the distal end 2123. As depicted in FIG. 174A, the distalend 2123 of the flexible camera probe shaft 2122 may bend about 90° withrespect to a longitudinal axis of an un-bent portion of the flexiblecamera probe shaft 2122 located at a proximal end of the elongatedcamera probe 2120. It may be recognized that the distal end 2123 of theflexible camera probe shaft 2122 may bend any appropriate amount as maybe required for its function. Thus, as non-limiting examples, the distalend 2123 of the flexible camera probe shaft 2122 may bend any amountbetween about 0° and about 90°. Non-limiting examples of the bend angleof the distal end 2123 of the flexible camera probe shaft 2122 mayinclude about 0°, about 10°, about 20°, about 30°, about 40°, about 50°,about 60°, about 70°, about 80°, about 90°, or any value or range ofvalues therebetween. In some examples, the bend angle of the distal end2123 of the flexible camera probe shaft 2122 may be set by a surgeon orother health care professional prior to or during a surgical procedure.In some other example, the bend angle of the distal end 2123 of theflexible camera probe shaft 2122 may be a fixed angle set at amanufacturing site.

The single light sensor module 2124 may receive light reflected from thetissue when illuminated by light emitted by one or more illuminationsources 2126 disposed at the distal end of the elongated camera probe.In some examples, the light sensor module 2124 may be a 4 mm sensormodule such as 4 mm mount 2136 b, as depicted in FIG. 152D. It may berecognized that the light sensor module 2124 may have any appropriatesize for its intended function. Thus, the light sensor module 2124 mayinclude a 5.5 mm mount 2136 a, a 2.7 mm mount 2136 c, or a 2 mm mount2136 d as depicted in FIG. 152D.

It may be recognized that the one or more illumination sources 2126 mayinclude any number of illumination sources 2126 including, withoutlimitation, one illumination source, two illumination sources, threeillumination sources, four illumination sources, or more than fourillumination sources. It may be further understood that eachillumination source may source illumination having any centralwavelength including a central red illumination wavelength, a centralgreen illumination wavelength, a central blue illumination wavelength, acentral infrared illumination wavelength, a central ultravioletillumination wavelength, or any other wavelength. In some examples, theone or more illumination sources 2126 may include a white light source,which may illuminate tissue with light having wavelengths that may spanthe range of optical white light from about 390 nm to about 700 nm.

FIG. 174B depicts the distal end 2133 of an alternative elongated cameraprobe 2130 having multiple light sensor modules, for example the twolight sensor modules 2134 a,b, each disposed at the distal end 2133 ofthe elongated camera probe 2130. In some non-limiting examples, thealternative elongated camera probe 2130 may have an outer diameter ofabout 7 mm. In some examples, the light sensor modules 2134 a,b may eachcomprise a 4 mm sensor module, similar to light sensor module 2124 inFIG. 174A. Alternatively, each of the light sensor modules 2134 a,b maycomprise a 5.5 mm light sensor module, a 2.7 mm light sensor module, ora 2 mm light sensor module as depicted in FIG. 152D. In some examples,both light sensor modules 2134 a,b may have the same size. In someexamples, the light sensor modules 2134 a,b may have different sizes. Asone non-limiting example, an alternative elongated camera probe 2130 mayhave a first 4 mm light sensor and two additional 2 mm light sensors. Insome aspects, a visualization system may combine the optical outputsfrom the multiple light sensor modules 2134 a,b to form a 3D or quasi-3Dimage of the surgical site. In some other aspects, the outputs of themultiple light sensor modules 2134 a,b may be combined in such a manneras to enhance the optical resolution of the surgical site, which may notbe otherwise practical with only a single light sensor module.

Each of the multiple light sensor modules 2134 a,b may receive lightreflected from the tissue when illuminated by light emitted by one ormore illumination sources 2136 a,b disposed at the distal end 2133 ofthe alternative elongated camera probe 2130. In some non-limitingexamples, the light emitted by all of the illumination sources 2136 a,bmay be derived from the same light source (such as a laser). In othernon-limiting examples, the illumination sources 2136 a surrounding afirst light sensor module 2134 a may emit light at a first wavelengthand the illumination sources 2136 b surrounding a second light sensormodule 2134 b may emit light at a second wavelength. It may be furtherunderstood that each illumination source 2136 a,b may sourceillumination having any central wavelength including a central redillumination wavelength, a central green illumination wavelength, acentral blue illumination wavelength, a central infrared illuminationwavelength, a central ultraviolet illumination wavelength, or any otherwavelength. In some examples, the one or more illumination sources 2136a,b may include a white light source, which may illuminate tissue withlight having wavelengths that may span the range of optical white lightfrom about 390 nm to about 700 nm.

In some additional aspects, the distal end 2133 of the alternativeelongated camera probe 2130 may include one or more working channels2138. Such working channels 2138 may be in fluid communication with anaspiration port of a device to aspirate material from the surgical site,thereby permitting the removal of material that may potentially obscurethe field of view of the light sensor modules 2134 a,b. Alternatively,such working channels 2138 may be in fluid communication with an fluidsource port of a device to provide a fluid to the surgical site, toflush debris or material away from the surgical site. Such fluids may beused to clear material from the field of view of the light sensormodules 2134 a,b.

FIG. 174C depicts a perspective view of an aspect of a monolithic sensor2160 having a plurality of pixel arrays for producing a threedimensional image in accordance with the teachings and principles of thedisclosure. Such an implementation may be desirable for threedimensional image capture, wherein the two pixel arrays 2162 and 2164may be offset during use. In another implementation, a first pixel array2162 and a second pixel array 2164 may be dedicated to receiving apredetermined range of wave lengths of electromagnetic radiation,wherein the first pixel array 2162 is dedicated to a different range ofwave length electromagnetic radiation than the second pixel array 2164.

Additional disclosures regarding a dual sensor array may be found inU.S. Patent Application Publication No. 2014/0267655, titled SUPERRESOLUTION AND COLOR MOTION ARTIFACT CORRECTION IN A PULSED COLORIMAGING SYSTEM, filed on Mar. 14, 2014, which issued on May 2, 2017 asU.S. Pat. No. 9,641,815, the contents thereof being incorporated byreference herein in its entirety and for all purposes.

In some aspects, a light sensor module may comprise a multi-pixel lightsensor such as a CMOS array in addition to one or more additionaloptical elements such as a lens, a reticle, and a filter.

In some alternative aspects, the one or more light sensors may belocated within the body 2021 of the hand unit 2020. Light reflected fromthe tissue may be acquired at a light receiving surface of one or moreoptical fibers at the distal end of the elongated camera probe 2024. Theone or more optical fibers may conduct the light from the distal end ofthe elongated camera probe 2024 to the one or more light sensors, or toadditional optical elements housed in the body of the hand unit 2020 orin the imaging control unit 2002. The additional optical elements mayinclude, without limitation, one or more dichroic mirrors, one or morereference mirrors, one or more moving mirrors, and one or more beamsplitters and/or combiners, and one or more optical shutters. In suchalternative aspects, the light sensor module may include any one or moreof a lens, a reticle and a filter, disposed at the distal end of theelongated camera probe 2024.

Images obtained from each of the multiple light sensors for example 2134a,b may be combined or processed in several different manners, either incombination or separately, and then displayed in a manner to allow asurgeon to visualize different aspects of the surgical site.

In one non-limiting example, each light sensor may have an independentfield of view. In some additional examples, the field of view of a firstlight sensor may partially or completely overlap the field of view of asecond light sensor.

As disclosed above, an imaging system may include a hand unit 2020having an elongated camera probe 2024 with one or more light sensormodules 2124, 2134 a,b disposed at its distal end 2123, 2133. As anexample, the elongated camera probe 2024 may have two light sensormodules 2134 a,b, although it may be recognized that there may be three,four, five, or more light sensor modules at the distal end of theelongated camera probe 2024. Although FIGS. 175 and 176A-D depictexamples of the distal end of an elongated camera probe having two lightsensor modules, it may be recognized that the description of theoperation of the light sensor modules is not limited to solely two lightsensor modules. As depicted in FIG. 175, and 46A-D, the light sensormodules may include an image sensor, such as a CCD or CMOS sensor thatmay be composed of an array of light sensing elements (pixels). Thelight sensor modules may also include additional optical elements, suchas lenses. Each lens may be adapted to provide a field of view for thelight sensor of the respective light sensor module.

FIG. 175 depicts a generalized view of a distal end 2143 of an elongatedcamera probe having multiple light sensor modules 2144 a,b. Each lightsensor module 2144 a,b may be composed of a CCD or CMOS sensor and oneor more optical elements such as filters, lenses, shutters, and similar.In some aspects, the components of the light sensor modules 2144 a,b maybe fixed within the elongated camera probe. In some other aspects, oneor more of the components of the light sensor modules 2144 a,b may beadjustable. For example, the CCD or CMOS sensor of a light sensor module2144 a,b may be mounted on a movable mount to permit automatedadjustment of the center 2145 a,b of a field of view 2147 a,b of the CCDor CMOS sensor. In some other aspects, the CCD or CMOS sensor may befixed, but a lens in each light sensor modules 2144 a,b may beadjustable to change the focus. In some aspects, the light sensormodules 2144 a,b may include adjustable irises to permit changes in thevisual aperture of the sensor modules 2144 a,b.

As depicted in FIG. 175, each of the sensor modules 2144 a,b may have afield of view 2147 a,b having an acceptance angle. As depicted in FIG.175, the acceptance angle for each sensor modules 2144 a,b may have anacceptance angle of greater than 90°. In some examples, the acceptanceangle may be about 100°. In some examples, the acceptance angle may beabout 120°. In some examples, if the sensor modules 2144 a,b have anacceptance angle of greater than 90° (for example, 100°), the fields ofview 2147 a and 2147 b may form an overlap region 2150 a,b. In someaspects, an optical field of view having an acceptance angle of 100° orgreater may be called a “fish-eyed” field of view. A visualizationsystem control system associated with such an elongated camera probe mayinclude computer readable instructions that may permit the display ofthe overlap region 2150 a,b in such a manner so that the extremecurvature of the overlapping fish-eyed fields of view is corrected, anda sharpened and flattened image may be displayed. In FIG. 175, theoverlap region 2150 a may represent a region wherein the overlappingfields of view 2147 a,b of the sensor modules 2144 a,b have theirrespective centers 2145 a,b directed in a forward direction. However, ifany one or more components of the sensor modules 2144 a,b is adjustable,it may be recognized that the overlap region 2150 b may be directed toany attainable angle within the fields of view 2147 a,b of the sensormodules 2144 a,b.

FIGS. 176A-D depict a variety of examples of an elongated light probehaving two light sensor modules 2144 a,b with a variety of fields ofview. The elongated light probe may be directed to visualize a surface2152 of a surgical site.

In FIG. 176A, the first light sensor module 2144 a has a first sensorfield of view 2147 a of a tissue surface 2154 a, and the second lightsensor module 2144 b has a second sensor field of view 2147 b of atissue surface 2154 b. As depicted in FIG. 176A, the first field of view2147 a and the second field of view 2147 b have approximately the sameangle of view. Additionally, the first sensor field of view 2147 a isadjacent to but does not overlap the second sensor field of view 2147 b.The image received by the first light sensor module 2144 a may bedisplayed separately from the image received by the second light sensormodule 2144 b, or the images may be combined to form a single image. Insome non-limiting examples, the angle of view of a lens associated withthe first light sensor module 2144 a and the angle of view of a lensassociated with the second light sensor module 2144 b may be somewhatnarrow, and image distortion may not be great at the periphery of theirrespective images. Therefore, the images may be easily combined edge toedge.

As depicted in FIG. 176B, the first field of view 2147 a and the secondfield of view 2147 b have approximately the same angular field of view,and the first sensor field of view 2147 a overlaps completely the secondsensor field of view 2147 b. This may result in a first sensor field ofview 2147 a of a tissue surface 2154 a being identical to the view of atissue surface 2154 b as obtained by the second light sensor module 2144b from the second sensor field 2147 b of view. This configuration may beuseful for applications in which the image from the first light sensormodule 2144 a may be processed differently than the image from thesecond light sensor module 2144 b. The information in the first imagemay complement the information in the second image and refer to the sameportion of tissue.

As depicted in FIG. 176C, the first field of view 2147 a and the secondfield of view 2147 b have approximately the same angular field of view,and the first sensor field of view 2147 a partially overlaps the secondsensor field of view 2147 b. In some non-limiting examples, a lensassociated with the first light sensor module 2144 a and a lensassociated with the second light sensor module 2144 b may be wide anglelenses. These lenses may permit the visualization of a wider field ofview than that depicted in FIG. 176A. Wide angle lenses are known tohave significant optical distortion at their periphery. Appropriateimage processing of the images obtained by the first light sensor module2144 a and the second light sensor module 2144 b may permit theformation of a combined image in which the central portion of thecombined image is corrected for any distortion induced by either thefirst lens or the second lens. It may be understood that a portion ofthe first sensor field of view 2147 a of a tissue surface 2154 a maythus have some distortion due to the wide angle nature of a lensassociated with the first light sensor module 2144 a and a portion ofthe second sensor field of view 2147 b of a tissue surface 2154 b maythus have some distortion due to the wide angle nature of a lensassociated with the second light sensor module 2144 b. However, aportion of the tissue viewed in the overlap region 2150′ of the twolight sensor modules 2144 a,b may be corrected for any distortioninduced by either of the light sensor modules 2144 a,b. Theconfiguration depicted in FIG. 176C may be useful for applications inwhich it is desired to have a wide field of view of the tissue around aportion of a surgical instrument during a surgical procedure. In someexamples, lenses associated with each light sensor module 2144 a,b maybe independently controllable, thereby controlling the location of theoverlap region 2150′ of view within the combined image.

As depicted in FIG. 176D, the first light sensor module 2144 a may havea first angular field of view 2147 a that is wider than the secondangular field of view 2147 b of the second light sensor module 2144 b.In some non-limiting examples, the second sensor field of view 2147 bmay be totally disposed within the first sensor field of view 2147 a. Inalternative examples, the second sensor field of view may lie outside ofor tangent to the wide angle field of view 2147 a of the first sensor2144 a. A display system that may use the configuration depicted in FIG.176D may display a wide angle portion of tissue 2154 a imaged by thefirst sensor module 2144 a along with a magnified second portion oftissue 2154 b imaged by the second sensor module 2144 b and located inan overlap region 2150″ of the first field of view 2147 a and the secondfield of view 2147 b. This configuration may be useful to present asurgeon with a close-up image of tissue proximate to a surgicalinstrument (for example, imbedded in the second portion of tissue 2154b) and a wide-field image of the tissue surrounding the immediatevicinity of the medical instrument (for example, the proximal firstportion of tissue 2154 a). In some non-limiting examples, the imagepresented by the narrower second field of view 2147 b of the secondlight sensor module 2144 b may be a surface image of the surgical site.In some additional examples, the image presented in the first wide fieldview 2147 a of the first light sensor module 2144 a may include adisplay based on a hyperspectral analysis of the tissue visualized inthe wide field view.

FIGS. 177A-C illustrate an example of the use of an imaging systemincorporating the features disclosed in FIG. 176D. FIG. 177A illustratesschematically a proximal view 2170 at the distal end of the elongatedcamera probe depicting the light sensor arrays 2172 a,b of the two lightsensor modules 2174 a,b. A first light sensor module 2174 a may includea wide angle lens, and the second light sensor module 2174 b may includea narrow angle lens. In some aspects, the second light sensor module2174 b may have a narrow aperture lens. In other aspects, the secondlight sensor module 2174 b may have a magnifying lens. The tissue may beilluminated by the illumination sources disposed at the distal end ofthe elongated camera probe. The light sensor arrays 2172′ (either lightsensor array 2172 a or 2172 b, or both 2172 a and 2172 b) may receivethe light reflected from the tissue upon illumination. The tissue may beilluminated by light from a red laser source, a green laser source, ablue laser source, an infrared laser source, and/or an ultraviolet lasersource. In some aspects, the light sensor arrays 2172′ may sequentiallyreceive the red laser light 2175 a, green laser light 2175 b, blue laserlight 2175 c, infrared laser light 2175 d, and the ultra-violet laserlight 2175 e. The tissue may be illuminated by any combination of suchlaser sources simultaneously, as depicted in FIGS. 153E and 153F.Alternatively, the illuminating light may be cycled among anycombination of such laser sources, as depicted for example in FIG. 153D,and FIGS. 173A and 173B.

FIG. 177B schematically depicts a portion of lung tissue 2180 which maycontain a tumor 2182. The tumor 2182 may be in communication with bloodvessels including one or more veins 2184 and/or arteries 2186. In somesurgical procedures, the blood vessels (veins 2184 and arteries 2186)associated with the tumor 2182 may require resection and/orcauterization prior to the removal of the tumor.

FIG. 177C illustrates the use of a dual imaging system as disclosedabove with respect to FIG. 177A. The first light sensor module 2174 amay acquire a wide angle image of the tissue surrounding a blood vessel2187 to be severed with a surgical knife 2190. The wide angle image maypermit the surgeon to verify the blood vessel to be severed 2187. Inaddition, the second light sensor module 2174 b may acquire a narrowangle image of the specific blood vessel 2187 to be manipulated. Thenarrow angle image may show the surgeon the progress of the manipulationof the blood vessel 2187. In this manner, the surgeon is presented withthe image of the vascular tissue to be manipulated as well as itsenvirons to assure that the correct blood vessel is being manipulated.

FIGS. 178A and 178B depict another example of the use of a dual imagingsystem. FIG. 178A depicts a primary surgical display providing an imageof a section of a surgical site. The primary surgical display may depicta wide view image 2800 of a section of intestine 2802 along with itsvasculature 2804. The wide view image 2800 may include a portion of thesurgical field 2809 that may be separately displayed as a magnified view2810 in a secondary surgical display (FIG. 178B). As disclosed abovewith respect to surgery to remove a tumor from a lung (FIGS. 177A-C), itmay be necessary to dissect blood vessels supplying a tumor 2806 beforeremoving the cancerous tissue. The vasculature 2804 supplying theintestines 2802 is complex and highly ramified. It may necessary todetermine which blood vessels supply the tumor 2806 and to identifyblood vessels supplying blood to healthy intestinal tissue. The wideview image 2800 permits a surgeon to determine which blood vessel maysupply the tumor 2806. The surgeon may then test a blood vessel using aclamping device 2812 to determine if the blood vessel supplies the tumor2806 or not.

FIG. 178B depicts a secondary surgical display that may only display anarrow magnified view image 2810 of one portion of the surgical field2809. The narrow magnified view image 2810 may present a close-up viewof the vascular tree 2814 so that the surgeon can focus on dissectingonly the blood vessel of interest 2815. For resecting the blood vesselof interest 2815, a surgeon may use a smart RF cautery device 2816. Itmay be understood that any image obtained by the visualization systemmay include not only images of the tissue in the surgical site but alsoimages of the surgical instruments inserted therein. In some aspects,such a surgical display (either the primary display in FIG. 178A or thesecondary display in FIG. 178B) may also include indicia 2817 related tofunctions or settings of any surgical device used during the surgicalprocedure. For example, the indicia 2817 may include a power setting ofthe smart RF cautery device 2816. In some aspects, such smart medicaldevices may transmit data related to their operating parameters to thevisualization system to incorporate in display data to be transmitted toone or more display devices.

FIGS. 179A-C illustrate examples of a sequence of surgical steps for theremoval of an intestinal/colon tumor and which may benefit from the useof multi-image analysis at the surgical site. FIG. 179A depicts aportion of the surgical site, including the intestines 2932 and theramified vasculature 2934 supplying blood and nutrients to theintestines 2932. The intestines 2932 may have a tumor 2936 surrounded bya tumor margin 2937. A first light sensor module of a visualizationsystem may have a wide field of view 2930, and it may provide imagingdata of the wide field of view 2930 to a display system. A second lightsensor module of the visualization system may have a narrow or standardfield of view 2940, and it may provide imaging data of the narrow fieldof view 2940 to the display system. In some aspects, the wide fieldimage and the narrow field image may be displayed by the same displaydevice. In another aspect, the wide field image and the narrow fieldimage may be displayed by separate display devices.

During the surgical procedure, it my be important to remove not just thetumor 2936 but the margin 2937 surrounding it to assure complete removalof the tumor. A wide angle field of view 2930 may be used to image boththe vasculature 2934 as well as the section of the intestines 2932surrounding the tumor 2936 and the margin 2637. As noted above, thevasculature feeding the tumor 2936 and the margin 2637 should beremoved, but the vasculature feeding the surrounding intestinal tissuemust be preserved to provide oxygen and nutrients to the surroundingtissue. Transection of the vasculature feeding the surrounding colontissue will remove oxygen and nutrients from the tissue, leading tonecrosis. In some examples, laser Doppler imaging of the tissuevisualized in the wide angle field 2630 may be analyzed to provide aspeckle contrast analysis 2933, indicating the blood flow within theintestinal tissue.

FIG. 179B illustrates a step during the surgical procedure. The surgeonmay be uncertain which part of the vascular tree supplies blood to thetumor 2936. The surgeon may test a blood vessel 2944 to determine if itfeeds the tumor 2936 or the healthy tissue. The surgeon may clamp ablood vessel 2944 with a clamping device 2812 and determine the sectionof the intestinal tissue 2943 that is no longer perfused by means of thespeckle contrast analysis. The narrow field of view 2940 displayed on animaging device may assist the surgeon in the close-up and detailed workrequired to visualize the single blood vessel 2944 to be tested. Whenthe suspected blood vessel 2944 is clamped, a portion of the intestinaltissue 2943 is determined to lack perfusion based on the Doppler imagingspeckle contras analysis. As depicted in FIG. 159B, the suspected bloodvessel 2944 does not supply blood to the tumor 2935 or the tumor margin2937, and therefore is recognized as a blood vessel to be spared duringthe surgical procedure.

FIG. 179C depicts a following stage of the surgical procedure. In stage,a supply blood vessel 2984 has been identified to supply blood to themargin 2937 of the tumor. When this supply blood vessel 2984 has beensevered, blood is no longer supplied to a section of the intestine 2987that may include at least a portion of the margin 2937 of the tumor2936. In some aspects, the lack of perfusion to the section 2987 of theintestines may be determined by means of a speckle contrast analysisbased on a Doppler analysis of blood flow into the intestines. Thenon-perfused section 2987 of the intestines may then be isolated by aseal 2985 applied to the intestine. In this manner, only those bloodvessels perfusing the tissue indicated for surgical removal may beidentified and sealed, thereby sparing healthy tissue from unintendedsurgical consequences.

In some additional aspects, a surgical visualization system may permitimaging analysis of the surgical site.

In some aspects, the surgical site may be inspected for theeffectiveness of surgical manipulation of a tissue. Non-limitingexamples of such inspection may include the inspection of surgicalstaples or welds used to seal tissue at a surgical site. Cone beamcoherent tomography using one or more illumination sources may be usedfor such methods.

In some additional aspects, an image of a surgical site may havelandmarks denoted in the image. In some examples, the landmarks may bedetermined through image analysis techniques. In some alternativeexamples, the landmarks may be denoted through a manual intervention ofthe image by the surgeon.

In some additional aspects, non-smart ready visualizations methods maybe imported for used in Hub image fusion techniques.

In additional aspects, instruments that are not integrated in the Hubsystem may be identified and tracked during their use within thesurgical site. In this aspect, computational and/or storage componentsof the Hub or in any of its components (including, for example, in thecloud system) may include a database of images related to EES andcompetitive surgical instruments that are identifiable from one or moreimages acquired through any image acquisition system or through visualanalytics of such alternative instruments. The imaging analysis of suchdevices may further permit identification of when an instrument isreplaced with a different instrument to do the same or a similar job.The identification of the replacement of an instrument during a surgicalprocedure may provide information related to when an instrument is notdoing the job or a failure of the device.

Cloud System Hardware and Functional Modules

Aspects of the present disclosure include a cloud-based medicalanalytics system that communicatively couples to multiple Hub systems,as described above, and multiple robotic surgical devices, describedmore below. The cloud-based medical analytics system is configured toreceive data pertaining to a patient and/or medical procedure andprovide various integrated processes that span multiple Hub systems andmultiple robotic surgical devices. The cloud-based medical analyticssystem generally aggregates data and forms insights based on theaggregated data that may not otherwise be concluded without gatheringthe various disparate data sources that span the multiple Hub systemsand robotic devices. Described below are various examples of differenttypes of functions and structures present in the cloud-based medicalanalytics system that provide more detail toward these ends.

FIG. 180 is a block diagram of the computer-implemented interactivesurgical system, in accordance with at least one aspect of the presentdisclosure. In one aspect, the computer-implemented interactive surgicalsystem is configured to monitor and analyze data related to theoperation of various surgical systems that include surgical hubs,surgical instruments, robotic devices and operating theaters orhealthcare facilities. The computer-implemented interactive surgicalsystem comprises a cloud-based analytics system. Although thecloud-based analytics system is described as a surgical system, it isnot necessarily limited as such and could be a cloud-based medicalsystem generally. As illustrated in FIG. 180, the cloud-based analyticssystem comprises a plurality of surgical instruments 7012 (may be thesame or similar to instruments 112), a plurality of surgical hubs 7006(may be the same or similar to hubs 106), and a surgical data network7001 (may be the same or similar to network 201) to couple the surgicalhubs 7006 to the cloud 7004 (may be the same or similar to cloud 204).Each of the plurality of surgical hubs 7006 is communicatively coupledto one or more surgical instruments 7012. The hubs 7006 are alsocommunicatively coupled to the cloud 7004 of the computer-implementedinteractive surgical system via the network 7001. The cloud 7004 is aremote centralized source of hardware and software for storing,manipulating, and communicating data generated based on the operation ofvarious surgical systems. As shown in FIG. 180, access to the cloud 7004is achieved via the network 7001, which may be the Internet or someother suitable computer network. Surgical hubs 7006 that are coupled tothe cloud 7004 can be considered the client side of the cloud computingsystem (i.e., cloud-based analytics system). Surgical instruments 7012are paired with the surgical hubs 7006 for control and implementation ofvarious surgical procedures or operations as described herein.

In addition, surgical instruments 7012 may comprise transceivers fordata transmission to and from their corresponding surgical hubs 7006(which may also comprise transceivers). Combinations of surgicalinstruments 7012 and corresponding hubs 7006 may indicate particularlocations, such as operating theaters in healthcare facilities (e.g.,hospitals), for providing medical operations. For example, the memory ofa surgical hub 7006 may store location data. As shown in FIG. 180, thecloud 7004 comprises central servers 7013 (may be same or similar toremote server 7013), hub application servers 7002, data analyticsmodules 7034, and an input/output (“I/O”) interface 7006. The centralservers 7013 of the cloud 7004 collectively administer the cloudcomputing system, which includes monitoring requests by client surgicalhubs 7006 and managing the processing capacity of the cloud 7004 forexecuting the requests. Each of the central servers 7013 comprises oneor more processors 7008 coupled to suitable memory devices 7010 whichcan include volatile memory such as random-access memory (RAM) andnon-volatile memory such as magnetic storage devices. The memory devices7010 may comprise machine executable instructions that when executedcause the processors 7008 to execute the data analytics modules 7034 forthe cloud-based data analysis, operations, recommendations and otheroperations described below. Moreover, the processors 7008 can executethe data analytics modules 7034 independently or in conjunction with hubapplications independently executed by the hubs 7006. The centralservers 7013 also comprise aggregated medical data databases 2212, whichcan reside in the memory 2210.

Based on connections to various surgical hubs 7006 via the network 7001,the cloud 7004 can aggregate data from specific data generated byvarious surgical instruments 7012 and their corresponding hubs 7006.Such aggregated data may be stored within the aggregated medicaldatabases 7012 of the cloud 7004. In particular, the cloud 7004 mayadvantageously perform data analysis and operations on the aggregateddata to yield insights and/or perform functions that individual hubs7006 could not achieve on their own. To this end, as shown in FIG. 180,the cloud 7004 and the surgical hubs 7006 are communicatively coupled totransmit and receive information. The I/O interface 7006 is connected tothe plurality of surgical hubs 7006 via the network 7001. In this way,the I/O interface 7006 can be configured to transfer information betweenthe surgical hubs 7006 and the aggregated medical data databases 7011.Accordingly, the I/O interface 7006 may facilitate read/write operationsof the cloud-based analytics system. Such read/write operations may beexecuted in response to requests from hubs 7006. These requests could betransmitted to the hubs 7006 through the hub applications. The I/Ointerface 7006 may include one or more high speed data ports, which mayinclude universal serial bus (USB) ports, IEEE 1394 ports, as well asWi-Fi and Bluetooth I/O interfaces for connecting the cloud 7004 to hubs7006. The hub application servers 7002 of the cloud 7004 are configuredto host and supply shared capabilities to software applications (e.g.,hub applications) executed by surgical hubs 7006. For example, the hubapplication servers 7002 may manage requests made by the hubapplications through the hubs 7006, control access to the aggregatedmedical data databases 7011, and perform load balancing. The dataanalytics modules 7034 are described in further detail with reference toFIG. 181.

The particular cloud computing system configuration described in thepresent disclosure is specifically designed to address various issuesarising in the context of medical operations and procedures performedusing medical devices, such as the surgical instruments 7012, 112. Inparticular, the surgical instruments 7012 may be digital surgicaldevices configured to interact with the cloud 7004 for implementingtechniques to improve the performance of surgical operations. Varioussurgical instruments 7012 and/or surgical hubs 7006 may comprise touchcontrolled user interfaces such that clinicians may control aspects ofinteraction between the surgical instruments 7012 and the cloud 7004.Other suitable user interfaces for control such as auditory controlleduser interfaces can also be used.

FIG. 181 is a block diagram which illustrates the functionalarchitecture of the computer-implemented interactive surgical system, inaccordance with at least one aspect of the present disclosure. Thecloud-based analytics system includes a plurality of data analyticsmodules 7034 that may be executed by the processors 7008 of the cloud7004 for providing data analytic solutions to problems specificallyarising in the medical field. As shown in FIG. 181, the functions of thecloud-based data analytics modules 7034 may be assisted via hubapplications 7014 hosted by the hub application servers 7002 that may beaccessed on surgical hubs 7006. The cloud processors 7008 and hubapplications 7014 may operate in conjunction to execute the dataanalytics modules 7034. Application program interfaces (APIs) 7016define the set of protocols and routines corresponding to the hubapplications 7014. Additionally, the APIs 7016 manage the storing andretrieval of data into and from the aggregated medical databases 7012for the operations of the applications 7014. The caches 7018 also storedata (e.g., temporarily) and are coupled to the APIs 7016 for moreefficient retrieval of data used by the applications 7014. The dataanalytics modules 7034 in FIG. 181 include modules for resourceoptimization 7020, data collection and aggregation 7022, authorizationand security 7024, control program updating 7026, patient outcomeanalysis 7028, recommendations 7030, and data sorting and prioritization7032. Other suitable data analytics modules could also be implemented bythe cloud 7004, according to some aspects. In one aspect, the dataanalytics modules are used for specific recommendations based onanalyzing trends, outcomes, and other data.

For example, the data collection and aggregation module 7022 could beused to generate self-describing data (e.g., metadata) includingidentification of notable features or configuration (e.g., trends),management of redundant data sets, and storage of the data in paireddata sets which can be grouped by surgery but not necessarily keyed toactual surgical dates and surgeons. In particular, pair data setsgenerated from operations of surgical instruments 7012 can compriseapplying a binary classification, e.g., a bleeding or a non-bleedingevent. More generally, the binary classification may be characterized aseither a desirable event (e.g., a successful surgical procedure) or anundesirable event (e.g., a misfired or misused surgical instrument7012). The aggregated self-describing data may correspond to individualdata received from various groups or subgroups of surgical hubs 7006.Accordingly, the data collection and aggregation module 7022 cangenerate aggregated metadata or other organized data based on raw datareceived from the surgical hubs 7006. To this end, the processors 7008can be operationally coupled to the hub applications 7014 and aggregatedmedical data databases 7011 for executing the data analytics modules7034. The data collection and aggregation module 7022 may store theaggregated organized data into the aggregated medical data databases2212.

The resource optimization module 7020 can be configured to analyze thisaggregated data to determine an optimal usage of resources for aparticular or group of healthcare facilities. For example, the resourceoptimization module 7020 may determine an optimal order point ofsurgical stapling instruments 7012 for a group of healthcare facilitiesbased on corresponding predicted demand of such instruments 7012. Theresource optimization module 7020 might also assess the resource usageor other operational configurations of various healthcare facilities todetermine whether resource usage could be improved. Similarly, therecommendations module 7030 can be configured to analyze aggregatedorganized data from the data collection and aggregation module 7022 toprovide recommendations. For example, the recommendations module 7030could recommend to healthcare facilities (e.g., medical serviceproviders such as hospitals) that a particular surgical instrument 7012should be upgraded to an improved version based on a higher thanexpected error rate, for example. Additionally, the recommendationsmodule 7030 and/or resource optimization module 7020 could recommendbetter supply chain parameters such as product reorder points andprovide suggestions of different surgical instrument 7012, uses thereof,or procedure steps to improve surgical outcomes. The healthcarefacilities can receive such recommendations via corresponding surgicalhubs 7006. More specific recommendations regarding parameters orconfigurations of various surgical instruments 7012 can also beprovided. Hubs 7006 and/or surgical instruments 7012 each could alsohave display screens that display data or recommendations provided bythe cloud 7004.

The patient outcome analysis module 7028 can analyze surgical outcomesassociated with currently used operational parameters of surgicalinstruments 7012. The patient outcome analysis module 7028 may alsoanalyze and assess other potential operational parameters. In thisconnection, the recommendations module 7030 could recommend using theseother potential operational parameters based on yielding better surgicaloutcomes, such as better sealing or less bleeding. For example, therecommendations module 7030 could transmit recommendations to a surgical7006 regarding when to use a particular cartridge for a correspondingstapling surgical instrument 7012. Thus, the cloud-based analyticssystem, while controlling for common variables, may be configured toanalyze the large collection of raw data and to provide centralizedrecommendations over multiple healthcare facilities (advantageouslydetermined based on aggregated data). For example, the cloud-basedanalytics system could analyze, evaluate, and/or aggregate data based ontype of medical practice, type of patient, number of patients,geographic similarity between medical providers, which medicalproviders/facilities use similar types of instruments, etc., in a waythat no single healthcare facility alone would be able to analyzeindependently. The control program updating module 7026 could beconfigured to implement various surgical instrument 7012 recommendationswhen corresponding control programs are updated. For example, thepatient outcome analysis module 7028 could identify correlations linkingspecific control parameters with successful (or unsuccessful) results.Such correlations may be addressed when updated control programs aretransmitted to surgical instruments 7012 via the control programupdating module 7026. Updates to instruments 7012 that are transmittedvia a corresponding hub 7006 may incorporate aggregated performance datathat was gathered and analyzed by the data collection and aggregationmodule 7022 of the cloud 7004. Additionally, the patient outcomeanalysis module 7028 and recommendations module 7030 could identifyimproved methods of using instruments 7012 based on aggregatedperformance data.

The cloud-based analytics system may include security featuresimplemented by the cloud 7004. These security features may be managed bythe authorization and security module 7024. Each surgical hub 7006 canhave associated unique credentials such as username, password, and othersuitable security credentials. These credentials could be stored in thememory 7010 and be associated with a permitted cloud access level. Forexample, based on providing accurate credentials, a surgical hub 7006may be granted access to communicate with the cloud to a predeterminedextent (e.g., may only engage in transmitting or receiving certaindefined types of information). To this end, the aggregated medical datadatabases 7011 of the cloud 7004 may comprise a database of authorizedcredentials for verifying the accuracy of provided credentials.Different credentials may be associated with varying levels ofpermission for interaction with the cloud 7004, such as a predeterminedaccess level for receiving the data analytics generated by the cloud7004. Furthermore, for security purposes, the cloud could maintain adatabase of hubs 7006, instruments 7012, and other devices that maycomprise a “black list” of prohibited devices. In particular, a surgicalhubs 7006 listed on the black list may not be permitted to interact withthe cloud, while surgical instruments 7012 listed on the black list maynot have functional access to a corresponding hub 7006 and/or may beprevented from fully functioning when paired to its corresponding hub7006. Additionally or alternatively, the cloud 7004 may flag instruments7012 based on incompatibility or other specified criteria. In thismanner, counterfeit medical devices and improper reuse of such devicesthroughout the cloud-based analytics system can be identified andaddressed.

The surgical instruments 7012 may use wireless transceivers to transmitwireless signals that may represent, for example, authorizationcredentials for access to corresponding hubs 7006 and the cloud 7004.Wired transceivers may also be used to transmit signals. Suchauthorization credentials can be stored in the respective memory devicesof the surgical instruments 7012. The authorization and security module7024 can determine whether the authorization credentials are accurate orcounterfeit. The authorization and security module 7024 may alsodynamically generate authorization credentials for enhanced security.The credentials could also be encrypted, such as by using hash basedencryption. Upon transmitting proper authorization, the surgicalinstruments 7012 may transmit a signal to the corresponding hubs 7006and ultimately the cloud 7004 to indicate that the instruments 7012 areready to obtain and transmit medical data. In response, the cloud 7004may transition into a state enabled for receiving medical data forstorage into the aggregated medical data databases 7011. This datatransmission readiness could be indicated by a light indicator on theinstruments 7012, for example. The cloud 7004 can also transmit signalsto surgical instruments 7012 for updating their associated controlprograms. The cloud 7004 can transmit signals that are directed to aparticular class of surgical instruments 7012 (e.g., electrosurgicalinstruments) so that software updates to control programs are onlytransmitted to the appropriate surgical instruments 7012. Moreover, thecloud 7004 could be used to implement system wide solutions to addresslocal or global problems based on selective data transmission andauthorization credentials. For example, if a group of surgicalinstruments 7012 are identified as having a common manufacturing defect,the cloud 7004 may change the authorization credentials corresponding tothis group to implement an operational lockout of the group.

The cloud-based analytics system may allow for monitoring multiplehealthcare facilities (e.g., medical facilities like hospitals) todetermine improved practices and recommend changes (via therecommendations module 2030, for example) accordingly. Thus, theprocessors 7008 of the cloud 7004 can analyze data associated with anindividual healthcare facility to identify the facility and aggregatethe data with other data associated with other healthcare facilities ina group. Groups could be defined based on similar operating practices orgeographical location, for example. In this way, the cloud 7004 mayprovide healthcare facility group wide analysis and recommendations. Thecloud-based analytics system could also be used for enhanced situationalawareness. For example, the processors 7008 may predictively model theeffects of recommendations on the cost and effectiveness for aparticular facility (relative to overall operations and/or variousmedical procedures). The cost and effectiveness associated with thatparticular facility can also be compared to a corresponding local regionof other facilities or any other comparable facilities.

The data sorting and prioritization module 7032 may prioritize and sortdata based on criticality (e.g., the severity of a medical eventassociated with the data, unexpectedness, suspiciousness). This sortingand prioritization may be used in conjunction with the functions of theother data analytics modules 7034 described above to improve thecloud-based analytics and operations described herein. For example, thedata sorting and prioritization module 7032 can assign a priority to thedata analysis performed by the data collection and aggregation module7022 and patient outcome analysis modules 7028. Different prioritizationlevels can result in particular responses from the cloud 7004(corresponding to a level of urgency) such as escalation for anexpedited response, special processing, exclusion from the aggregatedmedical data databases 7011, or other suitable responses. Moreover, ifnecessary, the cloud 7004 can transmit a request (e.g., a push message)through the hub application servers for additional data fromcorresponding surgical instruments 7012. The push message can result ina notification displayed on the corresponding hubs 7006 for requestingsupporting or additional data. This push message may be required insituations in which the cloud detects a significant irregularity oroutlier and the cloud cannot determine the cause of the irregularity.The central servers 7013 may be programmed to trigger this push messagein certain significant circumstances, such as when data is determined tobe different from an expected value beyond a predetermined threshold orwhen it appears security has been comprised, for example.

Additional example details for the various functions described areprovided in the ensuing descriptions below. Each of the variousdescriptions may utilize the cloud architecture as described in FIGS.180 and 181 as one example of hardware and software implementation.

Usage, Resource, and Efficiency Modeling for Medical Facility

Aspects of the present disclosure are presented for a cloud-basedanalytics system, communicatively coupled to a plurality of hubs andsmart medical instruments, and configured to provide customizedrecommendations to localized medical care facilities regarding usage ofmedical supplies and other resources to improve efficiency and optimizeresource allocation. A medical care facility, such as a hospital ormedical clinic, may develop a set of practices for procuring, using, anddisposing of various medical supplies that are often derived fromroutines and traditions maintained over time. The behaviors of a medicalfacility typically are risk-averse, and generally would be hesitant toadopt new and better practices unless and until convincingly shown of abetter practice. Similarly, even if a better usage or efficiency modelhas been developed in a nearby facility, it is difficult for a localfacility to adopt the improved practice because 1) each facility may bemore natively resistant to change from the outside and 2) there are manyunknowns for how or why the improved practice works in the nearbyfacility in relation to what the local facility does instead.Furthermore, even if a medical facility desired to improve itspractices, it may be unable to do so optimally because it lacks enoughknowledge from other similarly situated facilities, either in itsregion, according to a similar size, and/or according to similarpractices or patients, and the like.

To help facilitate the dissemination of improved practices acrossmultiple medical facilities, it would be desirable if a common sourcecould have knowledge of the contexts from multiple medical facilitiesand be able to determine what changes should be made for any particularmedical facility, based on the knowledge of the practices of any or allof the multiple facilities.

In some aspects, a cloud-based system communicatively coupled toknowledge centers in a medical facility, such as one or more medicalhubs, may be configured to aggregate medical resource usage data frommultiple medical facilities. The cloud-based system may then correlatethe medical resource usage data with outcomes from those facilities, andmay be able to derive various patterns within the data. For example, insome aspects, the cloud-based system may find which hospitals generatethe least amount of waste per unit cost, based on an aggregation of allwaste and procurement data obtained from medical facilities in a widegeographic region (e.g., all surgery centers in Japan). The cloud-basedsystem may be configured to identify which medical facility produced theleast amount of waste per unit cost, and then may analyze what practicesdifferentiate that medical facility. If a trend is found, thecloud-based system may disseminate this information to all of thesimilarly situated medical facilities to improve their practices. Thisanalysis may help improve inventory management, throughput efficiency,or overall efficiency of a medical facility. The improved inventorymanagement may help surgical devices and other medical resources beutilized at their peak performance levels for longer periods of time,compared to if resources were badly managed, and therefore medicaldevices may be continuously used while they are older and more worndown.

In general, the cloud-based system may be configured to aggregate datafrom multiple medical facilities, something that no single facilityalone would be able to accomplish on its own. Furthermore, thecloud-based system may be configured to analyze the large collection ofdata, controlling for common variables, such as type of practice, typeof patient, number of patients, geographic similarity, which facilitiesuse similar types of instruments, etc., that no single facility alonewould be able to analyze on its own.

In this way, the cloud-based system of the present disclosure may beable to find more accurate causalities that lead to best practices at aparticular facility, which can then be disseminated to all of the otherfacilities. Furthermore, the cloud-based system may be able to providethe data from all of the disparate sources that no single facility maybe able to do on its own.

Referring to FIG. 182, shown is an example illustration of a tabulationof various resources correlated to particular types of surgicalcategories. There are two bars for each category, with the dashed linebars 7102, 7106, and 7110 representing unused and/or scrap resources,and the solid line bars 7104, 7108, and 7112 showing a totality ofresourced in use for that category. In this example, bars 7104, 7108,and 7112 show a total amount of endocutter cartridges, sponges, saline,fibrin sealants, sutures, and stapler buttresses, for thoracic,colorectal, and bariatric procedures, respectively, compared to thelower amounts 7102, 7106, and 7110 representing an amount of unusedresources for the thoracic, colorectal, and bariatric procedures,respectively.

The cloud system may be configured to identify wasted product that wasgathered and not used or gathered and used in a manner that was notbeneficial to the patient or the surgery. To do this, the cloud systemmay record in memory all records of inventory intake and disposal.During each intake, the inventory may be scanned and entered, and thebar codes of each inventory item may identify what type of product itis, as an example. In some aspects, smart disposal bins may be utilizedto automatically tabulate when a product is being disposed of. These maybe connected to the cloud system ultimately, either through one or moresurgical hubs or through a separate inventory management systemthroughout the entire facility. Each facility may be tracked by itslocation, for example through a set GPS coordinate, inputted address orthe like. This data may be organized in memory using one or moredatabases with various meta data associated with it, such as date andtime of use, location of origin, type of procedure used for ifapplicable, cost per item, expiration date if applicable, and so on.

In addition, the cloud system may be configured to identify misfired ormisused product and tracking of where the product was used, and mayarchive these results. For example, each surgical instrumentcommunicatively coupled to a surgical hub may transmit a record of whenthe instrument was fired, such as to fire a staple or apply ultrasonicenergy. Each record may be transmitted through the instrument andrecorded at the cloud system ultimately. The action by the instrumentmay be tied with an outcome, either at that instant or with an overalloutcome stating whether the procedure was successful or not. The actionmay be associated with a precise timestamp that places the action at anexact point during a surgery, where all of the actions of the surgeryare also automatically recorded to the cloud, including start and endtimes of the surgery. This enables all of the human medical care workersto focus on their respective duties during surgery, rather than worryabout an exact instance an action of a medical instrument occurred. Therecordings of the medical instruments can be used to identify whatproducts may be wasted during surgery, and the cloud system may beconfigured to also identify usage trends in this way.

In some aspects, the cloud system may be configured to perform trendinganalysis of the product tied to the overall length or amount of theproduct to identify short fires, or discarded product. For example, thecloud system may place the use of a product within a known period ofwhen a surgical procedure is occurring, with a time stamp. The cloudsystem may then record an amount of resources utilized during thatprocedure, and may compare the materials used in that procedure withsimilarly situated procedures performed elsewhere. Out of this, severalconclusions may be reached by the cloud system. For example, the cloudsystem may provide recommendations of a mix that provides smallerportions or an alternative usage that results in less wasted product. Asanother example, the cloud system may provide a suggestion or specifiedprotocol change of specialized kits that would assemble the product in amanner more aligned to the detected institution usage. As yet anotherexample, the cloud system may provide a suggestion or a change inprotocol for alternative product mixes that would be more aligned to thedetected usage and therefore should result in less wasted product. Asyet another example, the cloud system may provide a recommendation onhow to adjust a medical procedure during surgery based on timings ofactions occurring before or after an event that typically results inwasteful resources, such as misfirings or multiple firings, based onidentifying a correlation or pattern that actions during surgeryoccurring within a certain time interval relative to a prior action tendto result in wasteful actions. These analyses may be derived in partusing algorithms that attempt to optimize the available resources withthe rates of their disposals, taking into account various factors suchas misfirings, native practices of the surgeons or the facility atlarge, and so forth.

Still referring to FIG. 182, based on the tabulation of the used andunused product, the cloud system can also generate several otherconclusions. For example, the cloud system may be configured to generatea correlation of unused product to cost overhead. The cloud system mayalso generate a calculation of expired product and how that impactsrates of change with inventory. It may also generate an indication ofwhere in the supply chain the product is being unused and how it isbeing accounted for. It may also generate ways to reduce costs orinventory space by finding substitutes of some resources over others forthe same procedure. This may be based on comparing similar practices atdifferent medical facilities that use different resources to perform thesame procedures.

In some aspects, the cloud system may be configured to analyze theinventory usage of any and all medical products and conduct procurementmanagement for when to acquire new product. The cloud system mayoptimize the utilization of inventory space to determine how best toutilize what space is available, in light of rates of usage for certainproducts compared to others. It may often be the case that inventory isnot closely monitored in terms of how long a product remains in storage.If certain products are utilized at slower rates, but there is a largeamount of it, it may be determined that the storage space is allocatedpoorly. Therefore, the cloud system may better apportion the storagespace to reflect actual resource usage.

To improve in this area, in some aspects, the cloud system may forexample, identify missing or insufficient product within an operatingroom (OR) for a specified procedure. The cloud system may then providean alert or notification or transmit data to display that deficiency atthe surgical hub in the OR. As another example, when a product is usedin the OR, it may communicate its usage information to the cloud, suchas activate a sensor or activation identification. The product may beregistered with a scan or a power on switch. Analysis of thisinformation for a given hospital coupled with its ordering information,may eventually inform the supply status and can enable orderingrecommendations. This may occur automatically, once the cloud systemregisters that products are being used in the OR, or through othermeans.

In some aspects, device utilization within a procedure is monitored bythe cloud system and compared for a given segment (e.g., individualsurgeon, individual hospital, network of hospitals, region, etc.)against device utilization for similar procedures in other segments.Recommendations are presented to optimize utilization based on unitresource used or expenditure spent to supply such resource. In general,the cloud system may focus on a comparison of product utilizationbetween different institutions that it is connected with.

FIG. 183 provides an example illustration of how the data is analyzed bythe cloud system to provide a comparison between multiple facilities tocompare use of resources. In general, the cloud system 7200 may obtainusage data from all facilities, such as any of the types of datadescribed with respect to FIG. 182, and may associate each datum withvarious other meta data, such as time, procedure, outcome of theprocedure, cost, date of acquisition, and so forth. FIG. 183 shows anexample set of data 7202 being uploaded to the cloud 7200, each circlein the set 7202 representing an outcome and one or more resources andcontextual metadata that may be relevant to leading to the outcome. Inaddition, high performing outcomes 7204 and their associated resourcesand contextual metadata are also uploaded to the cloud 7200, though atthe time of upload, it may not be known which data has very goodoutcomes or simply average (or below average) outcomes. The cloud systemmay identify which use of resources is associated with better resultscompared to an average or expected outcome. This may be based ondetermining which resources last longer, are not wasted as often,ultimately cost less per unit time or unit resource, as some examples.The cloud system may analyze the data to determine best outcomes basedon any and all of these variables, or even one or more combinations ofthem. The trends identified may then be used to find a correlation ormay prompt request of additional data associated with these data points.If a pattern is found, these recommendations may be alerted to a user toexamine as possible ways to improve resource usage and efficiency.

The example graph 7206 provides a visual depiction of an example trendor pattern that the cloud may derive from examining the resource andoutcome data, according to some aspects. In this example, the cloudsystem may have analyzed resource and outcome data of number of staplerfirings and their relation to performance in surgery. The cloud systemmay have gathered the data from multiple medical facilities, andmultiple surgeons within each facility, based on automatically recordedfiring data during each surgery that is generated directly from theoperation of the surgical staplers themselves. The performance outcomesmay be based on post-op examinations and evaluations, and/or immediateoutcomes during surgery, such as whether there is a bleeding event or asuccessful wound closure. Based on all of the data, trends may bedetermined, and here, it may be discovered that there is a small windowof the number of firings that results in the best performance outcomes,at interval “a” as shown. The magnitude of this performance compared tothe most common number of firings is shown as interval “b.” Because thenumber of firings that results in the best outcomes may not be what iscommonly practiced, it may not be readily easily to have discoveredthese outcomes without the aggregation and analytical abilities of thecloud system.

As another example: cartridge type, color, and adjunct usage that aremonitored for sleeve gastrectomy procedures for individual surgeonswithin the same hospital may be obtained. The data may reveal an averageprocedure cost for one surgeon is higher for this surgeon when comparedto others within the same hospital, yet short term patient outcomesremain the same. The hospital is then informed and is encouraged to lookinto differences in device utilization, techniques, etc. in search ofoptimizing costs potentially through the elimination of adjuncts.

In some aspects, the cloud system may also identify specialty cases. Forexample, specific cost information provided within the hospital,including OR time, device utilization, and staff, may be identified.These aspects may be unique to a particular OR, or facility. The cloudsystem may be configured to suggest efficiencies in OR time usage(scheduling), device inventory, etc. across specialties (orthopedics,thoracic, colorectal, bariatric, etc.) for these specialty cases.

In some aspects, the cloud system may also be configured to comparecost-benefit of robotic surgery vs traditional methods, such aslaparoscopic procedures for given procedure type. The cloud system maycompare device costs, OR time, patient discharge times, efficacy of theprocedure done by the robot vs performed by surgeons exclusively, andthe like.

Linking of Local Usage Trends with the Resource Acquisition Behaviors ofthe Larger Data Set (Individualized Change)

According to some aspects of the cloud system, whereas the abovedisclosure focuses on a determination of efficiency (i.e., value) andoptimizing based on that, here, this section centers around onidentifying which local practices may be best disseminated to othersimilarly situated medical facilities.

A medical care facility, such as a hospital or medical clinic, maydevelop a set of practices for how to utilize medical devices for aidingmedical procedures that are often derived from routines and traditionsmaintained over time. The behaviors of a medical facility typically arerisk-averse, and generally would be hesitant to adopt new and betterpractices unless and until convincingly shown of a better practice.Similarly, even if a better practice for utilizing a device or foradjusting a procedure has been developed in a nearby facility, it isdifficult for a local facility to adopt the improved practice because 1)each facility may be more natively resistant to change from the outsideand 2) there are many unknowns for how or why the improved practiceworks in the nearby facility in relation to what the local facility doesinstead. Furthermore, even if a medical facility desired to improve itspractices, it may be unable to do so optimally because it lacks enoughknowledge from other similarly situated facilities, either in itsregion, according to a similar size, and/or according to similarpractices or patients, and the like.

To help facilitate the dissemination of improved practices acrossmultiple medical facilities, it would be desirable if a common sourcecould have knowledge of the contexts from multiple medical facilitiesand be able to determine what changes should be made for any particularmedical facility, based on the knowledge of the practices of any or allof the multiple facilities.

In some aspects, a cloud-based system communicatively coupled toknowledge centers in a medical facility, such as one or more medicalhubs, may be configured to aggregate resource utilization data andpatient outcomes from multiple medical facilities. The cloud-basedsystem may then correlate the resource utilization data with theoutcomes from those facilities, and may be able to derive variouspatterns within the data. For example, in some aspects, the cloud-basedsystem may find which hospitals produce better outcomes for a particulartype of procedure, based on an aggregation of all the patient outcomedata for that particular procedure collected in a wide geographic region(e.g., all surgery centers in Germany). The cloud-based system may beconfigured to identify which medical facility produced a betterprocedural outcome compared to the average across the geographic region,and then may analyze what differences in that procedure occur in thatmedical facility. If a trend is found and one or more differences areidentified, the cloud-based system may disseminate this information toall of the similarly situated medical facilities to improve theirpractices.

In general, the cloud-based system may be configured to aggregate datafrom multiple medical facilities, something that no single facilityalone would be able to accomplish on its own. Furthermore, thecloud-based system may be configured to analyze the large collection ofdata, controlling for common variables, such as type of practice, typeof patient, number of patients, geographic similarity, which facilitiesuse similar types of instruments, etc., that no single facility alonewould be able to analyze on its own.

In this way, the cloud-based system of the present disclosure may beable to find more accurate causalities that give rise to best practicesat a particular facility, which can then be disseminated to all of theother facilities. Furthermore, the cloud-based system may be able toprovide the data from all of the disparate sources that no singlefacility may be able to do on its own.

The cloud system may be configured to generate conclusions about theefficacy of any local facility in a number of ways. For example, thecloud system may determine if a local treatment facility is using aproduct mixture or usage that differs from the larger community andtheir outcomes are superior. The cloud system may then correlate thedifferences and highlight them for use in other facilities, othersurgical hub, or in clinical sales as some examples. In general, thisinformation may be disseminated widely in a way that no single facilitymay have had access or knowledge of, including the facility thatpracticed this improve procedure.

As another example, the cloud system may determine if the local facilityhas equal to or inferior outcomes to the larger community. The cloudsystem may then correlate suggestions and provide that information backto the local facility as recommendations. The system may display datashowing their performance in relation to others, and may also displaysuggestions on what that facility is doing compared to what everybodyelse is doing. Again, the local facility may not even know they have aninefficiency in that respect, nor may everybody else realize they areutilizing their resources more efficiently, and thus nobody would everknow to examine these issues without the cloud system having a biggerpicture of all of the data.

These suggestions can come in various forms. For example, the cloudsystem may provide recommendations at the purchasing level that suggestimprovements in cost for similar outcomes. As another example, the cloudsystem may provide recommendations at the OR level when the procedure isbeing planned and outfitted as the less desirable products are beingpulled suggest other techniques and product mixes that would be in linewith the broader community which is achieving higher outcomes. As yetanother example, the cloud system may display outcomes comparison needsto account for surgeon experience, possibly through a count of similarcases performed by that surgeon from cloud data. In some aspects, thelearning curve of an individual may be reported against an aggregatedlarger dataset, as expectation of improved outcomes, or of surgeonperformance relative to peers in obtaining a steady state outcome level.

FIG. 184 illustrates one example of how the cloud system 7300 maydetermine efficacy trends from an aggregated set of data 7302 acrosswhole regions, according to some aspects. Here, for each circle of theset of data 7302, device utilization, cost, and procedure outcomes for aprocedure is monitored and compared for a given segment (e.g.,individual surgeon, individual hospital, network of hospitals, region,etc.) against device utilization, cost, and procedure outcomes forsimilar procedures in other segments. These data may possess metadatathat associates it to a particular facility. In general, an outcome of aprocedure may be linked to multiple types of data associated with it,such as what resources were used, what procedure was performed, whoperformed the procedure, where the procedure was performed, and so on.The data linked to the outcome may then be presented as a data pair. Thedata may be subdivided in various ways, such as between good andinferior outcomes, filtered by particular facilities, particulardemographics, and so forth. A regional filter 7304 is visually depictedas an example. The data set 7302 contains both good outcomes andinferior outcomes, with the inferior outcomes being darkened forcontrast.

FIG. 184 also shows examples of charts that have these distinctions madeand may be derived from the aggregated data set 7302, using one or moredata pairs. Chart 7306 shows a global analysis in one example, while aregionally segmented analysis is provided in the other chart 7308.Statistical analysis may be performed to determine whether the outcomesare statistically significant. In chart 7306, the cloud system maydetermine that no statistical difference was found between good outcomesand inferior outcomes based on rates of occurrence. In contrast, inchart 7308, the cloud system may determine that there is a statisticallyhigher occurrence of inferior outcomes for a given region, whenfiltering for a particular region. Recommendations are presented toshare outcomes vs. cost vs. device utilization and all combinationstherein to help inform optimization of outcomes against procedure costswith device utilization potentially being a key contributor ofdifferences, according to some aspects.

As another example, a cartridge type and color are monitored forlobectomy procedures for individual surgeons within the same hospital.The data reveals average cost for one surgeon is higher on average forthis surgeon, yet average length of stay is less. The hospital isinformed by the cloud system and is encouraged to look into differencesin device utilization, techniques, etc. in search of improving patientoutcomes.

In some aspects, the cloud system may also be configured to providepredictive modeling of changes to procedures, product mixes, and timingfor a given localized population or for the general population as awhole. The predictive modeling may be used to assess impact on resourceutilization, resource efficiency, and resource performance, as someexamples.

FIG. 185 provides an example illustration of some types of analysis thecloud system may be configured to perform to provide the predictingmodeling, according to some aspects. The cloud system may combine itsknowledge of the required steps and instruments for performing aprocedure, and may compare the different avenues via various metrics,such as resources utilized, time, procedural cost, and the like. In thisexample of chart 7400, a thoracic lobectomy procedure is analyzed usingtwo different types of methods to perform the same procedure. Option Adescribes a disposable ultrasonic instrument as the method forperforming the procedure, while Option B shows a combination ofdifferent methods that in the aggregate perform the same procedure. Thegraphical illustration may help a surgeon or administrator see how theresources are utilized and their cost. Option B is broken down intomultiple sections, including sterilization cost, reusable dissectors andadditional time in the OR for performing the procedure. The cloud systemmay be configured to convert these somewhat abstract notions into aquantitative cost value based on combining its knowledge of time spentin the OR, staff salaries and resource costs per unit time in the OR,and resources utilized for sterilization and reusable dissectors andtheir associated costs. The cloud system may be configured to associatethe various amounts of resources and costs with its knowledge of therequired steps to perform the thoracic lobectomy procedure using theprescribed method in Option B.

As another example, chart 7404 in FIG. 185 shows a comparison betweenusing an ultrasonic long dissector and a monopolar reusable dissector toperform various portions of a procedure. Chart 7404 shows a comparisonin terms of time needed to perform each portion of the procedure foreach instrument. The surgeon may then be able to select which instrumentmay be desired for a particular procedure. The breakout times may beautomatically recorded empirically during live procedures, with thetimes for each portion of the overall procedure broken out due to thecloud system's knowledge of the expected sequence to perform theprocedure. Demarcations between each portion may be set by a surgeonproviding an input to manually denote when each change occurs. In othercases, the cloud system may utilize situational awareness to determinewhen a portion of the procedure has ended based on the way the devicesare used and not used. The cloud system may aggregate a number of theseprocedures, performed across multiple surgeons and multiple facilities,and then compute an average time for each section, as an example.

As another example, chart 7402 in FIG. 185 shows an example graphicalinterface for comparing relative cost when utilizing the ultrasonic longdissector or a monopolar reusable dissector, according to some aspect.The value of each instrument per unit time is displayed for a particularprocedure. The data used to generate these values may be similar tothose obtained for charts 7400 and 7404, as some examples. The graphicaldisplay may allow for a succinct description of the key points ofefficiency that would be most useful to make a determination. Thisanalysis may help a surgeon see how valuable each instrument is for agiven procedure.

In general, to perform the predictive modeling, the cloud system maycombine its knowledge of the exact steps to perform a procedure, whatinstruments may be used to perform each step, and its aggregated datafor how each instrument performs each particular step. A surgeon may nothave the combination of such knowledge in order to provide such anassessment alone. The predictive modeling therefore may be the result ofcontinued monitoring and acquisition of data across multiple facilities,the likes of which would not be possible without the cloud system.

In some aspects, the cloud system may also derive the distilledinformation from multiple sources (e.g., HUB data collection sources,literature, etc.) to identify the optimal procedure technique. Variousother examples for how predictive modeling may be utilized include:

(1) sigmoidectomy: multi-quadrant surgery; which is the best order ofoperations, etc.;(2) RYGB: what is the ideal limb length, etc. based on the circumstancesfor this patient;(3) Lobectomy: how many and which lymph nodes should be removed; and(4) VSG: Bougie size and distance from pylorus.

In some aspects, when a suggestion is made to a surgeon, the surgeon isgiven the option to decline future suggestions like this, or tocontinue. In addition, through interface with the hub, the surgeon mayinquire to the cloud system additional information to inform his or herdecision. For example, the surgeon may want to isolate the times to amore localized set of data, such as the particular facility or a certaindemographic that better caters to the patient undergoing the surgery.The data may change, for example, if the patient is a child or thepatient is a woman.

Device Setup Modifications Based on Surgeon, Regional, Hospital, orPatient Parameters (Preoperativelyl)

Similar to the above section, the cloud-based system may also beconfigured to monitor smart instrument configurations and, moregenerally, configurations that utilize multiple smart instruments, suchas an operating room preparing for surgery. For similar reasons asdescribed above, such as to improve medical efficacy and efficiency, itmay be useful to compare a procedural setup at any particular medicalfacility to aggregate data pertaining to the procedural setups atmultiple other medical facilities.

The cloud-based system of the present disclosure may be configured toaggregate data pertaining to smart medical instrument configurations andoperating room (OR) setups that utilize multiple smart medicalinstruments. The smart medical instruments may include: manual devicesthat are communicatively coupled to a medical data tower and areconfigured to generate sensor data; and robotic instruments that performprocedures in a more automated fashion. The cloud-based system may beconfigured to detect irregularities in an OR setup, either pertaining towhat devices are present in the room and/or what materials are used tocreate a product mix for a medical procedure. The irregularities may bebased on comparing the materials and equipment present in the OR withother setups from other medical facilities for a similar situation. Thecloud system may then generate a change in firmware, software, or othersettings and transmit those changes to the surgical devices like adevice update.

In this way, the cloud-based system of the present disclosure may beable to identify errors and find more accurate causalities that giverise to best practices at a particular facility, which can then bedisseminated to all of the other facilities. Furthermore, thecloud-based system may be able to provide the data from all of thedisparate sources that no single facility may be able to do on its own.This can lead to safe and more efficient operating room procedures andmedical practices in general.

In some aspects, the cloud system may be configured to providerecommendations of instrument configurations, and even generate theappropriate device settings changes, to customize performance to that ofa pre-specified user.

For example, the cloud system may focus on a surgical device user orsurgeon based on a comparison of current usage of a device with thehistoric trends of a larger data set. As some examples, the cloud systemmay provide recommendations of what type of cartridge to use based onwhat the user has previously used for the particular procedure or justwhat the particular surgeon desires in general. The cloud system mayaccess data based on the particular surgeon, the type of procedure, andthe type of instruments used in order to make this determination.

As another example, the cloud system may provide a recommendation basedon an identified anatomy indicated in a display of the cartridge. Asanother example, the cloud system may provide a recommendation byreferring to a baseline surgical device clamping and firing speed, basedon local previous usage data that it has stored in its memory.

As yet another example, the cloud system may conduct a comparison ofcurrent device tissue interaction against a historical average for thesame surgeon, or for the same step in the same procedure for a segmentof surgeons in the database. The cloud system again may have access toall steps used to perform a procedure, and may access a catalog of alldata when performing a particular step in a procedure across allsurgeons who have ever performed that procedure in its network. Therecommendation may also come from an analysis of how the currentsurgical device has been observed to interact with tissue historically.This type of analysis may be useful because it is often not the casethat large amounts of live patient data can be collected for how asurgical device interacts precisely with the tissue. Furthermore, asurgeon typically knows only his or her experience, and does not haveoutside knowledge of what other surgeons experience for the sameprocedure. The cloud, on the other hand, is capable of collecting all ofthis data and providing new insights that any individual surgeon wouldnot know alone.

As another example: In stapling, more than one of the following areknown: cartridge color, stapler type, procedure, procedure step, patientinformation, clamp force over time, prior firing information, endeffector deformations, etc. This information is compared against ahistorical average for a similar dataset. The current situation iscompared against this average, informing the user about the nature ofthe current firing.

FIG. 186 provides a graphical illustration of a type of example analysisthe cloud system may perform to provide these recommendations, accordingto some aspects. In this example, chart 7500 shows data for parenchymastaple firing analysis. In the bar graphs 7502 are various types ofstaples used, where each color of staple reflects a different amount offorce applied to the surgical site. The y axis (on the left) associatedwith the bar graphs 7502 reflects a percent level of usage of that typeof staple color, and each color shows bar graphs for three differentcategories: regional average usage (in Japan in this case), globalaverage usage with best outcomes, and the local facility average usage.Based on this data, the cloud system may be configured to develop arecommendation for what staples to change to for a given situation. Aseries of suggested actions is shown in chart 7506 as a result. Thechart 7500 also shows a set of line graphs 7504 that reflect apercentage of prolonged air leaks (the y axis on the right) for eachcolor used, and for each type of category (regional, global average,facility average). If staples are too thick and do not match the levelof tissue thickness, there could be holes in the staples that lead toundesirable air leaks. Here, the cloud system may provide arecommendation based on all of the data shown as well as data not shown,according to some aspects. The cloud system may simply provide arecommendation in the form of a letter as the label, and the surgeon mayverify whether the data supports such a finding and decide to accept thecloud system's recommendation.

As another example, the cloud system may be configured to provide arecommendation of ultrasonic blade lengths or capacities based on likelyto encounter vascular structures in a procedure. Similar to what isdescribed above in reference to FIG. 186, the cloud system may collectthe relevant data for blade lengths, and their outcomes that have beenobtained from multiple surgical hubs, and illustrate the variousoutcomes for using different blade lengths on a particular procedure. Arecommendation may be provided in a graphical display where the surgeoncan verify the recommendation using the graphical presentation createdby the cloud system.

In some aspects, the cloud system is also configured to providerecommendations to the staff about which devices to pull for an upcomingprocedure. These recommendations may be based on a combination ofsurgeon preference (pick list) against historical device utilizationrates for the same procedures performed by some segment of the largerdatabase, as well as average recommendations or utilizations acrossdifferent facilities that produce the best results. The data may beobtained by pairing good outcomes with the metadata, such as whatdevices were used to achieve those good outcomes. Recommendations can beinfluenced by other factors, including patient information, demographicdata, etc.

Relatedly, in some aspects, the cloud system may also provideidentification of pulled instruments that might not be the preferreddevice for a given procedure. The blacklisting of sorts can more clearlyeliminate any obviously flaw uses of devices to help surgeons make thebest decisions. This data may be obtained from manufacturer input,analysis of poor outcomes, specific input provided to the cloud system,and so on.

In addition, based on interrogating tissue for properties (elasticity,impedance, perfusion rate), a specific device with a given parameter set(clamp preload) could be suggested to be used from current stock ininventory by the cloud system. Some of the metadata associated with theoutcomes of past procedures may include a description of the type oftissue being operated on, and an associated description of the physicalcharacteristics of that tissue. The cloud system may then draw trends orpatterns based on different types of procedures, but having in commonall procedures that deal with similar types of tissue. This kind ofanalysis may be used as a secondary recommendation, when a new orunknown procedure must take place and new suggestions are welcome. Ifthe recommendation is accepted, the cloud system may be configured togenerate the change in parameters and transmit them to theinterconnected medical device, through the surgical hub, to make themedical device readily available for use in the adjusted procedure.

In some aspects, the device setup recommendations can includesuggestions of adjuncts for devices based on the pre-surgery imaging orlocally collected data during the beginning of a procedure. That is,this suggestion of adjuncts may be for use on or with devices based onthe local correlation of use to efficacy of the device. As an example,based on a given procedure, surgeon, and patient information, bleedingin a case must be tightly controlled, and therefore the cloud system mayconclude that a buttress is recommended on all staple firings.

In some aspects, the cloud system may also be configured to provideawareness of any newly-launched products that are available and suitablefor operation as well as instructions for use (IFU). The data may begathered from one or more surgical hubs, or from direct factory inputfor the newly-launched products. The cloud system can download theinformation and make the information displayable to multiple medicalhubs across multiple facilities.

In some aspects, regarding any of the above examples for recommendationsbeing provided by the cloud system, the cloud system may also converselyprovide alerts or other signals when a device or suggested setup is notfollowed or is disregarded. The cloud system may be configured to accessprocedural data from a surgical hub during a surgical procedure, forexample. The surgical hub may collect data for what type of devices arein use during a procedure. The cloud system may monitor the progress ofthe procedure by verifying if an accepted method or device is used inthe correct or prescribed order for the procedure. If there is adeviation, in that a particular device is not expected or a step ismissed, the cloud system may send an alert to the surgical hub that aparticular device is not being used properly, as an example. This wouldoccur in real time, as the timing of the procedure is important for thepatient's safety.

Medical Facility Segmented Individualization of Instrument Function

In some aspects, the cloud-based system may also be configured toprovide recommendations or automatically adjust surgical instrumentsettings to account for specific differences at a medical facility.While there are a number of similarities that can be normalized acrossmultiple facilities, there may also be particular differences thatshould be accounted for. For example, patient demographic differences,patient physiological differences more native to a local population,procedural differences—for example preferences by each individualsurgeon—and region specific instrument availability or other differencesmay inspire certain adjustments to be made at any particular medicalfacility.

The cloud-based system of the present disclosure may be configured toaggregate not only data pertaining to smart medical instrumentconfigurations and operating room (OR) setups that utilize multiplesmart medical instruments, but also data that highlight specificdifferences that may be unique to that region or that particular medicalfacility. The cloud-based system may then factor in adjustments todevice settings or recommendations to changes in procedures based onthese differences. For example, the cloud-based system may first providea baseline recommendation for how a smart instrument should be used,based on best practices discovered in the aggregate data. Then, thecloud-based system may augment the recommendation to account for one ormore unique differences specific to a medical facility. Examples ofthese differences are described above. The cloud-based system may bemade aware of what demographics and patient data gave rise to theoptimal baseline procedure, and then compare the local facilitydemographics and patient data against that. The cloud-based system maydevelop or extrapolate a correlation from that baseline setting in orderto develop an adjustment or offset that accounts for the differences indemographics and patient data.

In this way, the cloud-based system of the present disclosure may beable to make optimal adjustments specific to each medical facility oreven specific to each operating room, or surgeon. The adjustments mayoffer improved performance that take into account the observed bestpractices as well as any unique differences.

In some aspects, the cloud system may be configured to provide changesto instrument variation of usage to improve outcomes. For example, thecloud system may determine a localized undesirable effect that is due toa specific manner of utilizing a surgical device. FIG. 187 provides anillustration of how the cloud system may conduct analysis to identify astatistical correlation to a local issue that is tied to how a device isused in the localized setting. The cloud 7600 may aggregate usage dataof all types of devices and record their outcomes. The data set may befiltered down to only those outcomes that utilized the particular devicein question. The cloud system may then perform statistical analysis todetermine if there is a trend in how the procedures are performed at aparticular facility when utilizing that device. A pattern may emergethat suggests there is a consistent flaw in how the device is used atthat facility, represented as the data points 7602 that demonstrate thestatistical correlation. Additional data may then be examined, to see ifa second pattern may arise in comparison to how others are using thedevice in the aggregate. A suggestion may be provided once a pattern isidentified and addressed to the local outlier 7604. In other cases, thecloud system may provide a facility-specific update to the device tooffset the local practice of how that device is used.

In some aspects, the cloud system may be configured to communicate thedeviation to the specific user and the recommendation of a differingtechnique or usage to improve outcomes from the specific device. Thecloud system may transmit the data for display at the surgical hub toillustrate what changes ought to be made.

As an example: A stapler configured with a means to sense the forcerequired to clamp the device transmits data indicating that the clampforce is still rapidly changing (viscoelastic creep) when the surgeoninitiates firing of the staple, and it is observed that the staple linebleeds more often than expected. The cloud system and/or device is ableto communicate a need to wait longer (e.g., 15 seconds) before firingthe device to improve outcomes. This may be based on performing thestatistical analysis described in FIG. 187 using data points fromsimilar procedures aggregated from multiple surgeons and multiplefacilities. In the moment of the surgery, it would be infeasible orimpractical for anybody on the surgery team to come to these conclusionswithout the help of the cloud system aggregating such knowledge andarriving at such conclusions.

In some aspects, the cloud system may also be configured for intentionaldeployment of control algorithms to devices with an in-use criteriameeting specific criteria. For regional differences, the cloud systemmay adjust the control algorithms of various surgical devices. Adifferent amount of force may be applied to a device for patients in adifferent demographic, for example. As another example, surgeons mayhave different uses for a type of surgical device, and controlalgorithms can be adjusted to account for this. The cloud system may beconfigured to send out a wide area update to a device, and may targetthe regional and specific instrument IDs which allow for targetedupdates to their control programs.

In some aspects, the cloud system may provide for coding of the serialnumbers of sales units and/or individual devices, which enables updatedcontrol programs to be pushed to a specific device or specific groups ofdevices based on meeting a specific criteria or threshold.

In addition, according to some aspects, the cloud system may beconfigured to perform analysis of peri-operative data against outcomesdata seeking correlations that identify exceptional results (positiveand negative). The analysis may be performed at multiple levels (e.g.,individual, hospital, and geographic (e.g., city, county, state,country, etc.) filters). Furthermore, regional corroboration of improvedoutcomes may be target for only a limited geographic area, as it isknown that the changes occur only within a limited area. The ability totune devices to regional preferences, techniques, and surgicalpreferences may allow for nuanced improvements for regionally specificareas.

In addition to directly changing instrument settings, the cloud systemmay also be configured to provide recommendations on differentinstruments or equivalent device suggestions due to regionalavailability. That is, an equivalent suggestion to a device to perform aparticular function may be recommended by the cloud system, in the eventa device is lacking and a particular region has an excess or generalavailability of the different device that may be used to serve anequivalent purpose.

For example, the cloud system may determine that PPH hemorrhoid staplingdevices or curved cutter 30 devices are only available in Italy due to aunique procedure configuration or teaching hospital procedure design. Asanother example, the cloud system may determine that there is anAsia-specific TX and open vascular stapler use due to cost sensitivity,lack of laparoscopic adoption, and teaching hospital preferredtechniques and patient thoracic cavity size. As another example, thecloud system may provide awareness messages to OR staff of sub-standardknock-off products available in a certain region. This data may bederived from an ingestion of information from multiple sources, such asinputs provided by experts and doctors, and employing machine learningand natural language processing to interpret trends and news related toa local area. FIG. 188 provides a graphical illustration of an exampleof how some devices may satisfy an equivalent use compared to anintended device. Here, a circular stapling device 7702 is compared to acompression ring 7704 for use in a PPH stapler 7700 for hemorrhoidopexyprocedures. The type of analysis performed to reach the recommendationsby the cloud system may be similar to those described in FIG. 187. Thecloud system may provide a display of this suggestion, as well as ananalysis of its efficiency and resource utilization, in example display7706 that may be shown at a display in a surgical hub. In this case, theinstrument cost is compared, as well as time and efficacy for each typeof instrument. The cloud system may derive these recommendations byobtaining usage examples from different facilities, observing how otherfacilities and doctors treat the same procedure.

In some aspects, the cloud system may also be configured to provide asurgical hub decision tree and local suggestions of post-operative care,based on data processed during the procedure and Cloud Analyticstrending of results or performance of the devices aggregated from largerpopulation sets.

In some aspects, the cloud system may provide update-able decision treesfor post-operative care suggestions, based on device measuredsituational usage. The post-operative care decisions may initially bederived from traditionally known responses that doctors would normallyrecommend. Once additional data becomes available, say from aggregatingtypes of post-operative care from other facilities, or from analyzingnew types of care from literature or from research on new surgicaldevices, the decision can be updated by the cloud system. The decisiontree may be displayable at a surgical hub and in a graphical form.

In using this decision tree, feedback can be provided for each node tostate how effective the current solutions are. The data may be inputtedbased on whatever feedback patients may provide. A doctor or data adminneed not perform any analysis at the time, but the cloud system canaggregate all of the data and observe what trends may arise. Feedbackcan then be provided to update the decision tree.

In some aspects, the cloud system may incorporate operative data &device performance to propose post-operative monitoring & activities.For example, various patient measures may change what decisions inpost-operative care should be taken. These measurements can include butare not limited to: (a) blood pressure; (b) low hematocrit; (c) PTT(partial thromboplastin time); (d) INR (international normalized ratio);(e) Oxygen saturation; (f) Ventilation changes; and (g) X-Ray data.

As another example, anesthesia protocol can dictate what post-operativedecisions should be taken. This may account for: (a) any fluidsadministered; (b) Anesthesia time; and (3) Medications, as somenon-limiting examples.

As another example, the types of medications may also play a role. Theapplication of Warfarin is one notable example. A patientpost-operatively has abnormal PTT and INR, for example. Because thepatient is on Warfarin, potential treatments could include vitamin K,factor 7, or the delivery of plasma (fpp). Plavix can be anotherexample. A patient post-operatively has abnormal PTT and INR. Becausepatient is on Plavix, potential treatments for Warfarin would beineffective. Deliver platelets instead may be the suggestion in thedecision tree.

As a fourth example, post-operative instructions may be provided thatare dependent on the type of procedure. Some non-limiting examplesinclude colorectal time to solid food (motility); and (b) time tophysical activity & PT. These varying decisions can be reflected in thedecision tree, and all of the types of branching decisions may be storedin the cloud system and updated when additional data is gained from anyconnected facility.

FIG. 189 provides various examples of how some data may be used asvariables in deciding how the post-operative decision tree may branchout. As shown, some factors 7802 may include the parameters used insurgical devices, such as the force to fire (FTF) used in an operation,or the force to close (FTC) used in a surgical device. Graph 7800 showsa visual depiction of how the FTC and FTF curves may interrelate withone another. Other factors include compression rate, wait time, andstaple adaptability. Based on some of these variables, a type ofpost-operative care should be adjusted. In this case, a multi-factoredanalysis is applied, which may be too complex to calculate or modifywithout the aid of the processing power of a system like the cloudsystem. This example suggests that a decision tree 7804 provided by thecloud system can be more than a simple two dimensional decision tree. Toaccount for multiple variables to make a single decision, the decisiontree generated by the cloud may be visually available for perhaps just aportion, and the ultimate conclusion may have to be displayed without afull display of all of the other branches that were not considered. Thechart 7806 may be an example of providing additional information of howto respond within the decision tree.

Adaptive Control Program Updates for Surgical Devices

Modular devices include the modules (as described in connection withFIGS. 3 and 9, for example) that are receivable within a surgical huband the surgical devices or instruments that can be connected to thevarious modules. The modular devices include, for example, intelligentsurgical instruments, medical imaging devices, suction/irrigationdevices, smoke evacuators, energy generators, ventilators, andinsufflators. Various operations of the modular devices described hereincan be controlled by one or more control algorithms. The controlalgorithms can be executed on the modular device itself, on the surgicalhub to which the particular modular device is paired, or on both themodular device and the surgical hub (e.g., via a distributed computingarchitecture). In some exemplifications, the modular devices' controlalgorithms control the devices based on data sensed by the modulardevice itself (i.e., by sensors in, on, or connected to the modulardevice). This data can be related to the patient being operated on(e.g., tissue properties or insufflation pressure) or the modular deviceitself (e.g., the rate at which a knife is being advanced, motorcurrent, or energy levels). For example, a control algorithm for asurgical stapling and cutting instrument can control the rate at whichthe instrument's motor drives its knife through tissue according toresistance encountered by the knife as it advances.

Although an “intelligent” device including control algorithms thatrespond to sensed data can be an improvement over a “dumb” device thatoperates without accounting for sensed data, if the device's controlprogram does not adapt or update over time in response to collecteddata, then the devices may continue to repeat errors or otherwiseperform suboptimally. One solution includes transmitting operationaldata collected by the modular devices in combination with the outcomesof each procedure (or step thereof) to an analytics system. In oneexemplification, the procedural outcomes can be inferred by asituational awareness system of a surgical hub to which the modulardevices are paired, as described in U.S. patent application Ser. No.15/940,654, titled SURGICAL HUB SITUATIONAL AWARENESS, which is hereinincorporated by reference in its entirety. The analytics system cananalyze the data aggregated from a set of modular devices or aparticular type of modular device to determine under what conditions thecontrol programs of the analyzed modular devices are controlling themodular devices suboptimally (i.e., if there are repeated faults orerrors in the control program or if an alternative algorithm performs ina superior manner) or under what conditions medical personnel areutilizing the modular devices suboptimally. The analytics system canthen generate an update to fix or improve the modular devices' controlprograms. Different types of modular devices can be controlled bydifferent control programs; therefore, the control program updates canbe specific to the type of modular device that the analytics systemdetermines is performing suboptimally. The analytics system can thenpush the update to the appropriate modular devices connected to theanalytics system through the surgical hubs.

FIG. 190 illustrates a block diagram of a computer-implemented adaptivesurgical system 9060 that is configured to adaptively generate controlprogram updates for modular devices 9050, in accordance with at leastone aspect of the present disclosure. In one exemplification, thesurgical system includes a surgical hub 9000, multiple modular devices9050 communicably coupled to the surgical hub 9000, and an analyticssystem 9100 communicably coupled to the surgical hub 9000. Although asingle surgical hub 9000 is depicted, it should be noted that thesurgical system 9060 can include any number of surgical hubs 9000, whichcan be connected to form a network of surgical hubs 9000 that arecommunicably coupled to the analytics system 9010. In oneexemplification, the surgical hub 9000 includes a processor 9010 coupledto a memory 9020 for executing instructions stored thereon and a datarelay interface 9030 through which data is transmitted to the analyticssystem 9100. In one exemplification, the surgical hub 9000 furtherincludes a user interface 9090 having an input device 9092 (e.g., acapacitive touchscreen or a keyboard) for receiving inputs from a userand an output device 9094 (e.g., a display screen) for providing outputsto a user. Outputs can include data from a query input by the user,suggestions for products or mixes of products to use in a givenprocedure, and/or instructions for actions to be carried out before,during, or after surgical procedures. The surgical hub 9000 furtherincludes an interface 9040 for communicably coupling the modular devices9050 to the surgical hub 9000. In one aspect, the interface 9040includes a transceiver that is communicably connectable to the modulardevice 9050 via a wireless communication protocol. The modular devices9050 can include, for example, surgical stapling and cuttinginstruments, electrosurgical instruments, ultrasonic instruments,insufflators, respirators, and display screens. In one exemplification,the surgical hub 9000 can further be communicably coupled to one or morepatient monitoring devices 9052, such as EKG monitors or BP monitors. Inanother exemplification, the surgical hub 9000 can further becommunicably coupled to one or more databases 9054 or external computersystems, such as an EMR database of the medical facility at which thesurgical hub 9000 is located.

When the modular devices 9050 are connected to the surgical hub 9000,the surgical hub 9000 can sense or receive perioperative data from themodular devices 9050 and then associate the received perioperative datawith surgical procedural outcome data. The perioperative data indicateshow the modular devices 9050 were controlled during the course of asurgical procedure. The procedural outcome data includes data associatedwith a result from the surgical procedure (or a step thereof), which caninclude whether the surgical procedure (or a step thereof) had apositive or negative outcome. For example, the outcome data couldinclude whether a patient suffered from postoperative complications froma particular procedure or whether there was leakage (e.g., bleeding orair leakage) at a particular staple or incision line. The surgical hub9000 can obtain the surgical procedural outcome data by receiving thedata from an external source (e.g., from an EMR database 9054), bydirectly detecting the outcome (e.g., via one of the connected modulardevices 9050), or inferring the occurrence of the outcomes through asituational awareness system. For example, data regarding postoperativecomplications could be retrieved from an EMR database 9054 and dataregarding staple or incision line leakages could be directly detected orinferred by a situational awareness system. The surgical proceduraloutcome data can be inferred by a situational awareness system from datareceived from a variety of data sources, including the modular devices9050 themselves, the patient monitoring device 9052, and the databases9054 to which the surgical hub 9000 is connected.

The surgical hub 9000 can transmit the associated modular device 9050data and outcome data to the analytics system 9100 for processingthereon. By transmitting both the perioperative data indicating how themodular devices 9050 are controlled and the procedural outcome data, theanalytics system 9100 can correlate the different manners of controllingthe modular devices 9050 with surgical outcomes for the particularprocedure type. In one exemplification, the analytics system 9100includes a network of analytics servers 9070 that are configured toreceive data from the surgical hubs 9000. Each of the analytics servers9070 can include a memory and a processor coupled to the memory that isexecuting instructions stored thereon to analyze the received data. Insome exemplifications, the analytics servers 9070 are connected in adistributed computing architecture and/or utilize a cloud computingarchitecture. Based on this paired data, the analytics system 9100 canthen learn optimal or preferred operating parameters for the varioustypes of modular devices 9050, generate adjustments to the controlprograms of the modular devices 9050 in the field, and then transmit (or“push”) updates to the modular devices' 9050 control programs.

Additional detail regarding the computer-implemented interactivesurgical system 9060, including the surgical hub 9000 and variousmodular devices 9050 connectable thereto, are described in connectionwith FIGS. 9-10.

FIG. 191 illustrates a logic flow diagram of a process 9200 for updatingthe control program of a modular device 9050, in accordance with atleast one aspect of the present disclosure. In the following descriptionof the process 9200, reference should also be made to FIG. 190. Theprocess 9200 can be executed by, for example, one or more processors ofthe analytics servers 9070 of the analytics system 9100. In oneexemplification, the analytics system 9100 can be a cloud computingsystem. For economy, the following description of the process 9200 willbe described as being executed by the analytics system 9100; however, itshould be understood that the analytics system 9100 includesprocessor(s) and/or control circuit(s) that are executing the describesteps of the process 9200.

The analytics system 9100 receives 9202 modular device 9050perioperative data and surgical procedural outcome data from one or moreof the surgical hubs 9000 that are communicably connected to theanalytics system 9100. The perioperative data includes preoperativedata, intraoperative data, and/or postoperative data detected by amodular device 9050 in association with a given surgical procedure. Formodular devices 9050 or particular functions of modular devices 9050that are manually controlled, the perioperative data indicates themanner in which a surgical staff member operated the modular devices9050. For modular devices 9050 or particular functions of modulardevices 9050 that are controlled by the modular devices' controlprograms, the perioperative data indicates the manner in which thecontrol programs operated the modular devices 9050. The manner in whichthe modular devices 9050 function under particular sets of conditions(either due to manual control or control by the modular devices' 9050control programs) can be referred to as the “operational behavior”exhibited by the modular device 9050. The modular device 9050perioperative data includes data regarding the state of the modulardevice 9050 (e.g., the force to fire or force to close for a surgicalstapling and cutting instrument or the power output for anelectrosurgical or ultrasonic instrument), tissue data measured by themodular device 9050 (e.g., impedance, thickness, or stiffness), andother data that can be detected by a modular device 9050. Theperioperative data indicates the manner in which the modular devices9050 were programmed to operate or were manually controlled during thecourse of a surgical procedure because it indicates how the modulardevices 9050 functioned in response to various detected conditions.

The surgical procedural outcome data includes data pertaining to anoverall outcome of a surgical procedure (e.g., whether there was acomplication during the surgical procedure) or data pertaining to anoutcome of a specific step within a surgical procedure (e.g., whether aparticular staple line bled or leaked). The procedural outcome data can,for example, be directly detected by the modular devices 9050 and/orsurgical hub 9000 (e.g., a medical imaging device can visualize ordetect bleeding), determined or inferred by a situational awarenesssystem of the surgical hub 9000 as described in U.S. patent applicationSer. No. 15/940,654, or retrieved from a database 9054 (e.g., an EMRdatabase) by the surgical hub 9000 or the analytics system 9100. Theprocedural outcome data can include whether each outcome represented bythe data was a positive or negative result. Whether each outcome waspositive or negative can be determined by the modular devices 9050themselves and included in the perioperative data transmitted to thesurgical hubs 9000 or determined or inferred by the surgical hubs 9000from the received perioperative data. For example, the proceduraloutcome data for a staple line that bled could include that the bleedingrepresented a negative outcome. Similarly, the procedural outcome datafor a staple line that did not bleed could include that the lack ofbleeding represented a positive outcome. In another exemplification, theanalytics system 9100 can be configured to determine whether aprocedural outcome is a positive or negative outcome based upon thereceived procedural outcome data. In some exemplifications, correlatingthe modular device 9050 data to positive or negative procedural outcomesallows the analytics system 9100 to determine whether a control programupdate should be generated 9208.

Upon the analytics system 9100 receiving 9202 the data, the analyticssystem 9100 analyzes the modular device 9050 and procedural outcome datato determine 9204 whether the modular devices 9050 are being utilizedsuboptimally in connection with the particular procedure or theparticular step of the procedure. A modular device 9050 can becontrolled suboptimally if the particular manner in which the modulardevice 9050 is being controlled is repeatedly causing an error or if analternative manner of controlling the modular device 9050 is superiorunder the same conditions. The analytics system 9100 can thus determinewhether a modular device 9050 is being controlled suboptimally (eithermanually or by its control program) by comparing the rate of positiveand/or negative outcomes produced by the modular device 9050 relative toset thresholds or the performance of other modular devices 9050 of thesame type.

For example, the analytics system 9100 can determine whether a type ofmodular device 9050 is being operated suboptimally if the rate ofnegative procedural outcomes produced by the modular device 9050 under aparticular set of conditions in association with a particularoperational behavior exceeds an average or threshold level. As aspecific example, the analytics system 9100 can analyze 9204 whether acontrol program for a surgical stapling instrument that dictates aparticular force to fire (or ranges of forces to fire) is suboptimal fora particular tissue thickness and tissue type. If the analytics system9100 determines that the instrument generates an abnormally high rate ofleaky staple lines when fired at the particular force (e.g., causing thestaples to be malformed, not fully penetrate the tissue, or tear thetissue) relative to an average or threshold staple line leakage rate,then the analytics system 9100 can determine that the control programfor the surgical stapling instrument is performing suboptimally giventhe tissue conditions.

As another example, the analytics system 9100 can determine whether atype of modular device 9050 is being operated suboptimally if the rateof positive outcomes produced by an alternative manner of control undera particular set of conditions in association with a particularoperational behavior exceeds the rate of positive outcomes generated bythe analyzed manner of control under the same conditions. In otherwords, if one subpopulation of the type of modular device 9050 exhibitsa first operational behavior under a certain set of conditions and asecond subpopulation of the same type of modular device 9050 exhibits asecond operational behavior under the same set of conditions, then theanalytics system 9100 can determine whether to update the controlprograms of the modular devices 9050 according to whether the first orsecond operational behavior is more highly correlated to a positiveprocedural outcome. As a specific example, the analytics system 9100 cananalyze 9204 whether a control program for an RF electrosurgical orultrasonic instrument that dictates a particular energy level issuboptimal for a particular tissue type and environmental conditions. Ifthe analytics system 9100 determines that a first energy level given aset of tissue conditions and environmental conditions (e.g., theinstrument being located in a liquid-filled environment, as in anarthroscopic procedure) produces a lower rate of hemostasis than asecond energy level, then the analytics system 9100 can determine thatthe control program for the electrosurgical or ultrasonic instrumentdictating the first energy level is performing suboptimally for thegiven tissue and environmental conditions.

After analyzing 9204 the data, the analytics system 9100 determines 9206whether to update the control program. If the analytics system 9100determines that the modular device 9050 is not being controlledsuboptimally, then the process 9200 continues along the NO branch andthe analytics system 9100 continues analyzing 9204 received 9202 data,as described above. If the analytics system 9100 determines that themodular device 9050 is being controlling suboptimally, then the process9200 continues along the YES branch and the analytics system 9100generates 9208 a control program update. The generated 9208 controlprogram update includes, for example, a new version of the controlprogram for the particular type of modular device 9050 to overwrite theprior version or a patch that partially overwrites or supplements theprior version.

The type of control program update that is generated 9208 by theanalytics system 9100 depends upon the particular suboptimal behaviorexhibited by the modular device 9050 that is identified by the analyticssystem 9100. For example, if the analytics system 9100 determines that aparticular force to fire a surgical stapling instrument results in anincreased rate of leaking staple lines, then the analytics system 9100can generate 9208 a control program update that adjusts the force tofire from a first value to a second value that corresponds to a higherrate of non-leaking staple lines or a lower rate of leaking staplelines. As another example, if the analytics system 9100 determines thata particular energy level for an electrosurgical or ultrasonicinstrument produces a low rate of hemostasis when the instrument is usedin a liquid-filled environment (e.g., due to the energy dissipatingeffects of the liquid), then the analytics system 9100 can generated9208 a control program update that adjusts the energy level of theinstrument when it is utilized in surgical procedures where theinstrument will be immersed in liquid.

The type of control program update that is generated 9208 by theanalytics system 9100 also depends upon whether the suboptimal behaviorexhibited by the modular device 9050 is caused by manual control orcontrol by the control program of the modular device 9050. If thesuboptimal behavior is caused by manual control, the control programupdate can be configured to provide warnings, recommendations, orfeedback to the users based upon the manner in which they are operatingthe modular devices 9050. Alternatively, the control program update canchange the manually controlled operation of the modular device 9050 toan operation that is controlled by the control program of the modulardevice 9050. The control program update may or may not permit the userto override the control program's control of the particular function. Inone exemplification, if the analytics system 9100 determines 9204 thatsurgeons are manually setting an RF electrosurgical instrument to asuboptimal energy level for a particular tissue type or procedure type,then the analytics system 9100 can generate 9208 a control programupdate that provides an alert (e.g., on the surgical hub 9000 or the RFelectrosurgical instrument itself) recommending that the energy level bechanged. In another exemplification, the generated 9208 control programupdate can automatically set the energy level to a default orrecommended level given the particular detected circumstances, whichcould then be changed as desired by the medical facility staff. In yetanother exemplification, the generated 9208 control program update canautomatically set the energy level to a set level determined by theanalytics system 9100 and not permit the medical facility staff tochange the energy level. If the suboptimal behavior is caused by thecontrol program of the modular device 9050, then the control programupdate can alter how the control program functions under the particularset of circumstances that the control program is performing suboptimallyunder.

Once the control program update has been generated 9208 by the analyticssystem 9100, the analytics system 9100 then transmits 9210 or pushes thecontrol program update to all of the modular devices 9050 of therelevant type that are connected to the analytics system 9100. Themodular devices 9050 can be connected to the analytics system 9100through the surgical hubs 900, for example. In one exemplification, thesurgical hubs 9000 are configured to download the control programupdates for the various types of modular devices 9050 from the analyticssystem 9100 each time an update is generated 9208 thereby. When themodular devices 9050 subsequently connect to or pair with a surgical hub9000, the modular devices 9050 then automatically download any controlprogram updates therefrom. In one exemplification, the analytics system9100 can thereafter continue receiving 9202 and analyzing 9204 data fromthe modular devices 9050, as described above.

In one exemplification, instead of the modular devices 9050 transmittingrecorded data to a surgical hub 9000 to which the modular devices 9050are connected, the modular devices 9050 are configured to record theperioperative data and the procedural outcome data on a memory of themodular device 9050. The data can be stored for indefinitely or untilthe data is downloaded from the modular devices 9050. This allows thedata to be retrieved at a later time. For example, the modular devices9050 could be returned to the manufacturer after they are utilized in asurgical procedure. The manufacturer could then download the data fromthe modular devices 9050 and then analyze the data as described above todetermine whether a control program update should be generated for themodular devices 9050. In one exemplification, the data could be uploadedto an analytics system 9100 for analysis, as described above. Theanalytics system 9100 could then generate update control programsaccording to the recorded data and then either incorporate that updatein future manufactured product or push the update to modular devices9050 currently in the field.

In order to assist in the understanding of the process 9200 illustratedin FIG. 191 and the other concepts discussed above, FIG. 192 illustratesa diagram of an illustrative analytics system 9100 updating a surgicalinstrument control program, in accordance with at least one aspect ofthe present disclosure. In one exemplification, a surgical hub 9000 ornetwork of surgical hubs 9000 is communicably coupled to an analyticssystem 9100, as illustrated above in FIG. 190. The analytics system 9100is configured to filter and analyze modular device 9050 data associatedwith surgical procedural outcome data to determine whether adjustmentsneed to be made to the control programs of the modular devices 9050. Theanalytics system 9100 can then push updates to the modular devices 9050through the surgical hubs 9000, as necessary. In the depictedexemplification, the analytics system 9100 comprises a cloud computingarchitecture. The modular device 9050 perioperative data received by thesurgical 9000 hubs from their paired modular devices 9050 can include,for example, force to fire (i.e., the force required to advance acutting member of a surgical stapling instrument through a tissue),force to close (i.e., the force required to clamp the jaws of a surgicalstapling instrument on a tissue), the power algorithm (i.e., change inpower over time of electrosurgical or ultrasonic instruments in responseto the internal states of the instrument and/or tissue conditions),tissue properties (e.g., impedance, thickness, stiffness, etc.), tissuegap (i.e., the thickness of the tissue), and closure rate (i.e., therate at which the jaws of the instrument clamped shut). It should benoted that the modular device 9050 data that is transmitted to theanalytics system 9100 is not limited to a single type of data and caninclude multiple different data types paired with procedural outcomedata. The procedural outcome data for a surgical procedure (or stepthereof) can include, for example, whether there was bleeding at thesurgical site, whether there was air or fluid leakage at the surgicalsite, and whether the staples of a particular staple line were formedproperly. The procedural outcome data can further include or beassociated with a positive or negative outcome, as determined by thesurgical hub 9000 or the analytics system 9100, for example. The modulardevice 9050 data and the procedural outcome data corresponding to themodular device 9050 perioperative data can be paired together orotherwise associated with each other when they are uploaded to theanalytics system 9100 so that the analytics system 9100 is able torecognize trends in procedural outcomes based on the underlying data ofthe modular devices 9050 that produced each particular outcome. In otherwords, the analytics system 9100 can aggregate the modular device 9050data and the procedural outcome data to search for trends or patterns inthe underlying device modular data 9050 that can indicate adjustmentsthat can be made to the modular devices' 9050 control programs.

In the depicted exemplification, the analytics system 9100 executing theprocess 9200 described in connection with FIG. 190 is receiving 9202modular device 9050 data and procedural outcome data. When transmittedto the analytics system 9100, the procedural outcome data can beassociated or paired with the modular device 9050 data corresponding tothe operation of the modular device 9050 that caused the particularprocedural outcome. The modular device 9050 perioperative data andcorresponding procedural outcome data can be referred to as a data pair.The data is depicted as including a first group 9212 of data associatedwith successful procedural outcomes and a second group 9214 of dataassociated with negative procedural outcomes. For this particularexemplification, a subset of the data 9212, 9214 received 9202 by theanalytics system 9100 is highlighted to further elucidate the conceptsdiscussed herein.

For a first data pair 9212 a, the modular device 9050 data includes theforce to close (FTC) over time, the force to fire (FTF) over time, thetissue type (parenchyma), the tissue conditions (the tissue is from apatient suffering from emphysema and had been subject to radiation),what number firing this was for the instrument (third), an anonymizedtime stamp (to protect patient confidentiality while still allowing theanalytics system to calculate elapsed time between firings and othersuch metrics), and an anonymized patient identifier (002). Theprocedural outcome data includes data indicating that there was nobleeding, which corresponds to a successful outcome (i.e., a successfulfiring of the surgical stapling instrument). For a second data pair 9212b, the modular device 9050 data includes the wait time prior theinstrument being fired (which corresponds to the first firing of theinstrument), the FTC over time, the FTF over time (which indicates thatthere was a force spike near the end of the firing stroke), the tissuetype (1.1 mm vessel), the tissue conditions (the tissue had been subjectto radiation), what number firing this was for the instrument (first),an anonymized time stamp, and an anonymized patient identifier (002).The procedural outcome data includes data indicating that there was aleak, which corresponds to a negative outcome (i.e., a failed firing ofthe surgical stapling instrument). For a third data pair 9212 c, themodular device 9050 data includes the wait time prior the instrumentbeing fired (which corresponds to the first firing of the instrument),the FTC over time, the FTF over time, the tissue type (1.8 mm vessel),the tissue conditions (no notable conditions), what number firing thiswas for the instrument (first), an anonymized time stamp, and ananonymized patient identifier (012). The procedural outcome dataincludes data indicating that there was a leak, which corresponds to anegative outcome (i.e., a failed firing of the surgical staplinginstrument). It should be noted again that this data is intended solelyfor illustrative purposes to assist in the understanding of the conceptsdiscussed herein and should not be interpreted to limit the data that isreceived and/or analyzed by the analytics system 9100 to generatecontrol program updates.

When the analytics system 9100 receives 9202 perioperative data from thecommunicably connected surgical hubs 9000, the analytics system 9100proceeds to aggregate and/or store the data according to the proceduretype (or a step thereof) associated with the data, the type of themodular device 9050 that generated the data, and other such categories.By collating the data accordingly, the analytics system 9100 can analyzethe data set to identify correlations between particular ways ofcontrolling each particular type of modular device 9050 and positive ornegative procedural outcomes. Based upon whether a particular manner ofcontrolling a modular device 9050 correlates to positive or negativeprocedural outcomes, the analytics system 9100 can determine 9204whether the control program for the type of modular device 9050 shouldbe updated.

For this particular exemplification, the analytics system 9100 performsa first analysis 9216 a of the data set by analyzing the peak FTF 9213(i.e., the maximum FTF for each particular firing of a surgical staplinginstrument) relative to the number of firings 9211 for each peak FTFvalue. In this exemplary case, the analytics system 9100 can determinethat there is no particular correlation between the peak FTF 9213 andthe occurrence of positive or negative outcomes for the particular dataset. In other words, there are not distinct distributions for the peakFTF 9213 for positive and negative outcomes. As there is no particularcorrelation between peak FTF 9213 and positive or negative outcomes, theanalytics system 9100 would thus determine that a control program updateto address this variable is not necessary. Further, the analytics system9100 performs a second analysis 9216 b of the data set by analyzing thewait time 9215 prior to the instrument being fired relative to thenumber of firings 9211. For this particular analysis 9216 b, theanalytics system 9100 can determine that there is a distinct negativeoutcome distribution 9217 and a positive outcome distribution 9219. Inthis exemplary case, the negative outcome distribution 9217 has a meanof 4 seconds and the positive outcome distribution has a mean of 11seconds. Thus, the analytics system 9100 can determine that there is acorrelation between the wait time 9215 and the type of outcome for thissurgical procedure step. Namely, the negative outcome distribution 9217indicates that there is a relatively large rate of negative outcomes forwait times of 4 seconds or less. Based on this analysis 9216 bdemonstrating that there is a large divergence between the negativeoutcome distribution 9217 and the positive outcome distribution 9219,the analytics system 9100 can then determine 9204 that a control programupdate should be generated 9208.

Once the analytics system 9100 analyzes the data set and determines 9204that an adjustment to the control program of the particular moduledevice 9050 that is the subject of the data set would improve theperformance of the modular device 9050, the analytics system 9100 thengenerates 9208 a control program update accordingly. In this exemplarycase, the analytics system 9100 can determine based on the analysis 9216b of the data set that a control program update 9218 recommending a waittime of more than 5 seconds would prevent 90% of the distribution of thenegative outcomes with a 95% confidence interval. Alternatively, theanalytics system 9100 can determine based on the analysis 9216 b of thedata set that a control program update 9218 recommending a wait time ofmore than 5 seconds would result in the rate of positive outcomes beinggreater than the rate of negative outcomes. The analytics system 9100could thus determine that the particular type of surgical instrumentshould wait more than 5 seconds before being fired under the particulartissue conditions so that negative outcomes are less common thanpositive outcomes. Based on either or both of these constraints forgenerating 9208 a control program update that the analytics system 9100determines are satisfied by the analysis 9216 b, the analytics system9100 can generate 9208 a control program update 9218 for the surgicalinstrument that causes the surgical instrument, under the givencircumstances, to either impose a 5 second or longer wait time beforethe particular surgical instrument can be fired or causes the surgicalinstrument to display a warning or recommendation to the user thatindicates to the user that the user should wait at least 5 secondsbefore firing the instrument. Various other constraints can be utilizedby the analytics system 9100 in determining whether to generate 9208 acontrol program update, such as whether a control program update wouldreduce the rate of negative outcomes by a certain percentage or whethera control program update maximizes the rate of positive outcomes.

After the control program update 9218 is generated 9208, the analyticssystem 9100 then transmits 9210 the control program update 9218 for theappropriate type of modular devices 9050 to the surgical hubs 9000. Inone exemplification, when a modular device 9050 that corresponds to thecontrol program update 9218 is next connected to a surgical hub 9000that has downloaded the control program update 9218, the modular device9050 then automatically downloads the update 9218. In anotherexemplification, the surgical hub 9000 controls the modular device 9050according to the control program update 9218, rather than the controlprogram update 9218 being transmitted directly to the modular device9050 itself.

In one aspect, the surgical system 9060 is configured to push downverification of software parameters and updates if modular devices 9050are detected to be out of date in the surgical hub 9000 data stream.FIG. 193 illustrates a diagram of an analytics system 9100 pushing anupdate to a modular device 9050 through a surgical hub 9000, inaccordance with at least one aspect of the present disclosure. In oneexemplification, the analytics system 9000 is configured to transmit agenerated control program update for a particular type of modular device9050 to a surgical hub 9000. In one aspect, each time a modular device9050 connects to a surgical hub 9000, the modular device 9050 determineswhether there is an updated version of its control program on orotherwise accessible via the surgical hub 9000. If the surgical hub 9000does have an updated control program (or the updated control program isotherwise available from the analytics system 9100) for the particulartype of modular device 9050, then the modular device 9050 downloads thecontrol program update therefrom.

In one exemplification, any data set being transmitted to the analyticssystems 9100 includes a unique ID for the surgical hub 9000 and thecurrent version of its control program or operating system. In oneexemplification, any data set being sent to the analytics systems 9100includes a unique ID for the modular device 9050 and the current versionof its control program or operating system. The unique ID of thesurgical hub 9000 and/or modular device 9050 being associated with theuploaded data allows the analytics system 9100 to determine whether thedata corresponds to the most recent version of the control program. Theanalytics system 9100 could, for example, elect to discount (or ignore)data generated by a modular device 9050 or surgical hub 9000 beingcontrolled by an out of date control program and/or cause the updatedversion of the control program to be pushed to the modular device 9050or surgical hub 9000.

In one exemplification, the operating versions of all modular devices9050 the surgical hub 9000 has updated control software for could alsobe included in a surgical hub 9000 status data block that is transmittedto the analytics system 9100 on a periodic basis. If the analyticssystem 9100 identifies that the operating versions of the controlprograms of the surgical hub 9100 and/or any of the connectable modulardevices 9050 are out of date, the analytics system 9100 could push themost recent revision of the relevant control program to the surgical hub9000.

In one exemplification, the surgical hub 9000 and/or modular devices9050 can be configured to automatically download any software updates.In another exemplification, the surgical hub 9000 and/or modular devices9050 can be configured to provide a prompt for the user to ask at thenext setup step (e.g., between surgical procedures) if the user wants toupdate the out of date control program(s). In another exemplification,the surgical hub 9000 could be programmable by the user to never allowupdates or only allow updates of the modular devices 9050 and not thesurgical hub 9000 itself.

Adaptive Control Program Updates for Surgical Hubs

As with the modular devices 9050 described above, the surgical hubs 9000can likewise include control programs that control the variousoperations of the surgical hub 9000 during the course of a surgicalprocedure. If the surgical hubs' 9000 control programs do not adapt overtime in response to collected data, then the surgical hubs 9000 maycontinue to repeat errors, not provide warnings or recommendations tothe surgical staff based on learned information, and not adjust to thesurgical staff's preferences. One solution includes transmittingoperational data from the surgical hubs 9000 that indicates how thesurgical hubs 9000 are being utilized or controlled during the course ofa surgical procedure to an analytics system 9100. The analytics system9100 can then analyze the data aggregated from the network of surgicalhubs 9000 connected to the analytics system 9100 to determine if aparticular manner of operating the surgical hubs 9000 corresponds toimproved patient outcomes or is otherwise preferred across thepopulation of the surgical hubs 9000. In one exemplification, if aparticular manner in which the surgical hubs 9000 are operated satisfiesa defined condition or set of conditions, then the analytics system 9100can determine that this particular manner should be implemented acrossthe network of surgical hubs 9000. The analytics system 9100 cangenerate an update to the surgical hubs' 9000 control program to fix orimprove the control program and then push the update to the surgicalhubs 9000 so that the improvement is shared across every surgical hub9000 that is connected to the analytics system 9100. For example, if athreshold number of the surgical hubs 9000 are controlled in aparticular manner and/or if a particular manner of controlling thesurgical hubs 9000 correlates to an improvement in the surgicalprocedure outcomes that exceeds a threshold level, then the analyticssystem 9100 can generate a control program update that controls thesurgical hubs 9000 in a manner corresponding to the preferred orimproved manner of control. The control program update can then bepushed to the surgical hubs 9000.

In one exemplification, an analytics system 9100 is configured togenerate and push control program updates to surgical hubs 9000 in thefield based on perioperative data relating to the manner in which thesurgical hubs 9000 are controlled or utilized. In other words, thesurgical hubs 9000 can be updated with improved decision-makingabilities according to data generated from the hub network. In oneaspect, external and perioperative data is collected by an analyticssystem. The data is then analyzed to generate a control update toimprove the performance of the surgical hubs 9000. The analytics system9100 can analyze the data aggregated from the surgical hubs 9000 todetermine the preferred manner for the surgical hubs 9000 to operate,under what conditions the surgical hubs' 9000 control programs arecontrolling the surgical hubs 9000 suboptimally (i.e., if there arerepeated faults or errors in the control program or if an alternativealgorithm performs in a superior manner), or under what conditionsmedical personnel are utilizing the surgical hubs 9000 suboptimally. Theanalytics system 9100 can then push the update to the surgical hubs 9000connected thereto.

FIG. 194 illustrates a diagram of a computer-implemented adaptivesurgical system 9060 that is configured to adaptively generate controlprogram updates for surgical hubs 9000, in accordance with at least oneaspect of the present disclosure. The surgical system 9060 includesseveral surgical hubs 9000 that are communicably coupled to theanalytics system 9100. Subpopulations of surgical hubs 9000 (each ofwhich can include individual surgical hubs 9000 or groups of surgicalhubs 9000) within the overall population connected to the analyticssystem 9100 can exhibit different operational behaviors during thecourse of a surgical procedure. The differences in operational behaviorbetween groups of surgical hubs 9000 within the population can resultfrom the surgical hubs 9000 running different versions of their controlprogram, by the surgical hubs' 9000 control programs being customized orprogrammed differently by local surgical staff, or by the local surgicalstaff manually controlling the surgical hubs 9000 differently. In thedepicted example, the population of surgical hubs 9000 includes a firstsubpopulation 9312 that is exhibiting a first operational behavior and asecond subpopulation 9314 that is exhibiting a second operationalbehavior for a particular task. Although the surgical hubs 9000 aredivided into a pair of subpopulations 9312, 9314 in this particularexample, there is no practical limit to the number of differentbehaviors exhibited within the population of surgical hubs 9000. Thetasks that the surgical hubs 9000 can be executing include, for example,controlling a surgical instrument or analyzing a dataset in a particularmanner.

The surgical hubs 9000 can be configured to transmit perioperative datapertaining to the operational behavior of the surgical hubs 9000 to theanalytics system 9100. The perioperative data can include preoperativedata, intraoperative data, and postoperative data. The preoperative datacan include, for example, patient-specific information, such asdemographics, health history, preexisting conditions, preoperativeworkup, medication history (i.e., medications currently and previouslytaken), genetic data (e.g., SNPs or gene expression data), EMR data,advanced imaging data (e.g., MRI, CT, or PET), metabolomics, andmicrobiome. Various additional types of patient-specific informationthat can be utilized by the analytics system 9100 are described by U.S.Pat. No. 9,250,172, U.S. patent application Ser. No. 13/631,095, U.S.patent application Ser. No. 13/828,809, and U.S. Pat. No. 8,476,227,each of which is incorporated by reference herein to the extent thatthey describe patient-specific information. The preoperative data canalso include, for example, operating theater-specific information, suchas geographic information, hospital location, operating theaterlocation, operative staff performing the surgical procedure, theresponsible surgeon, the number and type of modular devices 9050 and/orother surgical equipment that could potentially be used in theparticular surgical procedure, the number and type of modular devices9050 and/or other surgical equipment that are anticipated to be used inthe particular surgical procedure, patient identification information,and the type of procedure being performed.

The intraoperative data can include, for example, modular device 9050utilization (e.g., the number of firings by a surgical staplinginstrument, the number of firings by an RF electrosurgical instrument oran ultrasonic instrument, or the number and types of stapler cartridgesutilized), operating parameter data of the modular devices 9050 (e.g.,the FTF curve for a surgical stapling instrument, a FTC curve for asurgical stapling instrument, the energy output of a generator, theinternal pressure or pressure differential of a smoke evacuator),unexpected modular device 9050 utilization (i.e., the detection of theutilization of a modular device that is nonstandard for the proceduretype), adjunctive therapies administered to the patient, and utilizationof equipment other than the modular devices 9050 (e.g., sealants toaddress leaks). The intraoperative data can also include, for example,detectable misuse of a modular device 9050 and detectable off-label useof a modular device 9050.

The postoperative data can include, for example, a flag if the patientdoes not leave the operating theater and/or is sent for nonstandardpostoperative care (e.g., a patient undergoing a routine bariatricprocedure is sent to the ICU after the procedure), a postoperativepatient evaluation relating to the surgical procedure (e.g., datarelating to a spirometric performance after a thoracic surgery or datarelating to a staple line leakage after bowel or bariatric procedures),data related to postoperative complications (e.g., transfusions or airleaks), or the patient's length of stay in the medical facility afterthe procedure. Because hospitals are increasingly being graded onreadmission rates, complication rates, average length of stay, and othersuch surgical quality metrics, the postoperative data sources can bemonitored by the analytics system 9100 either alone or in combinationwith surgical procedural outcome data (discussed below) to assess andinstitute updates to the controls programs of the surgical hubs 9000and/or modular devices 9050.

In some exemplifications, the intraoperative and/or postoperative datacan further include data pertaining to the outcome of each surgicalprocedure or a step of the surgical procedure. The surgical proceduraloutcome data can include whether a particular procedure or a particularstep of a procedure had a positive or negative outcome. In someexemplifications, the surgical procedural outcome data can includeprocedure step and/or time stamped images of modular device 9050performance, a flag indicating whether a modular device 9050 functionedproperly, notes from the medical facility staff, or a flag for poor,suboptimal, or unacceptable modular device 9050 performance. Thesurgical procedural outcome data can, for example, be directly detectedby the modular devices 9050 and/or surgical hub 9000 (e.g., a medicalimaging device can visualize or detect bleeding), determined or inferredby a situational awareness system of the surgical hub 9000 as describedin U.S. patent application Ser. No. 15/940,654, or retrieved from adatabase 9054 (e.g., an EMR database) by the surgical hub 9000 or theanalytics system 9100. In some exemplifications, perioperative dataincluding a flag indicating that a modular device 9050 failed orotherwise performed poorly during the course of a surgical procedure canbe prioritized for communication to and/or analysis by the analyticssystem 9100.

In one exemplification, the perioperative data can be assembled on aprocedure-by-procedure basis and uploaded by the surgical hubs 9000 tothe analytics system 9100 for analysis thereby. The perioperative dataindicates the manner in which the surgical hubs 9000 were programmed tooperate or were manually controlled in association with a surgicalprocedure (i.e., the operational behavior of the surgical hubs 9000)because it indicates what actions the surgical hub 9000 took in responseto various detected conditions, how the surgical hubs 9000 controlledthe modular devices 9050, and what inferences the situationally awaresurgical hubs 9000 derived from the received data. The analytics system9100 can be configured to analyze the various types and combinations ofpreoperative, intraoperative, and post-operative data to determinewhether a control program update should be generated and then push theupdate to the overall population or one or more subpopulations ofsurgical hubs 9000, as necessary.

FIG. 195 illustrates a logic flow diagram of a process 9300 for updatingthe control program of a surgical hub 9000, in accordance with at leastone aspect of the present disclosure. During the following descriptionof the process 9300, reference should also be made to FIGS. 190 and 194.The process 9200 can be executed by, for example, one or more processorsof the analytics servers 9070 of the analytics system 9100. In oneexemplification, the analytics system 9100 can be a cloud computingsystem. For economy, the following description of the process 9300 willbe described as being executed by the analytics system 9100; however, itshould be understood that the analytics system 9100 includesprocessor(s) and/or control circuit(s) that are executing the describesteps of the process 9300.

The analytics system 9100 executing the process 9300 receives 9302perioperative data from the surgical hubs 9000 that are communicablyconnected to the analytics system 9100. The perioperative data indicatesthe manner in which the surgical hubs 9000 are programmed to operate bytheir control programs or are controlled by the surgical staff during asurgical procedure. In some aspects, the perioperative data can includeor being transmitted to the analytics system 9100 in association withsurgical procedural outcome data. The surgical procedural outcome datacan include data pertaining to an overall outcome of a surgicalprocedure (e.g., whether there was a complication during the surgicalprocedure) or data pertaining to a specific step within a surgicalprocedure (e.g., whether a particular staple line bled or leaked).

After an analytics system 9100 executing the process 9300 has received9302 the perioperative data, the analytics system 9100 then analyzes9304 the data to determine whether an update condition has beensatisfied. In one exemplification, the update condition includes whethera threshold number or percentage of surgical hubs 9000 within thepopulation exhibit a particular operational behavior. For example, theanalytics system 9100 can determine that a control program update shouldbe generated to automatically active an energy generator at a particularstep in a type of surgical procedure when a majority of the surgicalhubs 9000 are utilized to active the energy generator at that proceduralstep. In another exemplification, the update condition includes whetherthe rate of positive procedural outcomes (or lack of negative proceduraloutcomes) correlated to a particular operational behavior exceeds athreshold value (e.g., an average rate of positive procedural outcomesfor a procedure step). For example, the analytics system 9100 candetermine that a control program update should be generated to recommendthat the energy generator be set at a particular energy level when theassociated rate of hemostasis (i.e., lack of bleeding) at that energylevel for the particular tissue type exceeds a threshold rate. Inanother exemplification, the update condition includes whether the rateof positive procedural outcomes (or lack of negative proceduraloutcomes) for a particular operational behavior is higher than the rateof positive procedural outcomes (or a lack of negative proceduraloutcomes) for related operational behaviors. In other words, if onesubpopulation of surgical hubs 9000 exhibits a first operationalbehavior under a certain set of conditions and a second subpopulation ofsurgical hubs 9000 exhibits a second operational behavior under the sameset of conditions, then the analytics system 9100 can determine whetherto update the control programs of the surgical hubs 9000 according towhether the first or second operational behavior is more highlycorrelated to a positive procedural outcome. In another exemplification,the analytics system 9100 analyzes 9304 the data to determine whethermultiple update conditions have been satisfied.

If an update condition has not been satisfied, the process 9300continues along the NO branch and the analytics system 9100 continuesreceiving 9302 and analyzing 9304 perioperative data from the surgicalhubs 9000 to monitor for the occurrence of an update condition. If anupdate condition has been satisfied, the process 9300 continues alongthe YES branch and the analytics system 9100 proceeds to generate 9308 acontrol program update. The nature of the generated 9308 control programupdate corresponds to the particular operational behavior of thesurgical hub 9000 that is identified by the analytics system 9100 astriggering the update condition. In other words, the control programupdate adds, removes, or otherwise alters functions performed by thesurgical hub 9000 so that the surgical hub 9000 operates differentlyunder the conditions that gave rise to the identified operationalbehavior. Furthermore, the type of control program update also dependsupon whether the identified operational behavior results from manualcontrol or control by the control program of the surgical hub 9000. Ifthe identified operational behavior results from manual control, thecontrol program update can be configured to provide warnings,recommendations, or feedback to the users based upon the manner in whichthey are operating the surgical hub 9000. For example, if the analyticssystem 9100 determines that taking a particular action or utilizing aparticular instrument for a step in a surgical procedure improvesoutcomes, then the analytics system 9100 can generate 9308 a controlprogram update that provides a prompt or warning to the surgical staffwhen the surgical hub 9000 determines that the designated step of thesurgical procedure is occurring or will subsequently occur.Alternatively, the control program update can change one or morefunctions of the surgical hub 9000 from being manually controllable tobeing controlled by the control program of the surgical hub 9000. Forexample, if the analytics system 9100 determines that a display of thevisualization system 108 (FIG. 2) is set to a particular view by thesurgical staff in a predominant number of surgical procedures at aparticular step, the analytics system 9100 can generate a controlprogram update that causes the surgical hub 9000 to automatically changethe display to that view under those conditions. If the identifiedoperational behavior results from the control program of the surgicalhub 9000, then the control program update can alter how the controlprogram functions under the set of circumstances that cause theidentified operational behavior. For example, if the analytics system9100 determines that a particular energy level for an RF electrosurgicalor ultrasonic instrument correlates to poor or negative outcomes under acertain set of conditions, then the analytics system 9100 can generate9308 a control program update that causes the surgical hub 9000 toadjust the energy level of the connected instrument to a different valuewhen the set of conditions is detected (e.g., when the surgical hub 9000determines that an arthroscopic procedure is being performed).

The analytics system 9100 then transmits 9310 the control program updateto the overall population of surgical hubs 9000 or the subpopulation(s)of surgical hubs 9000 that are performing the operational behavior thatis identified by the analytics system 9100 as triggering the updatecondition. In one exemplification, the surgical hubs 9000 are configuredto download the control program updates from the analytics system 9100each time an update is generated 9308 thereby. In one exemplification,the analytics system 9100 can thereafter continue the process 9300 ofanalyzing 9304 the data received 9302 from the surgical hubs 9000, asdescribed above.

FIG. 196 illustrates a representative implementation of the process 9300depicted in FIG. 195. FIG. 196 illustrates a logic flow diagram of aprocess 9400 for updating the data analysis algorithm of a controlprogram of a surgical hub 9000, in accordance with at least one aspectof the present disclosure. As with the process 9300 depicted in FIG.195, the process 9400 illustrated in FIG. 196 can, in oneexemplification, be executed by the analytics system 9100. In thefollowing description of the process 9400, reference should also be madeto FIG. 194. In one exemplification of the adaptive surgical system 9060depicted in FIG. 194, the first surgical hub subpopulation 9312 isutilizing a first data analysis algorithm and the second surgical hubsubpopulation 9314 is utilizing a second data analysis algorithm. Forexample, the first surgical hub subpopulation 9312 can be utilizing anormal continuous probability distribution to analyze a particulardataset, whereas the second surgical hub subpopulation 9314 can beutilizing a bimodal distribution for analyzing the particular dataset.In this exemplification, the analytics system 9100 receives 9402, 9404the perioperative data from the first and second surgical hubsubpopulations 9312, 9314 corresponding to the respective data analysisalgorithms. The analytics system 9100 then analyzes 9406 theperioperative datasets to determine whether one of the perioperativedatasets satisfies one or more update conditions. The update conditionscan include, for example, a particular analysis method being utilized bya threshold percentage (e.g., 75%) of the surgical hubs 9000 in theoverall population and a particular analysis method being correlated topositive surgical procedural outcomes in a threshold percentage (e.g.,50%) of cases.

In this exemplification, the analytics system 9100 determines 9408whether one of the data analysis algorithms utilized by the first andsecond surgical hub subpopulations 9312, 9314 satisfies both of theupdate conditions. If the update conditions are not satisfied, then theprocess 9400 proceeds along the NO branch and the analytics system 9100continues receiving 9402, 9404 and analyzing 9406 perioperative datafrom the first and second surgical hub subpopulations 9312, 9314. If theupdate conditions are satisfied, the process 9400 proceeds along the YESbranch and the analytics system 9100 generates 9412 a control programupdate according to which of the data analysis algorithms the analysis9406 determined satisfied the update conditions. In thisexemplification, the control program update would include causing thesurgical hub 9000 to utilize the data analysis algorithm that satisfiedthe update conditions when performing the corresponding analysis type.The analytics system 9100 then transmits 9414 the generated 9412 controlprogram update to the population of surgical hubs 9000. In oneexemplification, the control program update is transmitted 9414 to theentire population of surgical hubs 9000. In another exemplification, thecontrol program update is transmitted 9414 to the subpopulation ofsurgical hubs 9000 that did not utilize the data analysis algorithm thatsatisfied the update conditions. In other words, if the analytics system9100 analyzes 9406 the perioperative data and determines 9408 that thesecond (bimodal) data analysis method satisfies the update conditions,then the generated 9412 control program update is transmitted 9414 tothe first subpopulation of surgical hubs 9000 in this exemplification.Furthermore, the control program update can either force the updatedsurgical hubs 9000 to utilize the second (bimodal) data analysisalgorithm when analyzing the particular dataset or cause the updatedsurgical hubs 9000 to provide a warning or recommend to the user thatthe second (bimodal) data analysis algorithm be used under the givenconditions (allowing the user to choose whether to follow therecommendation).

This technique improves the performance of the surgical hubs 9000 byupdating their control programs generated from data aggregated acrossthe entire network of surgical hubs 9000. In effect, each surgical hub9000 can be adjusted according to shared or learned knowledge across thesurgical hub 9000 network. This technique also allows the analyticssystem 9100 to determine when unexpected devices (e.g., modular devices9050) are utilized during the course of a surgical procedure byproviding the analytics system 9100 with knowledge of the devices beingutilized in each type of surgical procedure across the entire surgicalhub 9000 network.

Security and Authentication Trends and Reactive Measures

In a cloud-based medical system communicatively coupled to multiplecommunication and data gathering centers located in differentgeographical areas, security risks are ever present. The cloud-basedmedical system may aggregate data from the multiple communication anddata gathering centers, where the data collected by any data gatheringcenter may originate from one or more medical devices communicativelycoupled to the data gathering center. It may be possible to connect anunauthorized medical device to the data gathering center, such as apirated device, a knock-off or counterfeit device, or a stolen device.These devices may contain viruses, may possess faulty calibration, lackthe latest updated settings, or otherwise fail to pass safetyinspections that can be harmful to a patient if used during surgery.Furthermore, the multiple data gathering centers may contain multiplepoints of entry, such as multiple USB or other input ports, oropportunities to enter user passwords, that if improperly accessed couldrepresent security breaches that can reach the cloud-based medicalsystem, other data gathering centers, and connected medical devices. Therisk of devices being tampered with, or data being stolen ormanipulated, can lead to severe consequences, particularly because theentire system is purposed for improving medical care.

A security system that reaches all facets of the cloud-based medicalsystem may not be effective unless there is a centralized component thatis configured to be made aware of all communication and data gatheringcenters, and all devices connected therein. If the security systems weremerely localized to each data gathering center or at each point ofentry, information from one point of entry may not be properlydisseminated to other security points. Thus, if a breach occurs at onepoint, or if improper devices are used at one point, that informationmay not be properly disseminated to the other centers or devices.Therefore, a centralized security system, or at least a systemconfigured to communicate with all medical hubs that control accesspoints, would be preferable to be made aware of all of the differentissues that may occur and to communicate those issues to other ports asneeded.

In some aspects, the cloud-based medical system includes a security andauthentication system that is configured to monitor all communicationand data gathering centers, such as a medical hub or tower located in anoperating room, as well as any smart medical instruments communicativelycoupled to those centers. The cloud-based security and authenticationsystem, as part of the cloud-based medical system, may be configured todetect unauthorized or irregular access to any hub system or otherprotected data sets contained within the cloud. Because of thecentralized nature of the cloud-based security system—in the sense thatthe cloud system is configured to communicate with every hub in thesystem—if there is any identified irregularity found at one hub, thesecurity system is operable to improve security at all other hubs bycommunicating this information to the other hubs. For example, ifsurgical instruments with unauthorized serial numbers are used at a hubin one hospital, the cloud-based security system may learn of this atthe local hub located in that hospital, and then communicate thatinformation to all other hubs in the same hospital, as well as allhospitals in the surrounding region.

In some aspects, the cloud-based medical system may be configured tomonitor surgical devices and approve or deny access for each surgicaldevice for use with a surgical hub. Each surgical device may beregistered with a hub, by performing an authentication protocol exchangewith the hub. The cloud-based medical system may possess knowledge ofall surgical devices and a status indicating whether the surgical deviceis acceptable, such as whether the device has been pirated, lacks aproper serial number, was faulty, possesses a virus, as so on. Thecloud-based medical system may then be configured to prevent interactionwith the surgical device, even if the surgical device is connected tothe hub.

In this way, the cloud-based security system can provide the mostcomprehensive security for any particular hub or medical facility due toits ability to see problems located elsewhere.

FIG. 197 provides an illustration of example functionality by a cloudmedical analytics system 10000 for providing improved security andauthentication to multiple medical facilities that are interconnected,according to some aspects. Starting at block A reference 10002,suspicious activity may be registered from one facility or region as astarting point. The suspicious activity may come in various forms. Forexample, a surgical device may be recorded at a hub as having aduplicate serial number, or a number that is not known to be within anacceptable range, or that the serial number may already be registered ata different location. In some aspects, surgical devices may possessadditional authentication mechanisms, such as a type of electronic ordigital handshake exchange between the surgical device and the surgicalhub when they are connected. Each device may be programmed with adigital signature and/or knowledge of how to perform an authenticationprocess. The firmware of the surgical device may need to be properlyprogrammed to know how to perform during this exchange. Theauthentication handshake may periodically change, and may be specifiedby the cloud on a periodic basis. Any of these may fail duringinterconnection of the device with a medical hub, triggering an alertwith the medical hub and the cloud system 10000.

In some aspects, the cloud system 10000 may review the informationsupplied by the medical device that triggered the suspicious activity,and if the information is unequivocally fraudulent or faulty, an alertand a rejection of the device can occur, such that the medical devicewill be prevented from operating with the medical hub and/or othermedical hubs in the same facility. While the cloud system 10000 may beconfigured to prevent singularities, the cloud system 10000 may also becapable of utilizing its vast array of knowledge to develop additionalsecurity measures that a single hub as an entry port would be unable toperform on its own. An example is described further below.

At block B reference 10004, the activity at the local medical hub may betransmitted to the cloud for authentication by at least comparing thesurgical device to all known devices within the cloud network. In thisscenario, the surgical device may register as being suspicious or havingsome suspicious activity or property. The cloud may be configured tothen undergo a feedback loop of exchange with the local hub or facilityfrom which the suspicious device originated. The cloud may determine torequest additional data from that facility. In addition, the medicalfacility, via one or more surgical hubs, may request authentication orinterrogation data about one or more surgical devices from the cloud. Inthis example, a medical hub in a facility in Texas requests acommunication exchange with the cloud system 10000 for more data todetermine if the suspicious activity at one of its local hubs is trulyproblematic.

At block C reference 10006, the cloud authentication and security systemmay then be configured to perform additional data analysis to determinethe veracity of any threat and larger context of the nature of thissuspicious activity. In this example, the cloud-based security systemhas performed analysis and brings to light at least two pieces ofevidence of a security threat, which is expressed visually in the chartof block C. First, upon comparing the number of data requests andmedical interrogations across multiple medical facilities, it isdetermined that the current requesting facility in Texas has aninordinate number of data requests or medical interrogations compared toall other facilities. The cloud may be configured to flag this as onesecurity issue that needs to be addressed. Second, in comparison to thenumber of data requests, the number of suspicious data points orfindings is also inordinately high at the Texas facility. One or both ofthese realizations may prompt the cloud security system to enactdifferent security changes at the Texas facility in particular.

Thus, at block D reference 10008, in response to the identifiedanomalous behavior of the facilities in Texas as a whole, the cloudsecurity system may request additional data related to Texas to betterunderstand the nature of the practices and potential threats. Forexample, additional data regarding purchasing practices, vendors, thetype of surgical instruments being used, the type of surgical proceduresperformed in comparison to other facilities, and so forth, may beobtained from one or more surgical hubs at the Texas facility, or may beaccessed in data already stored in the cloud system 10000. The cloudsecurity system may be configured to look for additional anomalies andpatterns that may help determine how to change security proceduresspecific to the Texas facility, or the facilities in the Texas regiongenerally.

At block E reference 10010, once the additional information has beengathered and analyzed, the cloud security system may initiate a changedsecurity protocol for the Texas facility in particular that triggeredthis analysis from block A, as well as any new security procedures forany surgical devices that indicate a unique or above average threat. Forexample, it may be determined that a particular type of surgicaldevices, such as devices originating from a particular manufacturingfacility or having a particular set of unique identification numbers,may be faulty, pirated, or have some other kind of security risk. Thecloud system 10000 may have analyzed the suspicious data pointsoriginating from the Texas region, determined if there were anycommonalities or patterns, and issued a change in security protocolbased on these identified patterns. These devices may then be locked outfrom use at all surgical hubs, even if they are not connected to anysurgical hub at the present time. Other example changes regardingsecurity include modifying the types of data gathered to learn moreabout the types of threats or how widespread the threats are. Forexample, the suspicious activity in Texas may exhibit a certain patternor authentication signature of attempting to login in with the system,and so this pattern may be placed on an alert to other facilities inTexas and/or to other facilities to pay special attention to. In somecases, the pattern of suspicious activity may be correlated with anotherindicator, such as a brand or manufacturer, or a series of serialnumbers. The cloud system may send out alerts to those facilities knownto associate with these correlated indicators, such as all facilitiesthat utilize medical devices with the same manufacturer.

In addition, an augmented authentication procedure may be enacted at thelocalized Texas region. The cloud-security system may opt to performadditional authentication protocols for all devices originating out ofthe Texas facility, for example. These additional protocols may not bepresent or required at other facilities, since there is considered alower level of security risk based on the lack of suspicious activity.

In some aspects, as alluded to previously, the cloud-based securitysystem may also be configured to protect against unwanted intrusions,either to any hub or to the cloud system itself. This means that thesuspect medical device may be unable to access any data from any medicalhub, and may also be prevented from operating if it is connected to amedical hub. In a medical system utilizing the cloud system and multiplemedical hubs, the common protocol may require that only medical devicesconnected to a medical hub are authorized to operate on a patient, andtherefore the medical hub will have the capability of preventing adevice from activating. The limitation of any faulty or fraudulentsurgical device may be designed to protect a patient during a surgicalprocedure, and it can also be used to protect any surgical hub and thecloud itself. The same lockout procedure may be designed to stop bothscenarios from occurring.

In some aspects, the surgical hub may be configured to transmit data tothe cloud security system that better characterizes the nature of thesecurity flaws or intrusions. For example, the cloud security system maybe configured to store in memory the number of intrusion attempts, thesource of the intrusion attempt (e.g., from which surgical hub or evenwhat port or connection via the surgical hub), and what method forattempted intrusion there is, if any (e.g., virus attack, authenticationspoofing, etc.).

In some aspects, the cloud security system may also determine what typesof behaviors by a surgical device or other functions by a surgical hubare irregular, compared to a global average or just by each institution.The cloud security system may better identify what practices seemirregular in this way. The data logs of any surgical hub, or across anentire facility, may be recorded and securely stored in the cloudsystem. The cloud security system may then analyze the attempted accessrequests and actions to determine trends, similarities and differencesacross regions or institutions. The cloud security system may thenreport any irregularities to the institution and flag any identifiedirregularities for internal investigation into updates to protectagainst future breaches. Of note, a local hub or local facility withmultiple hubs may not realize if any of their authentication behaviorsare irregular, unless they are compared to a broader average orcomparison of other facilities. The cloud system may be configured toidentify these patterns, because it has access to authentication dataand procedures from these multiple facilities.

In some aspects, the cloud security system may be configured to analyzeany current hub control program versions and when it was updated. Thecloud security system may verify all updates are correct, and determinewhere their origins are. This may be an additional check to ensure thatthe software and firmware systems of the surgical devices are proper andhave not been tampered with.

In some aspects, the cloud security system may also determine largerthreats by analyzing multiple facilities at once. The system maydetermine, after aggregating data from multiple locations, any trends orpatterns of suspicious activity across a wider region. The securitysystem may then change security parameters across multiple facilitiesimmediately or in near real time. This may be useful to quickly react tosimultaneous attacks, and may make it even easier to solve simultaneousattacks by gathering data from the multiple attacks at once to betterincrease the chances and speed of finding a pattern to the attacks.Having the cloud system helps confirm whether attacks or suspiciousactivity occurs in isolation or is part of a grander scheme.

Data Handling and Prioritization

Aspects of the present disclosure are presented for a cloud computingsystem (computer-implemented interactive surgical system as describedabove) for providing data handling, sorting, and prioritization, whichmay be applied to critical data generated during various medicaloperations. The cloud computing system constitutes a cloud-basedanalytics system, communicatively coupled to a plurality of surgicalhubs 7006 and smart medical instruments such as surgical instruments7012. Typically, a healthcare facility, such as a hospital or medicalclinic, does not necessarily immediately recognize the criticality ofdata as it is generated. For example, if a medical instrument usedduring a perioperative period experiences a failure, the response ofmedical care facility personnel such as nurses and doctors may bedirected towards diagnosis of any medical complications, emergencymedical assistance, and patient safety generally. In this situation, thecriticality of the data might not be analyzed in a time sensitivemanner, or at all. Accordingly, the healthcare facility does notnecessarily timely respond to or even recognize critical data as suchdata is generated. Additionally, a particular healthcare facility canlack knowledge of the management of critical data from other similarlysituated facilities, either in its region, according to a similar size,and/or according to similar practices or patients, and the like. Thecloud-based analytics system may be specifically designed to addressthis issue of critical data and particularly the timing of data handlingthat is performed based on the criticality of data within the context ofhealthcare facility operations. The cloud-based analytics system mayquickly and efficiently identify critical data based on specificcriteria. In some situations, aggregate data is determined to becritical after the individual non-critical data comprising theaggregated data are aggregated. As used herein, handling critical data(which could be aggregated) may refer to data sorting, prioritizing, andother data handling based on specific criteria or thresholds.

To help facilitate timely and improved data sorting, handling, andprioritization, it would be desirable if a common source connected tomultiple healthcare facilities could sort, handle, and prioritizecritical data from these medical facilities in a holistic manner. Inthis way, insights could be generated by the common source based onusing this aggregated data from the multiple healthcare facilities. Invarious aspects, the cloud-based analytics system comprises the cloud7004 that is communicatively coupled to knowledge centers in a medicalfacility, such as one or more surgical hubs 7006, and is configured tosort, handle, and prioritize medical data from multiple healthcarefacilities. In particular, the cloud-based system can identify criticaldata and respond to such critical data based on the extent of theassociated criticality. For example, the cloud-based system couldprioritize a response as requiring urgent action based on the criticaldata indicating a serious perioperative surgical instrument 7012failure, such as one that requires intensive care unit (ICU)postoperative treatment. The data handling, sorting, and prioritizationdescribed herein may be performed by the processors 7008 of the centralservers 7013 of the cloud 7004 by, for example, executing one or moredata analytics modules 7034.

Critical data can be determined to be critical based on factors such asseverity, unexpectedness, suspiciousness, or security. Other criticalitycriteria can also be specifically selected such as by a healthcarefacility. Criticality can also be indicated by flagging a surgicalinstrument 7012, which in turn can be based on predetermined screeningcriteria, which could be the same or different as the factors describedabove. For example, a surgical instrument 7012 can be flagged based onits usage being correlated with severe post surgical operationcomplications. Flagging could also be used to trigger the prioritizeddata handling of the cloud-based analytics system. In connection with adetermination of criticality or flagging a surgical instrument 7012, thecloud 7004 can transmit a push message or request to one or moresurgical hubs 7006 for additional data associated with the use of thesurgical instrument 7012. The additional data could be used foraggregating data associated with the surgical instrument 7012. Forexample, after receiving the additional data, the cloud 7004 maydetermine there is a flaw in the surgical instrument 7012 (e.g.,malfunctioning generator in an energy surgical instrument) that iscommon to other corresponding surgical instruments 7012 in a particularhealthcare facility. Accordingly, the cloud 7004 could determine thatall such flawed surgical instruments 7012 should be recalled. Theseflawed surgical instruments 7012 might share a common identificationnumber or quality or a common aspect of a unique identifier, such as aserial number family identifier.

In general, the cloud-based analytics system may be capable ofaggregating, sorting, handling, and prioritizing data in a timely andsystematic manner that a single healthcare facility would not be able toaccomplish on its own. The cloud-based analytics system further canenable timely response to the aggregated, sorted, and prioritized databy obviating the need for multiple facilities to coordinate analysis ofthe particular medical data generated during medical operations at eachparticular facility. In this way, the cloud-based system can aggregatedata to determine critical data or flagging for enabling appropriateresponses across the entire network of surgical hubs 7006 andinstruments 7012. Specifically, appropriate responses include sorting,handling, and prioritization by the cloud 7004 according to a prioritystatus of the critical data, which can enable timely and consistentresponses to aggregated critical data (or critical aggregated data)across the entire network. Criticality of the data may be defineduniversally and consistently across all surgical hub 7006 andinstruments 7012. Furthermore, the cloud-based analytics system may beable to verify the authenticity of data from the plurality of medicalfacilities before such data is assigned a priority status or stored inthe aggregated medical data databases. As with the categorization ofcritical data, data verification can also be implemented in a universaland consistent manner across the system which a single facility may notbe able to achieve individually.

FIG. 198 is a flow diagram of the computer-implemented interactivesurgical system programmed to use screening criteria to determinecritical data and to push requests to a surgical hub to obtainadditional data, according to one aspect of the present disclosure. Inone aspect, once a surgical hub 7006 receives device data 11002 from asurgical instrument 7012 data may be flagged and/or determined to becritical based on predetermined screening criteria. As shown in FIG.198, the hub 7006 applies 11004 the screening criteria to flag devicesand to identify critical data. The screening criteria include severity,unexpectedness, suspiciousness, and security. Severity can refer to theseverity of any adverse medical consequences resulting from an operationperformed using the surgical instrument 7012. Severity could be assessedusing a severity threshold for surgical instrument 7012 failures. Forexample, the severity threshold could be a temporal or loss ratethreshold of bleeding such as over 1.0 milliliters per minute (mL/min).Other suitable severity thresholds could be used. Unexpectedness canrefer to a medical parameter of a deviation that exceeds a thresholdsuch as an amount of standard deviation from the mean medical parametervalue such as a determined tissue compression parameter significantlyexceeding the expected mean value at a time during an operation.

Suspiciousness can refer to data that appears to have been improperlymanipulated or tampered with. For example, the total therapeutic energyapplied to tissue value indicated by the data may be impossible given atotal amount energy applied via the generator of the surgical instrument7012. In this situation, the impossibility of the data suggests impropermanipulation or tampering. Similarly, security can refer to improperlysecured data, such as data including a force to close parameter that wasinadvertently deleted. The screening criteria also may be specified by aparticular surgical hub 7006 or by the cloud 7004. The screeningcriteria can also incorporate specific thresholds, which can be used forprioritization, for example. In one example, multiple severitythresholds can be implemented such that the extent of perioperativesurgical instrument 7012 failures can be sorted into multiple categoriesaccording to the multiple severity thresholds. In particular, themultiple severity thresholds could be based on the number of misalignedstaples from a stapling surgical instrument 7012 to reflect an extent ofthe severity of misalignment. By using the cloud-based analytic system,the cloud may systemically identify critical data and flag surgicalinstruments 7012 for providing a timely and appropriate response whichan individual healthcare facility could not achieve on its own. Thistimely response by the cloud 7004 can be especially advantageous forsevere post surgical operation complications.

Determining critical data and flagging the surgical instrument 7012 bythe hub 7006 may include determining a location to store data. Data maybe routed or stored based on whether the data is critical and whetherthe corresponding surgical instrument 7012 is flagged. For example,binary criteria can be used to sort data into two storage locations,namely, a memory of a surgical hub 7006 or the memory 7010 of the cloud7004. Surgical instruments 7012 generate this medical data and transmitsuch data, which is denoted as device data 11002 in FIG. 198, to theircorresponding surgical hub devices 7006. FIG. 198 illustrates an exampleof this binary sorting process. Specifically, in one aspect, the datarouting can be determined based on severity screening criteria as shownat the severity decision steps 11006, 11008. At step 11006, the hub 7006determines 11006 whether the surgical instrument 7012 that provided thedevice data 11002 has experienced a failure or malfunction duringoperation at the perioperative stage and whether this failure isconsidered severe. The severity thresholds discussed above or othersuitable means could be used to determine whether the failure is severe.For example, severe failure may be determined based on whetherundesirable patient bleeding occurred during use or firing of thesurgical instrument. If the determination at step 11006 is yes, thecorresponding data (i.e., critical data) of the surgical instrument 7012is transmitted 11012 by the hub 7006 to the cloud 7004. Conversely, ifthe determination at step 11006 is no, the flow diagram may proceed tostep 11008.

If the determination at step 11006 is no, then the flow diagram proceedsto step 11008 in FIG. 198, where the surgical hub 7006 determineswhether the patient transitioned to nonstandard post-operation care(i.e. the ICU) after the operation was performed with the specificsurgical instrument 7012. However, even if the determination at step11006 is no, the inquiry at step 11008 may still be performed. If thedetermination at step 11008 is yes, then the critical device data 11002is transmitted to the cloud 7004. For example, the determination at step11008 is yes if a patient transitioned into the ICU from the operatingroom subsequent to a routine bariatric surgical procedure. Upon transferof a patient into the ICU, the surgical hub 7006 may receive a timelysignal from the surgical instrument 7012 used to perform the bariatricprocedure indicating that the patient has experienced complicationsnecessitating entry into the ICU. Since this signal indicates the step11008 determination is yes, corresponding device data 11002 is sent11012 to the cloud 7004. Additionally, the specific surgical instrument7012 may be flagged by the cloud 7004 for a prompt specific response bythe cloud 7004, such as designating the surgical instrument 7012 with aprioritization of requiring urgent action. If the determination at step11008 is no, a signal can be transmitted from the surgical instrument7012 to the surgical hub 7006 indicating that the procedure wassuccessful. In this scenario, the device data 11002 can be stored 11010locally in a memory device of the surgical hub 7006.

Additionally or alternatively, the specific surgical instrument 7012 mayalso be flagged by the hub 7006 or the cloud 7004 to trigger datahandling by the cloud 7004, which can comprise an internal response ofthe cloud 7004. When the surgical instrument 7012 is flagged or thedevice data 11002 is determined to be critical, the triggered responsemay be the cloud 7004 transmitting a signal comprising a request foradditional data regarding the surgical instrument 7012. Additional datamay pertain to the critical device data 11002. The cloud 7004 can alsorequest additional data even if the specific surgical instrument 7012 isnot flagged, such as if the device data 11002 is determined to becritical without the surgical instrument 7012 being flagged. Flaggingcould also indicate an alarm or alert associated with the surgicalinstrument 7012. In general, the hub 7006 is configured to executedetermination logic for determining whether the device data 11002 shouldbe sent to the cloud 7004. The determination logic can be consideredscreening criteria for determining criticality or flagging surgicalinstruments 7012. Besides the severity thresholds used at steps decisionsteps 11006, 11008, the data routing can be based on frequencythresholds (e.g., the use of a surgical instrument 7012 exceeds a usagequantity threshold such as a number of times an energy generator isused), data size thresholds, or other suitable thresholds such as theother screening criteria discussed above. Flagging may also result instoring a unique identifier of the specific surgical instrument in adatabase of the cloud-based system.

A triggered request 11014 for additional data by the cloud 7004 to thehub 7006 may be made based on a set of inquiries as shown in FIG. 198.This triggered request 11014 may be a push request sent by the centralservers 7013 of the cloud 7004. In particular, the processors 7008 canexecute the data collection and aggregation data analytic module 7022 toimplement this trigger condition functionality. This push request maycomprise an update request sent by the cloud 7004 to the hub 7006 toindefinitely collect new data associated with the device data 11002.That is, the hub 7006 may collect additional data until the cloud 7004transmits another message rescinding the update request. The pushrequest could also be a conditional update request. Specifically, thepush request could comprise initiating a prompt for the hub 7006 to sendadditional information only if certain conditions or events occur. Forexample, one condition might be if the sealing temperature used by thesurgical instrument 7012 to treat tissue exceeds a predeterminedthreshold. The push request could also have a time bounding component.In other words, the push request could cause the surgical hub 7006 toobtain additional data for a specific predetermined time period, such asthree months. The time period could be based on an estimated remaininguseful life of the surgical instrument 7012, for example. As discussedabove, the request 11014 for additional data may occur after thespecific surgical instrument 7012 is flagged, which may be due to anaffirmative determination at steps 11006, 11008 described above.

As shown in FIG. 198, the triggered request 11014 for additional datamay include four inquiries that can be considered trigger conditions foradditional information. At the first inquiry, the hub 7006 determines11016 whether the device data 11002 represents an outlier with no knowncause. For example, application of therapeutic energy to tissue during asurgical procedure by the surgical instrument 7012 may cause patientbleeding even though surgical parameters appear to be within a normalrange (e.g., temperature and pressure values are within expected range).In this situation, the critical device data 11002 indicates anirregularity without a known reason. The outlier determination 11016 canbe made based on comparison of the device data 11002 to an expectedvalue or based on a suitable statistical process control methodology.For example, an actual value of the device data 11002 may be determinedto be an outlier based on a comparison of the actual value to a meanexpected (i.e., average) value. Calculating that the comparison isbeyond a certain threshold can also indicate an outlier. For example, astatistical process control chart could be used to monitor and indicatethat the difference between the actual and expected value is a number ofstandard deviations beyond a threshold (e.g., 3 standard deviations). Ifthe device data 11002 is determined to be an outlier without a knownreason, the request 11014 is triggered by the cloud 7004 to the hub7006. In response, the hub 7006 timely transmits 11024 additionalinformation to the cloud 7004, which may provide different, supporting,or additional information to diagnose the reason for the outlier. Otherinsights into the outlier may also be derived in this way. For example,the cloud 7004 may receive additional surgical procedure parameterinformation such as the typical clamping force used by other surgicalinstruments 7012 at the same point in the surgical procedure when thepatient bleeding occurred. The expected value may be determined based onaggregated data stored in the aggregated medical data database 7012,such as by averaging the outcomes or performance of groups of similarlysituated surgical instruments 7012. If at step 11016, the data is notdetermined to be an outlier, the flow diagram proceeds to step 11018.

The second inquiry is another example of a trigger condition. At step11018, the hub 7006 determines 11018 whether device data 11002 involvesdata that can be classified as suspicious, which can be implemented bythe authorization and security module 7024. For example, suspicious datamay include situations in which an unauthorized manipulation isdetected. These include situations where the data appears significantlydifferent than expected so as to suggest unauthorized tampering, data orserial numbers appear to be modified, security of surgical instruments7012 or corresponding hub 7006 appears to be comprised. Significantlydifferent data can refer to, for example, an unexpected overall surgicaloutcome such as a successful surgical procedure occurring despite asurgical instrument 7012 time of usage being significantly lower thanexpected or a particular unexpected surgical parameter such as a powerlevel applied to the tissue significantly exceeding what would beexpected for the tissue (e.g., calculated based on a tissue impedanceproperty). Significant data discrepancies could indicate data or serialnumber modification. In one example, a stapling surgical instrument 7012may generate a separate unique staple pattern in a surgical operationwhich may be used to track or verify whether the serial number of thatstapling surgical instrument 7012 is subsequently modified. Furthermore,data or serial number modification such as tampering may be detected viaother associated information of a surgical instrument 7012 that can beindependently verified with the aggregated medical data databases 7011or some other suitable data modification detection technique.

Moreover, compromised security, such as unauthorized or irregular accessto any surgical hub 7006 or other protected data sets stored within thecloud 7004 can be detected by a cloud-based security and authenticationsystem incorporating the authorization and security module 7024. Thesecurity and authentication system can be a suitable cloud basedintrusion detection system (IDS) for detecting compromised security orintegrity. The cloud IDS system can analyze the traffic (i.e. networkpackets) of the cloud computing network 7001 or collect information(e.g., system logs or audit trails) at various surgical hub 7006 fordetecting security breaches. Compromised security detection techniquesinclude comparison of collected information against a predefined set ofrules corresponding to a known attack which is stored in the cloud 7004and anomaly based detection. The cloud 7004 can monitor data from aseries of surgical operations to determine whether outliers or datavariations significantly reduce without an apparent reason, such as areduction without a corresponding change in parameters of used surgicalinstruments 7012 or a change in surgical technique. Additionally,suspiciousness can be measured by a predetermined suspiciousness orunexpectedness threshold, unauthorized modification of device data11002, unsecure communication of data, or placement of the surgicalinstrument 7012 on a watch list (as described in further detail below).The suspiciousness or unexpectedness threshold can refer to a deviation(e.g., measured in standard deviations) that exceeds surgical instrument7012 design specifications. Unauthorized data communication ormodification can be determined by the authorization and security module7024 when the data encryption of the cloud 7004 is violated or bypassed.In sum, if the hub 7006 determines 11018 the data is suspicious for anyof the reasons described above, the request 11014 for additional datamay be triggered. In response, the hub 7006 timely transmits 11024additional information to the cloud 7004, which may provide different,supporting, or additional information to better characterize thesuspiciousness. If at step 11018, the answer to the second inquiry isno, the flow diagram proceeds to step 11020.

The third and fourth inquiries depict additional trigger conditions. Atstep 11020, the hub 7006 may determine that device data 11002 indicatesa unique identifier of the surgical instrument 7012 that matches anidentifier maintained on a watchlist (e.g., “black list” of prohibiteddevices). As described above, the “black list” is a watch list that canbe maintained as a set of database records comprising identifierscorresponding to prohibited surgical hubs 7006, surgical instruments7012, and other medical devices. The black list can be implemented bythe authorization and security module 7024. Moreover, surgicalinstruments 7012 on the black list may be prevented from fullyfunctioning or restricted from access with surgical hubs 7006. Forexample, an energy surgical instrument 7012 may be prevented fromfunctioning (i.e. an operational lockout) via the cloud 7004 or surgicalhub 7006 transmitting a signal to the hub 7006 or surgical instrument7012 to prevent the generator from applying power to the energy surgicalinstrument 7012. This operational lockout can generally be implementedin response to an irregularity indicated by the critical device data11002. Surgical instruments can be included on the black list for avariety of reasons such as the authorization and security module 7012determining the presence of counterfeit surgical instruments 7012 usinginternal authentication codes, unauthorized reselling of surgicalinstruments 7012 or related products from one region to another,deviation in performance of surgical instruments 7012 that isnonetheless within design specifications, and reuse of surgicalinstruments 7012 or related products that are designed for singlepatient use. For example, internal authentication codes may be uniqueidentifiers maintained by the cloud 7004 in the memory devices 7010.Other unauthorized usage could also result in placement on the blacklist.

The use of counterfeit authentication codes may be a security breachthat is detectable by the cloud IDS system. Reselling of surgicalinstruments 7012 into other regions could be detected via regionspecific indicators of resold surgical instrument 7012 or surgical hubs7006, for example. The region specific indicator could be encryptedusing a suitable encryption technique. In this way, the cloud 7004 maydetect when the region specific indicators of a resold surgicalinstrument 7012 do not match the corresponding region of intended use.Reuse of a single use surgical instrument 7012 can be monitored bydetecting tampering with a lockout mechanism (e.g., a stapler cartridgelockout mechanism of a stapling surgical instrument), programming amicroprocessor of the single use surgical instrument 7012 to transmit awarning signal to the corresponding surgical hub 7006 when more than oneuse occurs, or another suitable detection technique. Performancedeviation could be monitored using statistical process control methodsas described above. The design specifications of particular surgicalinstruments 7012 may be considered the control limits of a statisticalprocess control methodology. In one example, when detected by the cloud7004, a significant trend toward one of the lower or upper controllimits constitutes a sufficient deviation that results in the cloud 7004adding the corresponding surgical instrument to the black list. Asdiscussed above, a deviation that exceeds design specifications mayresult determining 11018 the device data 11002 is suspicious. Surgicalinstruments 7012 may be added to or removed from the black list by thecloud 7004 based on analysis of the requested additional data. In sum,if the hub 7006 determines 11020 the surgical instrument 7012corresponding to the device data 11002 is on the watchlist, the request11014 for additional data may be triggered. In response, the hub 7006timely transmits 11024 additional information to the cloud 7004, whichmay provide different, supporting, or additional information. If at step11020, the answer to the second inquiry is no, the flow diagram proceedsto step 11022.

The trigger condition at step 11022 comprises the hub 70006 determiningwhether the device data 11002 indicates the surgical instrument 7012 hasmalfunctioned. In one aspect, a surgical instrument 7012 malfunctionresults in an automated product inquiry through the correspondingsurgical hub 7006. The hub 7006 sending 11024 additional data to thecloud 7004 may comprise all pertinent data of the surgical instrument7012 being immediately transmitted to the cloud through the surgical hub7006, which may result in central server 7013 processors 7008 of thecloud 7004 executing an automated product inquiry algorithm. However,such an algorithm may not be immediately executed or at all if themalfunction is not significant. The cloud 7004 may be configured torecord this set of pertinent data for all surgical instruments 7012 forcontingent use when such automated product inquiries are instituted. Theautomated product inquiry algorithm comprises the cloud 7004 searchingfor previous incidents that are related to the malfunction. The cloud7004 may populate a group of records in the aggregated medical datadatabases 7011 with any incidents or activity related to themalfunction. Subsequently, a corrective and preventive action (CAPA)portion of the algorithm may be instituted for reducing or eliminatingsuch malfunctions or non-conformities. CAPA and the automated productinquiry algorithm are one example of a possible internal response 11102of the cloud 7004 of the cloud-based analytics system.

CAPA involves investigating, recording and analyzing the cause of amalfunction or non-conformity. To implement CAPA, the cloud 7004 mayanalyze the populated related records in the aggregated medical datadatabases 7011, which may include aggregated data fields such assurgical instrument 7012 manufacture dates, times of use, initialparameters, final state/parameters, and surgical instrument 7012 numbersof uses. Thus, both individual and aggregated data maybe used. In otherwords, the cloud 7004 may analyze both individual data corresponding tothe malfunctioning surgical instrument 7012 as well as aggregated data,collected from all related surgical instruments 7012 to themalfunctioning surgical instrument 7012, for example. Initial and finalparameters may be, for example, an initial and final frequency of anapplied RF signal of the surgical instrument. CAPA can also involveanalysis of the previous time period from when the malfunction occurredor was detected. Such a time period can be, for example, one to twominutes. Based on this CAPA analysis, the cloud 7004 may diagnose theroot cause of the malfunction and recommend or execute any suitablecorrective action (e.g., readjusting miscalibrated parameters). Theautomated product inquiry algorithm can also involve a longer follow upof patient outcomes for patients treated with the specific surgicalinstrument 7012.

For example, the cloud 7004 may determine a priority status of watchlist for the surgical instrument 7012 so that the surgical instrument7012 may be monitored for a period of time after the malfunction isdetected and addressed. Moreover, the malfunction may cause the cloud7004 to expand a list of medical items to be tracked (e.g., theintegrity of tissue seals made during surgery). This list of items to betracked may be performed in conjunction with the patient outcomemonitoring by the patient outcome analysis module 7028. The cloud 7004may also respond to an irregularity indicated by the malfunction bymonitoring patient outcomes corresponding to the irregularity. Forexample, the cloud 7004 can monitor whether the irregularity correspondsto unsuccessful surgical operations for a predetermined amount of timesuch as 30 days. Any corrective action also can be assessed by the cloud7004. Other data fields can also be monitored in addition to the fieldsdiscussed above. In this way, the cloud may timely diagnose and respondto surgical instrument 7012 malfunctions using individual and aggregatedata in a manner that an individual healthcare facility could notachieve.

In one aspect, if the answer to any of steps 11016, 11018, 11020, 11022(i.e. trigger conditions) is affirmative (i.e. the trigger condition isactivated), then additional data associated or pertinent to the devicedata 11002 is sent to the cloud 7004, as can be seen in FIG. 198. Thisadditional data may be handled by the data sorting and prioritizationmodule 7032 while the patient outcome analysis module 7028 may analyzethe data, for example. In contrast, if the answer to all of steps 11016,11018, 11020, 11022 is negative, then the respective data is stored11026 within the corresponding surgical hub 7006. Thus, when the answerat step 11022 is no, the device data 11002 may be stored locally withinthe hub 7006 and no additional data is requested of the hub 7006.Alternatively, the device data may be sent to the cloud 7006 for storagewithin the memory devices 7010, for example, without any triggeredrequests 11014 by the cloud 7004 for additional data. Steps 11016,11018, 11020, 11022 could also be used for identifying critical data orflagging the surgical instrument (if the specific surgical device hasnot already been flagged based on steps 11006, 11008) as part of thescreening criteria applied at step 11004. Other trigger conditions asidefrom steps 11016, 11018, 11020, 11022 are also possible for triggeringthe request 11014 for additional data. The request can be sent to allsurgical hubs 7006 or a subset thereof. The subset can be geographicallyspecific such that, for example, if surgical hub 7006 used in healthcarefacilities located in Illinois and Iowa have malfunctioned in a similarmanner, only surgical hub 7006 corresponding to healthcare facilities inthe Midwestern United States are requested 11014 for additionalinformation. The requested additional data can be different orsupporting data concerning the particular use of surgical instruments7012 so that the cloud 7004 may gain additional insight into the sourceof the irregularity, as represented by steps 11016, 11018, 11020, 11022.For example, if malfunctioning surgical instruments 7012 are causingundesirable patient bleeding, the cloud 7004 may request timinginformation regarding this bleeding for help in potentially diagnosingwhy the malfunction is causing the bleeding.

The criticality of data can be identified based on the screeningcriteria as described above, or by any other suitable data analysistechnique. In one aspect, as shown in FIG. 199, when the critical datais determined, an internal analytic response 11102 of the cloud 7004 maycommence. The internal analytic response 11102 can advantageously bemade in a timely manner such as in real time or near real time. Asdiscussed above, the criticality of data can be identified based on theseverity of an event, the unexpected nature of the data, thesuspiciousness of the data, or some other screening criteria (e.g., aninternal business flag). The determination of critical data can involvea request generated by a surgical hub 7006 based on the surgical hub7006 detecting an irregularity or failure of a corresponding surgicalinstrument 7012 or of a component of the surgical hub 7006 itself. Therequest by the surgical hub 7006 may comprise a request for a particularprioritization or special treatment of critical data by the cloud 7004.In various aspects, the cloud internal analytic response 11102 could beto escalate an alarm or response based on the frequency of the eventassociated with the critical device data 11002, route the device data11002 to different locations within the cloud computing system, orexclude the device data 11002 from the aggregated medical data databases7011. In addition, the cloud 7004 could also automatically alter aparameter of a malfunctioning surgical instrument 7012 so thatmodifications for addressing the malfunction can be implemented in realtime or near real time. In this manner, even malfunctions that are notreadily detected by a clinician in a healthcare facility, for example,may still be advantageously addressed in a timely manner by the cloud7004.

FIG. 199 is a flow diagram of an aspect of responding to critical databy the computer-implemented interactive surgical system, according toone aspect of the present disclosure. In particular, the internalanalytic response 11102 by the cloud 7004 can include handling criticaldata which includes determining a priority status to determine a timecomponent or prioritization of the response. The response 11102 itselfmay be based on an operational characteristic indicated by the criticaldata, such as the characteristics described above in connection with thescreening criteria or the trigger conditions of FIG. 198. The internalresponse 11102 may be implemented by the data sorting and prioritizationmodule 7032 as well as the data collection and aggregation module 7022.As shown in FIG. 199, in the prioritization branch of the flow diagram(labeled as Q1 in FIG. 199) the cloud may incorporate the binarydecision of whether to exclude the critical data from the aggregatedmedical data databases 7011 with a priority escalation decisionframework. At step 11104 of FIG. 199, the cloud 7004 determines whetherthe critical data should be excluded from the aggregated medical datadatabases 7011. The exclusion determination may be considered athreshold determination.

It can be desirable to exclude critical data from the aggregated medicaldata databases 7011 for verification purposes. For example, criticaldata that is flagged or designated for special routing may be placed ona hold list maintained by the cloud 7004. The hold list is maintained ata separate storage location in the memory 7010 relative to theaggregated medical data databases 7011 within the cloud 7004, such asthe caches 7018. The excluded critical data could also be stored in amore permanent storage location in the memory 7010. Accordingly, if theanswer to step 11104 is yes, the cloud 7004 stores 11118 the criticaldata in the hold list. The cloud 7004 may then validate or verify thatthe critical device data 11002 is accurate. For example, the cloud 7004may analyze whether the device data 11002 is logical in light of acorresponding patient outcome or analyze additional associated data ofthe device data 11002. Upon proper verification, the device data 11002may also be stored within the aggregated medical data databases 7011.But if the device data 11002 is not verified, the cloud 7004 may notinclude the unverified device data 11002 in the priority escalationdecision framework. That is, before verification, the device data 11002may not be assigned a priority status according to the priority statusclassification 11106 for the internal cloud response 11102.

However, if the device data 11002 is verified, the flow diagram mayproceed to the priority status classification 11106. Accordingly, if theanswer to the exclusion determination at step 11104 is no, the devicedata 11002 is prioritized according to the priority escalation decisionframework, which can define a predetermined escalation method forhandling critical data. As shown in FIG. 199, a predetermined escalationprioritization system 11106 (i.e., priority escalation decisionframework) can comprise four categories, including watch list, automatedresponse, notification, and urgent action required. This predeterminedescalation prioritization system 11106 can be considered a form oftriage based on classifying critical data according a priority statusand escalating between statuses based on particular thresholds. Forexample, priority can be escalated based on a frequency of eventthreshold such as the number of misaligned staples fired by a staplingsurgical instrument 7012 over a predetermined number of surgicaloperations. Multiple staggered frequency or other thresholds could alsobe used. The lowest priority level of the priority status classification11106 is the watch list level designated at level A. As discussed above,the watch list may be a black list maintained in the memory 7010 as aset of database records of identifiers corresponding to prohibitedsurgical hubs 7006. Surgical hubs 7006 can be prohibited to differentextents depending on the nature of the critical device data 11002 oradditional data. For example, surgical hubs 7006 may be partially lockedout such that only the device components experiencing problems areprevent from functioning. Alternatively, surgical hub 7006 on the watchlist may not be restricted from functioning in any way. Instead, thesurgical hubs 7006 may be monitored by the cloud 7004 for any additionalirregularities that occur. Accordingly, the watch list is designated atlevel A, the least urgent priority status. As shown in the prioritystatus classification 11106, the automated response at level B is thenext most urgent priority status. An automated response could be, forexample, an automated initial analysis of the device data 11002 by thepatient outcome analysis module 7028 of the cloud 7004 via a set ofpredefined diagnostic tests.

The third most urgent priority status is notification, which isdesignated at level C of the priority status classification 11106. Inthis situation, the cloud 7004 transmits a wireless signal to ahealthcare facility employee, clinician, healthcare facility department,or other responsible party depending on the nature of the device data11002. The notification signal can be received at a receiver devicelocated at a suitable location within the healthcare facility, forexample. Receiving the notification signal can be indicated by avibration or sound to notify the responsible party at the healthcarefacility. The holder of the receiver device (e.g., a healthcare facilityclinician) may then conduct further analysis of the critical device data11002 or additional data or other analysis for resolving an indicatedirregularity. If a solution to the irregularity is known, the solutionmay be timely implemented. The most urgent priority status as depictedin the priority status classification 11106 is urgent action required,which is designed at level D. Urgent action required indicates that aresponsible party, device or instrument should immediately analyze anddiagnose the problem implicated by the critical data. Upon properdiagnosis, an appropriate response should immediately be performed. Inthis way, the cloud 7004 may implement a comprehensive approach tocritical data prioritization and triaging that no individual medicalfacility could achieve on its own. Critical data may be handled in atimely manner according to suitable priority levels which can addresssolving time sensitive problems that arise in the healthcare field.Moreover, the cloud 7004 can prioritize aggregated critical data fromall healthcare facilities categorized within a particular region.Accordingly, the time sensitive prioritized approach to handlingcritical data can be applied system wide, such as to a group ofhealthcare facilities. Furthermore, the cloud 7004 can generate an alertfor a responsible party to respond to critical data (and associatedissues implicated by such critical data) in a timely way such as in realtime or in near real time according to a corresponding priority status.This alert can be received by a suitable receiver of the responsibleparty. The priority status of the device data 11002 could also bedetermined based on the severity of the surgical issue implicated by thedevice data 11002. As discussed above, the cloud 7004 may receiveadditional data from surgical hubs 7006 or surgical instruments 7012(via the hubs 7006) which causes the cloud 7004 to elevate the prioritystatus of the device data 11002.

In one aspect, based on a priority status, the device data 11002 may besubject to the flagging screening at a specific time depending onpriority. For example, the device data 11002 may be indicated ascritical data but not yet flagged. Additionally, the device data 11002may first receive an automated response level of priority according tothe priority status classification 11106. In this situation, theseverity determination at step 11108 may be relatively quickly inaccordance with the level B of priority. Specifically, step 11108 may bereached without first placing the surgical instrument 7012 on a watchlist. The severity threshold used at step 11108 can be the same ordifferent from the severity threshold used in 11006. Aside from theseverity determination at step 11108, other determinations pertinent tothe irregularity indicated by the critical device data 11002 oradditional data may be made. These determinations may be used todiagnose the occurrence of a critical event. Accordingly, if the answerat step 11108 is yes, the frequency of the event may be assessed at step11110. Conversely, if the answer at step 11108 is no, the device data11002 or additional data can be stored 11118 in the hold list.Additionally or alternatively, the device data 11002 or additional datacan be routed to different storage locations within the cloud 7004according to the routing branch of the flow diagram (labeled as Q2 inFIG. 199). The cloud 7004 may wait for a request from the hub 7006 foralternative routing 11120 of the device data 11002 or additional data.At step 11110, the cloud 7004 determines the frequency that the criticalevent is occurring. Based on this frequency, the priority statusassigned according to the priority status classification 11106 can beescalated (see step 11116). For example, the critical event may be thegenerator of the surgical instrument 7012 is applying an insufficientsealing temperature to therapeutically treat tissue. In other words, theinquiry of step 11110 inquires whether the medical event implicated bythe critical data is occurring at an increasing frequency after theproblem was initially identified.

An increase in the number of times this insufficient sealing temperatureoccurs can be monitored to escalate priority status at step 11116, basedon frequency thresholds (see step 11112), for example. If at step 11110,the event is not increasing in frequency, the data can be stored 11118in the hold list. If the answer at step 11110 is yes (i.e., the event isincreasing in frequency), the flow diagram proceeds to step 11112. Atstep 11112, another data verification inquiry is made. In particular,specific thresholds such as the frequency thresholds described above maybe applied to determine whether the combination of device data 11002 oradditional data is sufficiently correct to ensure that the critical datashould be added to the aggregated medical data databases 7011.Furthermore, the data verification inquiry at step 11112 may comprise adecision regarding whether the sample size of the critical data issufficiently large (i.e., reached critical mass). Additionally oralternatively, the sample size is analyzed for whether there issufficient information to determine an appropriate internal response11102 of the cloud 7004. The data verification inquiry can also compriseverifying the accuracy of the data by comparison to predeterminedstandards or verification tests. If the answer to the inquiry at step11112 is negative, then the critical data is stored within the separatestorage location (e.g., hold list) in the cloud 7004. If the answer tothe inquiry at step 11110 is affirmative, the device data 11002 oradditional data is added to the aggregated medical data databases 7011.At step 11116, the priority status of the device data 11002 oradditional data is increased according to the priority statusclassification 11106. However, besides the event frequencydetermination, the addition to the aggregated medical data databases7011 may itself be an action that results in an elevation of thepriority status of the critical data at step 7. In any case, thepriority status of the device data 11002 or additional data may beescalated or deescalated as appropriate based on additional analysis ordata, for example. An internal response 11102 of the cloud 7004 may bemade according to the current priority status (i.e., one of levels A-D)of the critical data.

In addition to prioritizing critical data, the internal response 11102of the cloud 7004 can also involve advantageously routing, grouping, orsorting critical data the aggregated critical data in a timely manner.In particular, the data may be routed to different storage locationswithin the cloud 7004, such as in the memory devices 7010. This routingis illustrated by routing branch of the flow diagram labeled as Q2 inFIG. 199 at step 11120. As such, the memory devices 7010 of the centralservers 7013 of the cloud 7004 can be organized into various locationsthat correspond to a characteristic of the critical data or a responsecorresponding to the critical data. For example, the total memorycapability of the memory devices 7010 may be divided into portions thatonly store data according to individual data routing categories, such asthose used at steps 11122, 11124, 11126. As shown at step 11120 of FIG.199, the critical data may be routed to different various cloud storagelocations. Step 11120 can occur in conjunction with or separately fromthe prioritization branch of the flow diagram. Step 11120 may betriggered by a request generated by a hub 7006. The hub 7006 maytransmit such a request because of detecting a failure or irregularityassociated with a surgical instrument 7012, for example. The associatedcritical data may then receive alternative routing 11120 by the cloud7004 to different cloud storage locations. At step 11122, thealternative routing 11120 can comprise geographical location basedrouting. That is, the different cloud storage locations may correspondto location based categorization of the cloud memory devices 7010.Various subsets of the cloud memory devices 7010 can correspond tovarious geographical regions. For example, surgical instruments producedfrom a manufacturing plant in Texas could be grouped together in storagewithin the cloud memory devices 7010. In another example, surgicalinstruments produced from a specific manufacturing company can becategorized together in the cloud memory devices 7010. Therefore,location based categorization can comprise the cloud 7004 routingcritical data based on associations with different manufacturing sitesor operating companies.

At step 11124, the alternative routing 11120 can comprise routing fordevice data 11002 or additional data that requires a rapid internalresponse 11102 of the cloud 7004. This alternative routing 11120 at step11124 could be integrated with the priority status classification 11106.For example, escalated or urgent priority critical data, such as thoseat priority level C and D, may be routed by the cloud 7004 to rapidresponse portions of the memory devices 7010 to enable a rapid response.For example, such critical data may be routed to rapid response caches7018 which signifies that a rapid response is necessary. At step 11126,device data 11002 or additional data that implicates a failure of a typethat requires special processing are routed to a special processingportion of the memory devices 7010. For example, a surgical instrument7012 may be determined to have experienced a failure or malfunctionduring operation based on a control program deficiency common to a wholegroup of surgical instruments 7012. In this situation, specialprocessing may be required to transmit a collective control programupdate to the group of surgical instruments 7012. Accordingly, the cloudmay route the critical data to the special processing portion of thememory devices 7010 to trigger this special processing. Subsequently,the special processing could also include the patient outcome analysisdata analytics module 7028 analyzing and monitoring the effect of thecontrol program update on patient outcomes. The patient outcome analysismodule 7028 may also execute an automated product inquiry algorithm asdiscussed above if necessary.

FIG. 200 is a flow diagram of an aspect of data sorting andprioritization by the computer-implemented interactive surgical system,according to one aspect of the present disclosure. This sorting andprioritization may be implemented by the data sorting and prioritizationmodule 7032, the data collection and aggregation module 7022, andpatient outcome analysis module 7028. As discussed above, criticaldevice data 11002 or additional data can implicate or correspond tovarious medical events, such as events 1 through 3 as depicted in FIG.200. An event may be for example, a shift from a phase of tissuetreatment to another phase such as a shift from a phase corresponding tocutting with the specific surgical instrument to a phase correspondingto coagulation. In FIG. 200, critical data associated with a firstmedical event 11202 is detected by the surgical hub 7006 and transmittedto the cloud 7004. Upon receiving the critical data, the cloud 7004analyzes the critical data at step 11208 to determine that it iscomparable to an expected value of the critical data, as described abovefor example at step 11016. When the critical data is determined ascomparable (i.e., the value of the critical data is expected), thecritical data may be aggregated within a large data set in theaggregated medical data databases 7011, for example. That is, at step11216, the critical data is stored within the aggregated databases ofthe cloud. As shown in FIG. 200, the critical data is also subject to abinary classification at steps 11218, 11220. For example, the criticaldata can be distinguished by good properties and bad properties. Thedata sorting and prioritization modules can classify the critical dataas associated with a bleeding or a non-bleeding event, for example. Inthis way, the patient outcome analysis module 7028 may classify criticaldata as corresponding to a positive patient outcome at step 11218 or anegative patient outcome at step 11210.

FIG. 200 also shows the critical data associated with a second medicalevent 11204 is detected by the surgical hub 7006 and transmitted to thecloud 7004. The critical data associated with the second medical event11204 is determined by the cloud to be suspicious or unusual data atstep 11210, which is a trigger condition as described above withreference to step 11118. Accordingly, the cloud 7004 is triggered torequest 11114 additional data from the surgical hub 7006 at step 11212by transmitting a push message to the surgical hub 7006. As discussedabove, the additional data may enable the patient outcome analysismodule 7028 of the cloud 7004 to gain additional insight into the sourceof the irregularity implicated by the critical data. If the patientoutcome analysis module 7028 sufficiently diagnoses the cause of thesecond medical event 11214, the critical data or associated additionaldata is aggregated into the aggregated medical data databases 7011 atstep 11216 (see also step 11114). Subsequently, the critical data oradditional data is classified according to the good/bad binaryclassification at steps 11218, 11220. If the cloud 7004 cannotsufficiently diagnose the cause of the second medical event 11204, theprocess may proceed to step 11224, in which the critical data isevaluated by a suitable person or department of the correspondingmedical facility. Step 11224 can include the threshold data exclusiondetermination at step 11104. That is, because a good reason cannot bereadily determined for the suspicious or unusual data, the data may bestored in a hold list in accordance with step 11118. Additionally, thedevice data 11002 or additional data may be designated at prioritystatus level C, which triggers the evaluation at step 11224 (i.e.,healthcare facility employee, clinician, healthcare facility department,or other responsible party evaluates the data).

As illustrated in FIG. 200, the critical data associated with a thirdmedical event 11206 is detected by the surgical hub 7006 and transmittedto the cloud 7004. The critical data associated with the third medicalevent 11206 is determined by the cloud 7004 to indicate that thecorresponding surgical instrument 7012 is experiencing a failure ormalfunction at step 11220. As discussed above, severity thresholds canbe used to determine whether the failure is severe. The failure ormalfunction may refer back to the trigger condition at step 11022 inFIG. 198 such that the surgical instrument malfunction results in anautomated product inquiry through the surgical hub 7006. As discussedabove, the automated product inquiry algorithm may comprise the patientoutcome analysis module 7028 searching for data of related incidentsstored within the cloud 7004 (e.g., the memory devices 7010). The dataof related incidents can include video, manufacturer, temporal, andother suitable types of data. Depending on the results of the automatedproduct inquiry, the third medical event 11206 critical data can beprioritized according to priority status classification 11106. Thus, forexample, the inquiry may result in a suspicious or unusual resultwithout a sufficient reason, so the critical data is designated atpriority level C. In this connection, a suitable person or department ofthe corresponding medical facility evaluates the critical data and theresults of the automated product inquiry at step 11224. The results ofthe evaluation could be, for example, that the results constitute anerror to be disregarded at step 11226 or that the results requireadditional special processing via the patient outcome analysis module7028 at step 11228 (see also step 11126). Such special processing atstep 11228 can be the CAPA portion of the automated product inquiryalgorithm, as described above. Thus, the cloud-based analytics systemmay generate timely alerts for triggering a response by the suitableperson or department in real time or near real time.

In general, the cloud-based analytics system described herein maydetermine critical data and perform timely data handling, sorting, andprioritizing based on priority status and specific thresholds asdescribed above. Accordingly, the cloud-based analytics systemadvantageously handles critical data in a timely, systematic, andholistic manner over multiple health care facilities. The critical datahandling comprises internal responses by the cloud 7004 based onassigned priority levels. Moreover, based on requests by surgical hubs7006, special routing of data within the memory device 7010 of the cloud7004 may be achieved. The rerouting, prioritizing, confirming, orrequesting supporting as described above may be used to improve analysisof the data by the cloud 7004.

Cloud Interface for Client Care Institutions

All client care institutions require some level of control in atreatment environment. For example, an institution may wish to controlinventory that is present within an operating room. Inventory itemswithin an operating room may include not only medical devices to be usedduring surgery (e.g., scalpels, clamps, surgical tools, etc.) but alsomedical supplies to be used during surgery in conjunction with suchmedical devices (e.g., gauze, sutures, staples, etc.). Heretofore,inventory control for many institutions comprises a simple manual countof inventory items on a periodic basis (e.g., daily, weekly, monthly,etc.). Similarly, other institutions utilize a barcode scanner to countand/or document inventory items on a periodic basis.

Aspects of the present disclosure are presented for a cloud interfaceaccessible by participating client care institutions via a cloud-basedanalytics system. In order to monitor and/or control inventory items tobe utilized or being utilized by an institution, each institution adoptsits own practice of documenting inventory item usage. For example, aninstitution may manually count and/or scan inventory items on a periodicbasis. Additional example details are disclosed in U.S. PatentApplication Publication No. 2016/0249917, titled SURGICAL APPARATUSCONFIGURED TO TRACK AN END-OF-LIFE PARAMETER, which published on Sep. 1,2016, U.S. Patent Application Publication No. 2014/0110453, titledSURGICAL INSTRUMENT WITH RAPID POST EVENT DETECTION, which issued onFeb. 23, 2016 as U.S. Pat. No. 9,265,585, U.S. Patent ApplicationPublication No. 2016/0310134, titled HANDHELD ELECTROMECHANICAL SURGICALSYSTEM, which published on Oct. 27, 2017, and U.S. Patent ApplicationPublication No. 2015/0317899, titled SYSTEM AND METHOD FOR USING RFIDTAGS TO DETERMINE STERILIZATION OF DEVICES, which published on Nov. 5,2015, the entire disclosures of which are hereby incorporated byreference herein. Information regarding counted and/or scanned inventoryitems may then be stored in a local computer system to track inventoryitem usage. Such a manual process is not only labor intensive andinefficient, but also prone to human error. As a result, an institutionmay be unable to perform a surgical procedure(s) and/or the surgicalprocedure(s) may be unnecessarily delayed because one or more inventoryitems, required for the surgical procedure(s), are not available for usefor various reasons (e.g., out of stock, in stock but expired, in stockbut no longer considered sterile, in stock but defective, etc.). Knowingthis, some institutions are forced to carry and/or hold an overstock ofinventory items. This, of course, may result in increase expense (e.g.,more inventories) and ultimately unnecessary waste (e.g., expiredinventory items).

To help institutions control inventory items, it would be desirable forinstitutions to have access, via a cloud interface, to a cloud-basedanalytics system configured to automate inventory control byautomatically receiving data associated with inventory items of theinstitutions, deriving information based on the received data, andconveying, via the cloud interface, real-time knowledge back to theinstitutions regarding inventory items. Referring to FIG. 201, accordingto one aspect of the present disclosure, a client care institutionsystem 8000 may transmit (e.g., periodically, in real-time, in batches,etc.) inventory data to a cloud-based analytics system 8002 and thecloud-based analytics system 8002 may derive/extract information fromthat inventory data. In such an aspect, a cloud-interface 8004 may beaccessed/queried by the client care institution system 8000 and thecloud-based analytics system 8002 may transmit its derived/extractedinformation to the cloud-interface 8004. Further, in such an aspect, thecloud-interface 8004 may convey/package/structure the derived/extractedinformation to the client care institution system 8000 to revealknowledge about the client care institution's inventory. In one aspect,the client care institution system may comprise a surgical system 102(e.g., FIG. 1), the cloud-based analytics system may comprise thecloud-based system 105 (e.g., FIG. 1) and the cloud-interface maycomprise at least one of a visualization system 108/208 (e.g., FIGS.1-2) or a display 135/177 associated with the surgical hub 106 (e.g.,FIGS. 1-3, 7, etc.).

Referring to FIG. 1, in some aspects of the present disclosure, acloud-based system 105 is communicatively coupled to one or more thanone surgical hub of an institution (e.g., one or more than one surgicalhub 106 of a surgical system 102). Here, each surgical hub is incommunication (e.g., wirelessly) with one or more than one inventoryitem (e.g., intelligent instrument 112). The cloud-based system 105 maybe configured to aggregate data associated with each inventory item ofeach institution, analyze that data with respect to system-definedconstraints, and generate or facilitate a cloud interface for eachinstitution to monitor and control inventory items. In one example, thecloud-based system 105 may be configured to compute a currentavailability of each inventory item (e.g., an indication of real-timeusage and/or scheduled usage for each inventory item in a surgicalsystem 102), a current usage associated with each inventory item (e.g.,based on data received from one or more than one surgical hub 106 thathas read usage data from a chip/memory associated with each inventoryitem), irregularities, if any, associated with each inventory item(e.g., defects, etc.), current possible medical device combinations thatutilize each inventory item (e.g., various shafts, staple cartridges,end effectors, etc. combinable to form numerous medical devicecombinations), and available alternatives to each inventory item (e.g.,available shaft B and/or shaft C may be substituted for unavailableshaft A for a desired/input surgical procedure(s)). Referring to FIGS.202-203, in such an exemplification, after input of a desired surgicalprocedure(s) (e.g., “cholecystectomy”) by an institution in its cloudinterface 8104, the cloud-based system 105 may provide up-to-date,real-time and/or near real-time knowledge regarding the availabilityand/or usability of inventory items (e.g., associated with and/or neededto perform the input surgical procedure(s)) based on the system-definedconstraints. Referring to FIG. 203, in one example, the institution'scloud interface 8104 may display an inventory item 8106 (e.g., HandlesA, B, and C) in association with its current 8108 and/or remaining usage8110. If the remaining usage is not adequate (e.g., based on anticipatedusage necessary for the desired surgical procedure, etc.), the cloudinterface may further display a warning or alert regarding theinadequacy (e.g., 8112, highlighting, blacked out, etc.). Such a warningor alert may indicate that the surgical procedure(s) input at the cloudinterface cannot be performed based on current inventory items. In oneaspect, a same or similar warning or alert may be communicated to theinventory item itself for display on a user interface of the inventoryitem itself (e.g., a user interface of Handle C). In another aspect, thecloud interface may further display available alternatives to theinventory item (e.g., Handle B). Here, anticipated usage and/oravailable alternatives may be determined at the surgical hub 106 (e.g.,based on local data) and/or the cloud-based analytics system 105 (e.g.,based on local data of the surgical hub 106 and/or global data frommultiple surgical hubs 106 of multiple institutions). In one example,the surgical hub 106 may infer anticipated usage and/or availablealternatives from local data associated with the same or similarsurgical procedure (e.g., average number of uses to perform the same orsimilar surgical procedure, alternative inventory items used to performthe same or similar surgical procedure, etc.). In another example, thecloud-based analytics system 105 may similarly infer anticipated usageand/or available alternatives from local data of the surgical hub 106and/or global data from multiple surgical hubs 106 of multipleinstitutions (e.g., average number of uses to perform the same orsimilar surgical procedure, alternative inventory items used to performthe same or similar surgical procedure, etc.).

In other aspects of the present disclosure, a cloud-based system 105 iscommunicatively coupled to one or more than one surgical hub 106 of aninstitution, each surgical hub 106 in communication (e.g., wirelessly)with one or more than one inventory item (e.g., intelligent instrument112). The cloud-based system 105 may be configured to create a list ofinventory items not authorized to perform surgical procedures due to oneor more system-defined constraints. In one exemplification, after inputof a desired surgical procedure(s) by an institution into its cloudinterface (e.g., FIG. 202), the cloud-based system 105 may determinethat one or more inventory items of the institution (e.g., detected byand associated with and/or needed to perform the input surgicalprocedure(s)) are not authorized to perform the input surgicalprocedure(s) based on system-defined constraints. In such anexemplification, it may be determined that an identifier (e.g., serialnumber, unique ID, etc.) associated with an inventory item is notauthorized to perform the input surgical procedure(s) (e.g., inventoryitem exceeds usable life, inventory item is counterfeit, inventory itemis defective, etc.). In one example, the institution's cloud interfacemay display an inventory item in association with its unauthorizedstatus 8114. In such an aspect, the cloud interface may further displaya warning or alert regarding the unauthorized status (e.g.,highlighting, blacked out, etc.). Such a warning or alert may indicatethat the surgical procedure(s) input at the cloud interface cannot beperformed based on current inventory items. In one aspect, a same orsimilar warning or alert may be communicated to the inventory itemitself for display on a user interface of the inventory item itself(e.g., a user interface of Handle D). Similar to above, the cloudinterface 8104 may display available alternatives to the unauthorizedinventory item (e.g., Handle B).

In yet other aspects of the present disclosure, a cloud-based system 105is communicatively coupled to one or more than one surgical hub 106 ofan institution, each surgical hub 106 in communication (e.g.,wirelessly) with one or more than one inventory item (e.g., intelligentinstrument 112). The cloud-based system 105 may be configured to createa list of inventory items no longer authorized to perform surgicalprocedures due to one or more system-defined constraints. In oneexemplification, after input of a desired surgical procedure(s) by aninstitution in its cloud interface (e.g., FIG. 202), the cloud-basedsystem may determine that one or more inventory items are no longerauthorized to perform the input surgical procedure(s) based onsystem-defined constraints. In such an exemplification, it may bedetermined that an identifier (e.g., serial number, unique ID, etc.)associated with an inventory item is unusable (e.g., expired, no longersterile, defective, etc.). In one example, the institution's cloudinterface may display an inventory item in association with its unusablestatus 8116. In such an aspect, the cloud interface may further displaya warning or alert regarding the unusable status (e.g., highlighting,blacked out, etc.). Such a warning or alert may indicate that thesurgical procedure(s) input at the cloud interface cannot be performedbased on current inventory items. In one aspect, a same or similarwarning or alert may be communicated to the inventory item itself fordisplay on a user interface of the inventory item itself (e.g., a userinterface of Handle E). Similar to above, the cloud interface maydisplay available alternatives to the unusable inventory item (e.g.,Handle B).

In this way, the cloud-based system 105 of the present disclosure mayprovide up-to-date, real-time, and/or near real-time knowledge regardingthe availability of inventory items pertinent to the surgicalprocedure(s) input to the cloud interface of the participatinginstitutions. Such a system goes well-beyond conventional processes ofmanually counting and/or scanning inventory items.

FIG. 204 illustrates an example multi-component surgical tool (e.g., awireless surgical device/instrument 235) comprising a plurality ofmodular components 8204, 8206, 8208, 8210, wherein each modularcomponent is associated with an identifier 8214, 8216, 8218, 8220respectively (e.g., a serial number). In particular, the surgical tool235 of FIG. 204 includes a handle 8204, a modular adapter 8206, and endeffector 8208 (e.g., a disposable loading unit and/or a reloadabledisposable loading unit in various aspects), and a staple cartridge8210. In this example, the handle 8204 is associated with serial number“SN135b”, the modular adapter 8206 is associated with serial number“SN33b”, the end effector 8208 is associated with serial number “SN1a”and the staple cartridge 8210 is associated with serial number SN121b.In such an aspect, each modular component (e.g., 8204, 8206, 8208, 8210,etc.) is configured to request a communication link to a surgical hub106 of an institution. In other aspects, the surgical hub 106 may beconfigured to request a communication link with each modular component.Nonetheless, the surgical hub 106 is positioned within a communicativedistance from each modular component (e.g., in an operating room). Inone aspect of the present disclosure, a requested communication link isestablished via BLUETOOTH pairing. In other aspects of the presentdisclosure, other forms of wireless communication (e.g., WiFi, RFID,etc.) or wired communication are contemplated. Referring again to FIG.204, each modular component (e.g., handle 8204, modular adapter 8206,end effector 8208, staple cartridge 8210, etc.) may comprise a processorand a memory unit (not shown) that stores its respective serial number.Here, according to one aspect, once a communication link is establishedbetween the surgical hub 106 and each modular component, the identifier(e.g., serial number) associated with each modular component istransmitted by each modular component to the surgical hub 106 (e.g., viathe same form or different forms of wired/wireless communication). Inone alternative aspect, in light of FIG. 204, a modular component (e.g.,modular adapter 8206, end effector 8208, and/or staple cartridge 8210,etc.) may transmit its respective identifier (e.g., serial number) toanother modular component (e.g., handle 8204) that transmits/relays allidentifier(s) to the surgical hub 106. Here, similar to above, the sameform or different forms of wired/wireless communication may be used. Forexample, each of the modular adapter 8206, the end effector 8208 and thestaple cartridge 8210 may transmit its respective identifier (e.g.,8216, 8218, 8220) to the handle 8204 via RFID and the handle 8204 mayrelay such identifiers (e.g., 8216, 8218, 8220) along with its ownidentifier 8214, via BLUETOOTH, to the surgical hub 106. In one aspect,once the surgical hub 106 has received all identifiers for all modularcomponents, the surgical hub 106 may transmit the identifiers to thecloud-based analytics system (e.g., comprising cloud-based system 105).

In various aspects of the present disclosure, the memory unit of eachmodular component may be configured to store more than its identifier.In one aspect of the present disclosure, each modular component (e.g.,8204, 8206, 8208, 8210, etc.) may further comprise a counter (not shown)configured to track a usage parameter of the modular component and itsmemory unit may be configured to store that usage parameter. In anotheraspect, the memory unit of each respective modular component may befurther configured to store a usable life metric. Such a usable lifemetric may be stored during manufacture of the modular component. Forexample, in view of FIG. 204, the memory unit of the handle 8204 maystore both the usage parameter (e.g., 235) and the usable life metric(e.g., 400). In such an aspect, the handle 8204 has been used 235 timesout of its usable life of 400 uses. Similarly, in view of FIG. 204, themodular adapter has been used 103 times out of its usable life of 100uses, and the end effector has been used 5 times out of its usable lifeof 12 uses. Here, similar to above, once a communication link isestablished with the surgical hub 106, the identifier, usage parameterand/or usable life metric stored in the memory unit of each modularcomponent may be transmitted directly from each modular component to thesurgical hub 106 or indirectly via another modular component. Inaddition, similar to above, the same form or different forms ofwired/wireless communication may be used. In one aspect, once thesurgical hub 106 has received all identifiers for all modularcomponents, the surgical hub 106 may transmit the identifiers to thecloud-based analytics system (e.g., comprising cloud-based system 105).

In an alternative aspect of the present disclosure, the memory unit ofeach modular component may not store its usage parameter and/or theusable life metric. In such an aspect, the usage parameter and/or theusable life metric may be stored in a database or other memory (see FIG.10, e.g., 248/249) at the surgical hub 106/206. In such an aspect, thesurgical hub 106 may comprise a counter configured to track a usageparameter of each modular component in inventory. Furthermore, thesurgical hub 106 may be configured to download usable life metrics(e.g., from a manufacturer server) based on the identifier (e.g., serialnumber) received from each modular component. In various aspects,storage at the surgical hub 106 may be preferred to minimize memory unitrequirements in each modular component and/or to avoid any concernsregarding the tampering with and/or the alteration of usage parametersand/or usable life metrics stored at the modular component level (e.g.,altering a memory unit of a modular component to reset a usage parameterand/or increase a usable life metric, etc.).

In one example, in aspects where the memory unit of each modularcomponent stores its usage parameter and/or usable life metric, thesurgical hub 106 may also store/track the usage parameter and/or usablelife metric associated with each modular component in its inventory. Insuch an example, if a usage parameter and/or a usable life metrictransmitted from a modular component differs from a usage parameterand/or a usable life metric stored/tracked at the surgical hub 106, thesurgical hub 106 may flag the discrepancy and modify the status of thatmodular component (e.g., to unavailable, to unauthorized, to unusable,etc.).

In another alternative aspect, the memory unit of each modular componentmay not store its usage parameter and/or the usable life metric. In suchan aspect, the usage parameter and/or the usable life metric may bestored in a database (e.g., aggregated medical data database 7012 inFIG. 180) at a cloud-based analytics system. In such an aspect, thecloud-based analytics system may comprise a counter configured to tracka usage parameter of each modular component in inventory at eachsurgical hub. Furthermore, the cloud-based analytics system may beconfigured to download usable life metrics (e.g., from a manufacturerserver) based on the identifier (e.g., a serial number) received fromeach modular component (e.g., via a surgical hub). Alternatively, thecloud-based analytics system may download a file comprising allidentifiers for all modular components (e.g., from a plurality ofmanufacturers) wherein each identifier is associated with a usable lifemetric. Here, the cloud-based analytics system may be configured tolook-up a received identifier to determine each respective usable lifemetric. In various aspects, storage at the cloud-based analytics systemmay be preferred to minimize memory requirements in each modularcomponent and/or to avoid any concerns regarding the tampering withand/or the alteration of usage parameters and/or usable life metrics atthe modular component level and/or at the surgical hub level (e.g.,altering memory unit of a modular component to reset a usage parameterand/or increase a usable life metric, modifying the database/memory ofthe surgical hub to reset a usage parameter and/or increase a usablelife metric). Such as aspect gives the cloud-based analytics system ofthe present disclosure more control over modular component use in theinteractive surgical system.

Looking again to FIG. 204, the illustrated multi-component surgical tool235 comprises four modular components (e.g., handle 8204, modularadapter 8206, end effector 8208, and staple cartridge 8210). Suchmodular devices may comprise reusable and/or reprocessed components. Invarious aspects, each modular component must satisfy system-definedconstraints for the combined multi-component surgical tool 235 to beavailable/usable/authorized for use by the cloud-based analytics system.Notably, system-defined constraints may include restrictions other thanand/or in addition to the usable life metric discussed above. Suchsystem-defined constraints may be established at the manufacturer level,at the surgical hub level, and/or at the cloud-based analytics systemlevel. One aspect of the present disclosure comprises a user interfaceat the surgical hub and/or cloud-based analytics system to createsystem-defined constraints.

In one aspect, the surgical hub 106 may be configured to enforcesystem-defined constraints (e.g., lockout at the hub level). In such anaspect, this may be preferred so that the surgical hub 106 is a localgateway to accessing the cloud-based analytics system. In anotheraspect, the cloud-based analytics system (e.g., comprising cloud-basedsystem 105) may be configured to enforce system-defined constraints(e.g., lockout at the cloud-based analytics system level). In such anaspect, this may be preferred to maintain control over all surgical hubscommunicatively coupled to the cloud-based analytics system (e.g., atone institution or at multiple institutions). System-definedconstraints, similar to the usable life metric, may be associated withthe identifier of each modular component. For example, a system-definedconstraint associated with a modular component may include an expirationdate, a requirement that an identifier (e.g., serial number) is asystem-recognizable identifier (e.g., not counterfeit), and/or flexiblesystem-defined constraints (e.g., constraints deemed non-critical untila threshold is met and the constraint is deemed critical). In one aspectof the present disclosure, if one system-defined constraint is not met,a modular component (e.g., 8204, 8206, 8208, 8210, etc.) may be deemedunavailable/unusable/unauthorized despite beingavailable/usable/authorized based on other system-defined constraint(s)(e.g., having remaining usable life). In various aspects, one or morepredetermined system-defined constraints are non-critical system-definedconstraints. Such non-critical system-defined constraints may be waived(see FIG. 204, e.g., 8274, manual override) to render the modularcomponent available/usable/authorized and/or may produce in a warningindicator/message (see FIG. 204, e.g., 8244). Critical system-definedconstraints cannot be waived.

In view of FIG. 204, an example non-critical system-defined constraintis applied (e.g., by the surgical hub 106 and/or the cloud-basedanalytics system) to the handle 8204. Here, although the handle 8204 has165 remaining uses (usable life metric less determined usage parameter,e.g., 400-235) an expiration date associated with its identifier 8214(e.g., SN135b) indicates that the handle's control program isout-of-date. In such an aspect, an interface 8200 may be displayed toshow a current status of the handle 8204 (see FIG. 204, e.g., “Count235/400” and/or “Out-of-Date”). More specifically, the interface 8200may comprise a grid including fields defined by columns and rows. In oneexample, the modular components of a proposed multi-component surgicaltool 235 may be presented (e.g., in an exploded, unassembled view)across the columns of the grid in a first row 8201 and a current/updatedstatus associated with each modular component may be presented acrosscorresponding columns of the grid in a second row 8202. As such, inaccordance with the example, status field 8224 of the interface 8200corresponds to the handle 8204 and indicates its current status as“COUNT: 235/400” and “OUT-OF-DATE”. According to other aspects, thestatus field 8224 of the interface 8200 may further show the usageremaining, remaining capabilities, and/or compatibility with otherconnected modular components, etc.

According to one aspect, the interface 8200 may comprise a cloud-basedinterface (see FIG. 203, e.g., 8104) accessible on a cloud-accessterminal of the surgical hub (via at least one of a visualization system108/208 (e.g., FIGS. 1-2) or a display 135/177 associated with thesurgical hub 106 (e.g., FIGS. 1-3, 7, etc.)). According to anotheraspect, the interface 8200 may comprise only a portion(s) of the grid(e.g., status field 8224, modular component field 8234, etc.) accessibleon the physical handle 8204 itself via a user interface positioned onthe handle 8204. Further, in the context of a non-criticalsystem-defined constraint, the interface 8200 may visually indicate awarning associated with a modular component (e.g., warning indicator8244, e.g., box associated with identifier 8214 highlighted and/orencircled and/or comprises a link 8254 (e.g., “A”) in association withmodular component field 8234 of the interface 8200). In one aspect, thelink 8254 (e.g., “A”) may key to a corresponding “Description ofProblem” section of the interface 8200 (e.g., “A” “Handle Serial NumberIndicates OUT OF DATE Control Program”). In another aspect, the link8254 (e.g., “A”) may be a hyperlink to present the correspondingdescription (e.g., “A” “Handle Serial Number Indicates OUT OF DATEControl Program”) in the interface 8200. According to such aspects, aportion of the descriptive text (e.g., “OUT OF DATE”), keyed/hyperlinkedvia link 8254, may be a hyperlink/button 8264. Upon/After selection ofthe hyperlink/button 8264 a bypass interface 8274 may be presented inthe interface 8200. According to another aspect, a portion ofdescriptive text (e.g., OUT-OF-DATE) in status field 8224 may be ahyperlink/button 8284 to, upon/after selection, directly present thebypass interface 8274 in the interface 8200. Such an aspect may bebeneficial/more efficient if the interface 8200 is being presented via a(e.g., smaller) user interface of a modular component (e.g., handle8204). Further, according to such aspects, the interface 8200 may beconfigured to receive user input to waive (e.g., manually bypass) apredetermined, non-critical system-defined constraint (e.g., theexpiration date constraint). In the context of a non-criticalsystem-defined constraint, the bypass interface 8274 may instruct “USERINPUT NEEDED” and present a first user-interface element (e.g., “Y”button) selectable to bypass the non-critical system-defined constraint(e.g., to permit use of the handle 8204) and a second user-interfaceelement (e.g., “N” button) selectable to not bypass the non-criticalsystem-defined constraint (e.g., to inhibit use of the handle 8204).Here, a selection in the bypass interface 8274 may be transmitted toupdate the surgical hub 206 and/or the cloud-based system 205.

Next, in view of FIG. 204, an example flexible system-defined constraintis applied (e.g., by the surgical hub 106 and/or the cloud-basedanalytics system) to the modular adapter 8206. Here, the modular adapter8206 associated with identifier 8216 (e.g., SN33b) has a usage parameterof 103 (e.g., already 3 times over its suggested usable life metric of100 uses). In this example, the exceeding use is deemed non-criticaluntil a 10% overage threshold is met (e.g., 110% of the suggested 100uses, or 110 uses) and the exceeding use is deemed critical. In such anaspect an interface 8200 may be displayed to show a current status ofthe modular adapter 8206 (see FIG. 204, e.g., “COUNT: 103/100”“EXCEEDS”). More specifically, in accordance with the example describedabove, status field 8226 corresponds to the modular adapter 8206 andindicates its current status as “COUNT: 103/100” and “EXCEEDS”.According to other aspects the status field 8226 of the interface 8200may further show overage remaining, remaining capabilities, and/orcompatibility with other connected modular components.

Again, according to one aspect the interface 8200 may comprise acloud-based interface (see FIG. 203, e.g., 8104) accessible on acloud-access terminal of the surgical hub (via at least one of avisualization system 108/208 (e.g., FIGS. 1-2) or a display 135/177associated with the surgical hub 106 (e.g., FIGS. 1-3, 7, etc.)).According to another aspect, the interface 8200 may comprise only aportion(s) of the grid (e.g., the status field 8226, modular componentfield 8236, etc.) accessible directly on the physical modular adapter8206 itself via a user interface positioned on the modular adapter 8206and/or indirectly on the physical handle 8204 itself via a userinterface positioned on the handle 8204. Further, in the context of aflexible system-defined constraint, the interface 8200 may visuallyindicate a warning associated with a modular component (e.g., warningindicator 8246, e.g., description of current status encircled and/orcomprises a link 8256 (e.g., “B”) in association with status field 8226of the interface 8200). In one aspect, the link 8256 (e.g., “B”) may keyto a corresponding “Description of Problem” section of the interface8200 (e.g., “B” “Modular Adapter EXCEEDS Suggested Life Limit”). Inanother aspect, the link 8256 (e.g., “B”) may be a hyperlink to presentthe corresponding description (e.g., “B” “Modular Adapter EXCEEDSSuggested Life Limit”) in the interface 8200. According to such aspects,a portion of the descriptive text (e.g., “EXCEEDS”), keyed/hyperlinkedvia link 8256, may be a hyperlink/button 8266. Upon/After selection ofthe hyperlink/button 8266 a warning interface 8276 may be presented inthe interface 8200. According to another aspect, a portion ofdescriptive text (e.g., EXCEEDS) in status field 8226 may be ahyperlink/button 8286 to, upon/after selection, directly present thewarning interface 8276 in the interface 8200. Such an aspect may bebeneficial/more efficient if the interface 8200 is being presented via a(e.g., smaller) user interface of a modular component (e.g., modularadapter 8206 and/or handle 8204). Further, according to such aspects,the interface 8200 may be configured to present a warning that themodular adapter 8206 is approaching its overage threshold. In oneaspect, the warning interface 8276 may instruct “NO INPUT NEEDED” andpresent a warning indicating that the overage threshold is beingapproached (e.g., “Approaching 10% Limit Warning”). In other aspects,the warning may indicate how many uses remain until the overagethreshold is met (e.g., “7 Uses Until 10% Overage Limit Is Met”).

Next, in view of FIG. 204, an example system-defined constraint isapplied (e.g., by the surgical hub 106 and/or the cloud-based analyticssystem) to the end effector 8208. Here, the end effector 8208 associatedwith identifier 8218 (e.g., SN1a) has a usage parameter of 5 (e.g., 7uses under its suggested usable life metric of 12 uses remain). As such,in accordance with this example, the system-defined constraint is deemedsatisfied and the end effector 8208 is renderedavailable/usable/authorized. In such an aspect, an interface 8200 may bedisplayed to show a current status of the end effector 8208 (see FIG.204, e.g., “COUNT: 5/12”). More specifically, in accordance with theexample described above, status field 8228 corresponds to the modularadapter 8208 and indicates its current status as “COUNT: 5/12”.According to other aspects the status field 8228 of the interface 8200may further show usage remaining, remaining capabilities, and/orcompatibility with other connected modular components.

Yet again, according to one aspect, the interface 8200 may comprise acloud-based interface (see FIG. 203, e.g., 8104) accessible on acloud-access terminal of the surgical hub (via at least one of avisualization system 108/208 (e.g., FIGS. 1-2) or a display 135/177associated with the surgical hub 106 (e.g., FIGS. 1-3, 7, etc.)).According to another aspect, the interface 8200 may comprise only aportion(s) of the grid (e.g., the status field 8228, modular componentfield 8238, etc.) accessible directly on the physical end effector 8208itself via a user interface positioned on the end effector 8208 and/orindirectly on the physical handle 8204 itself via a user interfacepositioned on the handle 8204. Here, since the system-defined constraintis satisfied, no warning interface and/or bypass interface is displayed.

Lastly, still in view of FIG. 204, an example critical system-definedconstraint is applied (e.g., by the surgical hub 106 and/or thecloud-based analytics system) to the staple cartridge 8210. Here,identifier 8220 (e.g., SN121b), associated with the staple cartridge8210, is not a system-recognizable identifier. According to one aspect,this may occur when the surgical hub 206 and/or the cloud-basedanalytics system (e.g., comprising cloud-based system 205) is unable tomatch an identifier (e.g., serial number) received from a modularcomponent with identifiers (e.g., serial numbers) downloaded from themanufacturer(s) of the modular component(s). As such, continuing theexample, the system-defined constraint is critical, the system-definedconstraint is deemed not satisfied, and the staple cartridge 8210 isrendered unavailable/unusable/unauthorized. Further, as a result, sincethe critical system-defined constraint cannot be waived, any combinedmulti-component surgical tool comprising the staple cartridge 8210 maybe similarly rendered unavailable/unusable/unauthorized. In such asaspect, an interface 8200 may be displayed to show a current status ofthe staple cartridge 8210 (see FIG. 204, e.g., “LOADED” “COUNTERFEIT”).More specifically, in accordance with the example described above,status field 8230 corresponds to the staple cartridge 8210 and indicatesits current status as “LOADED” and “COUNTERFEIT”.

Yet again, according to one aspect, the interface 8200 may comprise acloud-based interface (see FIG. 203, e.g., 8104) accessible on acloud-access terminal of the surgical hub (via at least one of avisualization system 108/208 (e.g., FIGS. 1-2) or a display 135/177associated with the surgical hub 106 (e.g., FIGS. 1-3, 7, etc.)).According to another aspect, the interface 8200 may comprise only aportion(s) of the grid (e.g., the status field 8230, modular componentfield 8240, etc.) accessible directly on the physical staple cartridge8210 itself via a user interface positioned on the staple cartridge 8210and/or indirectly on the physical handle 8204 itself via a userinterface positioned on the handle 8204. Further, in the context of acritical system-defined constraint, the interface 8200 may visuallyindicate a warning associated with a modular component (e.g., warningindicator 8250, e.g., box associated with identifier 8220 highlightedand/or encircled and/or comprises a link 8260 (e.g., “C”) in associationwith modular component field 8240 of the interface 8200). In one aspect,the link 8260 (e.g., “C”) may key to a corresponding “Description ofProblem” section of the interface 8200 (e.g., “C” “Serial Number ofCartridge Indicates COUNTERFEIT Cartridge”). In another aspect, the link8260 (e.g., “C”) may be a hyperlink to present the correspondingdescription (e.g., “C” “Serial Number of Cartridge Indicates COUNTERFEITCartridge”) in the interface 8200. According to such aspects, a portionof the descriptive text (e.g., “COUNTERFEIT”), keyed/hyperlinked vialink 8260, may be a hyperlink/button 8270. Upon/After selection of thehyperlink/button 8270 an action interface 8280 may be presented in theinterface 8200. According to another aspect, a portion of descriptivetext (e.g., COUNTERFEIT) in status field 8230 may be a hyperlink/button8290 to, upon/after selection, directly present the action interface8280 in the interface 8200. Such an aspect may be beneficial/moreefficient if the interface 8200 is being presented via a (e.g., smaller)user interface of a modular component (e.g., staple cartridge 8210and/or handle 8204). Further, according to such aspects, the interface8200 may be configured to instruct a user to perform an action (e.g., toremove the staple cartridge 8210 associated with the identifier 8220(e.g., SN121b) and reload with a staple cartridge associated with asystem-recognizable identifier. In one aspect, the action interface 8280may instruct “ACTION REQUIRED” and present a directive “Remove &Reload”. Here, since the system-defined constraint is critical, nowarning interface and/or bypass interface is displayed. In one furtheraspect, a list of available and/or alternative modular components (e.g.,staple cartridges) may be displayed.

In a similar manner, a list (e.g., black-listed devices) of surgicaltools (e.g., wireless surgical devices/instruments 235) and/or modularcomponents (e.g., handles, modular adapters, end effectors, staplecartridges, etc.) may be declared unavailable/unusable/unauthorized tocommunicate with and/or access the surgical hub 206 and/or cloud-basedanalytics system (e.g., comprising cloud-based system 205). In oneaspect of the present disclosure, such black-listed devices may compriseinventory items that are known and/or established to be counterfeit,defective, damaged, beyond their usable life, expired, unsterile, etc.In such an aspect, black-listed devices may be used as criticalsystem-defined constraints (e.g., if the device is on the “black-list,”it cannot communicate with and/or access the surgical hub and/orcloud-based analytics system). In line with above, criticalsystem-defined constraints cannot be waived/bypassed. Creating and/ormaintaining such a “black-list” of devices at the surgical hub leveland/or the cloud-based analytics level, may improve safety andreliability in the operating room. In one aspect, a database (e.g.,aggregated medical data database 7012 in FIG. 180) at the cloud-basedanalytics system may be updated each time a counterfeit device isdetected via a surgical hub 206 (e.g., similar to the staple cartridgein FIG. 204). Since a plurality of surgical hubs associated with aplurality institutions may communicate with the cloud-based analyticssystem, such a database, and associated “black-list”, builds ratherquickly. Such a database at the cloud-based analytics system wouldprevent a black-listed device from being used at a different surgicalhub (e.g., a surgical hub other than the surgical hub at which thecounterfeit was initially detected) communicatively coupled to thecloud-based analytics system.

In another aspect of the present disclosure, black-listed devices mayinclude surgical tools (e.g., wireless surgical devices/instruments 235)and/or modular components (e.g., handles, modular adapters, endeffectors, staple cartridges, etc.) developed by third-parties wishingto take advantage of benefits provided by the surgical hub and/orcloud-based analytics system (e.g., various inventory control aspectsdiscussed herein). In such an aspect of the present disclosure,black-listed devices may be used as non-critical system-definedconstraints and/or flexible system-defined constraints (e.g., if thedevice is on the “black-list,” it cannot communicate with and/or accessthe surgical hub and/or cloud-based analytics system). However, contraryto the previously disclosed aspect, such non-critical system-definedconstraints and/or flexible system-defined constraints may bewaived/bypassed. In one aspect of the present disclosure, such ablack-listed device (e.g., a third-party device) may be granted accessto the surgical hub and/or cloud-based analytics system for a fee. Inone example a competitor product may be initially declared counterfeit.However, once an agreed upon fee is paid, that competitor product may begranted access to the surgical hub and/or cloud-based analytics system.In another aspect, such a black-listed device may be granted partialaccess to the surgical hub and/or cloud-based analytics system but maybe subject to established secondary system-defined constraints. Inanother aspect, such a black-listed device may be granted access to thesurgical hub and/or cloud-based analytics system but may not be able tofully function (e.g., limited functionality) when paired with thesurgical hub. Similar to above, a database (e.g., aggregated medicaldata database 7012 in FIG. 180) at the cloud-based analytics system maybe updated each time a previously black-listed device is granted access,partial access with secondary system-defined constraints and/or accesswith limited functionality. Since a plurality of surgical hubsassociated with a plurality institutions may communicate with thecloud-based analytics system, such a database, and its associated accesslevels, can be implemented across all communicatively coupled surgicalhubs. In all such aspects, the surgical hub and/or cloud-based analyticssystem maintains complete control over devices seeking access.

In yet another aspect of the present disclosure a database of thesurgical hub (see FIG. 10, e.g., 248/249) and/or a database (e.g.,aggregated medical data database 7012 in FIG. 180) of the cloud-basedanalytics system may record each modular component and/or surgical toolidentifier (e.g., serial number) in a “used identifier list” when firstused in the system. As such, each time a new modular component and/or anew surgical tool is plugged in and/or requests communication with thesurgical hub and/or cloud-based analytics system, an identifier of thenew modular component and/or surgical tool is cross-checked with the“used identifier list.” In such an aspect, if the identifier of the newmodular component and/or the new surgical tool matches an identifieralready in the “used identifier list,” that identifier may beautomatically placed on a “black-list” (e.g., critical system-definedconstraint). Here, identifiers (e.g., serial numbers) should be unique.If an already used identifier is presented at first use multiple times,this may evidence fraud and/or counterfeit activity.

As discussed herein, various aspects of the present disclosure aredirected to the application of system-defined constraints. For example,as discussed with reference to FIG. 204 above, each modular component ofa surgical tool may be associated with an identifier and each identifiermay be associated with one or more than one parameter (e.g., usageparameter, expiration date, flexible parameter, etc.). In another aspectof the present disclosure, a surgical tool may be associated with anidentifier wherein that identifier is associated with one or more thanone parameter. In such an aspect, either the surgical tool does notcomprise modular components or the surgical tool comprises modularcomponents associated with the same identifier (e.g., serial number,activation code). Here, system-defined constraints, as discussed herein,may be applied to such a surgical tool in a similar manner.

Further, as discussed herein, various aspects of the present disclosurepertain to the identification of reusable/reprocessed devices (e.g.,modular components, surgical tools, etc.) and the display of eachreusable device's availability/readiness for a next/proposed surgicalprocedure and its operational status on a screen other than the screenof the reusable device (e.g., a screen of a cloud-access terminal of thesurgical hub). In one aspect of the present disclosure the status ofeach reusable device (e.g., status of each modular component, status ofa surgical tool, and/or overall status of combined modular componentsand/or subassemblies) is queried and/or determined when the reusabledevice connects to the system or as the reusable device connects to thesystem (e.g., to the surgical hub and/or the cloud-based analyticssystem). In another aspect of the present disclosure, once/after thereusable device is used, the surgical hub and/or cloud-based analyticssystem time-stamps the use and updates the usage of each modularcomponent and/or surgical tool in its respective database.

In further various aspects of the present disclosure, a modularcomponent and/or a surgical tool may be flagged by the surgical huband/or cloud based analytics system based on predetermined criteria. Forexample, if a modular component is incompatible with other modularcomponents, its identifier (e.g., serial number) is known to be fake,and/or it is subject to a recall, a database of the surgical hub and/orthe cloud-based analytics system may be updated to not allow use of themodular component and/or surgical tool in the system (e.g., creation ofcritical system-defined constraints). Such created system-definedconstraints may be applied as discussed herein.

In yet further aspects of the present disclosure, a modular componentand/or a surgical tool may be flagged by the surgical hub and/or cloudbased analytics system based on a previous use. For example, thesurgical hub and/or the cloud based analytics system may trackperformance of the modular component and/or the surgical tool. Here,performance results may be analyzed by the cloud-based analytics systemto inform future uses of the modular component and/or surgical tool. Forexample, if the end effector did not clamp properly or jammed in aprevious use, the end effector may be flagged in a database of thesurgical hub and/or the cloud-based analytics system (e.g.,black-listed) so that the end effector cannot be used again in thesystem.

Various aspects of the present disclosure are also directed to acloud-based analytics system that generates a cloud interface for aclient care institution. More specifically, aspects of the presentdisclosure pertain to a cloud-based system including a client careinstitution surgical hub coupleable with a plurality of inventory items(e.g., handles, modular adapters, end effectors, staple cartridges,etc.) and a cloud-based analytics system. The surgical hub may include aprocessor programmed to communicate with the plurality of inventoryitems and the cloud-based analytics system. The cloud-based analyticssystem may include a processor programmed to i) receive, via thesurgical hub, data associated with the plurality of inventory items,wherein the received data comprises a unique identifier for eachinventory item, ii) determine whether each inventory item is availablefor use based on its respective unique identifier and system-definedconstraints, wherein the system-defined constraints comprise at leastone use restriction, iii) generate a cloud interface for theinstitution, wherein the institution's cloud interface comprises aplurality of user-interface elements, wherein at least oneuser-interface element enables the institution to select one or morethan one surgical procedure to be performed, and wherein after selectionof a surgical procedure, via the at least one user-interface element,the availability of each inventory item associated with the selectedsurgical procedure is dynamically generated on the institution's cloudinterface, and iv) display an alert for each inventory item determinedas not available based on the system-defined constraints, wherein thealert is displayable on at least one of the institution's cloudinterface or the inventory item. Here, in line with the disclosureherein, alternative inventory items for unavailable items may also bedisplayed. Such a cloud interface enables an institution to evaluatewhether a desired/proposed surgical procedure can proceed based oncurrent inventories. Here, data at the surgical hub level (e.g.,historical local usage) and/or the cloud-based analytics system level(e.g., historical local and/or global usage) may be used to determinecombinations of modular components and/or surgical tools usable for thesurgical procedure selected via the user-interface element. Furthermore,alternative and/or preferred modular components and/or surgical toolsmay be recommended for the surgical procedure selected via theuser-interface element. Such a recommendation (e.g., best practices) maybe based on a statistical analysis of data at the surgical hub leveland/or the cloud-based analytics system level. Such a recommendation mayor may not be based on current inventory of the institution.

In yet another aspect of the present disclosure, a modular componentand/or surgical tool may be a single-use device rather than a reusableand/or reprocessed device. In such an aspect, packaging associated withthe single-use device may include a one-time use activation code. Insuch an aspect, the one-time use activation code may be entered into anactivation input field on a cloud interface via the cloud-accessterminal of the surgical hub and transmitted to the cloud-basedanalytics system. Here, upon receipt, the cloud-based analytics systemmay cross-check the one-time use activation code with a database ofone-time use activation codes (e.g., downloaded from a manufacturer) toauthorize use with the system. If the one-time use activation codematches an unused activation code, the modular component and/or surgicaltool is authorized. However, if the one-time use activation code doesnot match an activation code in the database or the one-time useactivation code matches an already used activation code, that one-timeuse activation code may be placed on a black-list such that thesingle-use modular component and/or surgical tool is not authorized(e.g., critical system-defined constraint).

Robotic Systems

Aspects of the present disclosure also include detailed description ofvarious robotic surgical devices and systems that are configured tointerface with a Hub system, which may ultimately be interconnected tothe cloud-based medical analytics system. The combination of multipleHub systems, each communicatively coupled to a robotic surgical system,with the Hub systems communicatively coupled to the cloud-based medicalanalytics system, forms a comprehensive digital medical system that iscapable of servicing a great number of patients while providing improvedcare and insights through the aggregation and analysis of data providedby each of the multiple Hub systems and respectively coupled roboticsurgical systems. Described below are examples of structures andfunctions of various robotic surgical devices and systems configured tointegrate with this comprehensive digital medical system.

Robotic surgical systems can be used in minimally invasive medicalprocedures. During such medical procedures, a patient can be placed on aplatform adjacent to a robotic surgical system, and a surgeon can bepositioned at a console that is remote from the platform and/or from therobot. For example, the surgeon can be positioned outside the sterilefield that surrounds the surgical site. The surgeon provides input to auser interface via an input device at the console to manipulate asurgical tool coupled to an arm of the robotic system. The input devicecan be a mechanical input devices such as control handles or joysticks,for example, or contactless input devices such as optical gesturesensors, for example.

The robotic surgical system can include a robot tower supporting one ormore robotic arms. At least one surgical tool (e.g. an end effectorand/or endoscope) can be mounted to the robotic arm. The surgicaltool(s) can be configured to articulate relative to the respectiverobotic arm via an articulating wrist assembly and/or to translaterelative to the robotic arm via a linear slide mechanism, for example.During the surgical procedure, the surgical tool can be inserted into asmall incision in a patient via a cannula or trocar, for example, orinto a natural orifice of the patient to position the distal end of thesurgical tool at the surgical site within the body of the patient.Additionally or alternatively, the robotic surgical system can beemployed in an open surgical procedure in certain instances.

A schematic of a robotic surgical system 15000 is depicted in FIG. 205.The robotic surgical system 15000 includes a central control unit 15002,a surgeon's console 15012, a robot 15022 including one or more roboticarms 15024, and a primary display 15040 operably coupled to the controlunit 15002. The surgeon's console 15012 includes a display 15014 and atleast one manual input device 15016 (e.g., switches, buttons, touchscreens, joysticks, gimbals, etc.) that allow the surgeon totelemanipulate the robotic arms 15024 of the robot 15022. The readerwill appreciate that additional and alternative input devices can beemployed.

The central control unit 15002 includes a processor 15004 operablycoupled to a memory 15006. The processor 15004 includes a plurality ofinputs and outputs for interfacing with the components of the roboticsurgical system 15000. The processor 15004 can be configured to receiveinput signals and/or generate output signals to control one or more ofthe various components (e.g., one or more motors, sensors, and/ordisplays) of the robotic surgical system 15000. The output signals caninclude, and/or can be based upon, algorithmic instructions which may bepre-programmed and/or input by the surgeon or another clinician. Theprocessor 15004 can be configured to accept a plurality of inputs from auser, such as the surgeon at the console 15012, and/or may interfacewith a remote system. The memory 15006 can be directly and/or indirectlycoupled to the processor 15004 to store instructions and/or databases.

The robot 15022 includes one or more robotic arms 15024. Each roboticarm 15024 includes one or more motors 15026 and each motor 15026 iscoupled to one or more motor drivers 15028. For example, the motors15026, which can be assigned to different drivers and/or mechanisms, canbe housed in a carriage assembly or housing. In certain instances, atransmission intermediate a motor 15026 and one or more drivers 15028can permit coupling and decoupling of the motor 15026 to one or moredrivers 15028. The drivers 15028 can be configured to implement one ormore surgical functions. For example, one or more drivers 15028 can betasked with moving a robotic arm 15024 by rotating the robotic arm 15024and/or a linkage and/or joint thereof. Additionally, one or more drivers15028 can be coupled to a surgical tool 15030 and can implementarticulating, rotating, clamping, sealing, stapling, energizing, firing,cutting, and/or opening, for example. In certain instances, the surgicaltools 15030 can be interchangeable and/or replaceable. Examples ofrobotic surgical systems and surgical tools are further describedherein.

The reader will readily appreciate that the computer-implementedinteractive surgical system 100 (FIG. 1) and the computer-implementedinteractive surgical system 200 (FIG. 9) can incorporate the roboticsurgical system 15000. Additionally or alternatively, the roboticsurgical system 15000 can include various features and/or components ofthe computer-implemented interactive surgical systems 100 and 200.

In one exemplification, the robotic surgical system 15000 can encompassthe robotic system 110 (FIG. 2), which includes the surgeon's console118, the surgical robot 120, and the robotic hub 122. Additionally oralternatively, the robotic surgical system 15000 can communicate withanother hub, such as the surgical hub 106, for example. In one instance,the robotic surgical system 15000 can be incorporated into a surgicalsystem, such as the computer-implemented interactive surgical system 100(FIG. 1) or the computer-implemented interactive surgical system 200(FIG. 9), for example. In such instances, the robotic surgical system15000 may interact with the cloud 104 or the cloud 204, respectively,and the surgical hub 106 or the surgical hub 206, respectively. Incertain instances, a robotic hub or a surgical hub can include thecentral control unit 15002 and/or the central control unit 15002 cancommunicate with a cloud. In other instances, a surgical hub can embodya discrete unit that is separate from the central control unit 15002 andwhich can communicate with the central control unit 15002.

Another surgical robotic system is the da Vinci® surgical robotic systemby Intuitive Surgical, Inc. of Sunnyvale, Calif. An example of a systemis depicted in FIGS. 206-212. FIG. 206 depicts a minimally invasiverobotic surgical (MIRS) system 12010 typically used for performing aminimally invasive diagnostic or surgical procedure on a patient 12012who is lying down on an operating table 12014. The system 12010 includesa surgeon's console 12016 for use by a surgeon 12018 during theprocedure. One or more assistants 12020 may also participate in theprocedure. The MIRS system 12010 can further include a patient side cart12022, i.e. a surgical robot, and an electronics cart 12024. Thesurgical robot 12022 can manipulate at least one removably coupled toolassembly 12026 (hereinafter referred to as a “tool”) through a minimallyinvasive incision in the body of the patient 12012 while the surgeon12018 views the surgical site through the console 12016. An image of thesurgical site can be obtained by an imaging device such as astereoscopic endoscope 12028, which can be manipulated by the surgicalrobot 12022 to orient the endoscope 12028. Various alternative imagingdevices are further described herein.

The electronics cart 12024 can be used to process the images of thesurgical site for subsequent display to the surgeon 12018 through thesurgeon's console 12016. The number of robotic tools 12026 used at onetime will generally depend on the diagnostic or surgical procedure andthe space constraints within the operating room among other factors. Ifit is necessary to change one or more of the robotic tools 12026 beingused during a procedure, an assistant 12020 may remove the robotic tool12026 from the surgical robot 12022, and replace it with another tool12026 from a tray 12030 in the operating room.

Referring primarily to FIG. 207, the surgeon's console 12016 includes aleft eye display 12032 and a right eye display 12034 for presenting thesurgeon 12018 with a coordinated stereo view of the surgical site thatenables depth perception. The console 12016 further includes one or moreinput control devices 12036, which in turn cause the surgical robot12022 (FIG. 206) to manipulate one or more tools 12026 (FIG. 206). Theinput control devices 12036 can provide the same degrees of freedom astheir associated tools 12026 (FIG. 206) to provide the surgeon withtelepresence, or the perception that the input control devices 12036 areintegral with the robotic tools 12026 so that the surgeon has a strongsense of directly controlling the robotic tools 12026. To this end,position, force, and tactile feedback sensors may be employed totransmit position, force, and tactile sensations from the robotic tools12026 back to the surgeon's hands through the input control devices12036. The surgeon's console 12016 is usually located in the same roomas the patient 12012 so that the surgeon 12018 may directly monitor theprocedure, be physically present if necessary, and speak to an assistant12020 directly rather than over the telephone or other communicationmedium. However, the surgeon 12018 can be located in a different room, acompletely different building, or other remote location from the patient12012 allowing for remote surgical procedures. A sterile field can bedefined around the surgical site. In various instances, the surgeon12018 can be positioned outside the sterile field. A sterile adapter candefine a portion of the boundary of the sterile field. An example of asterile adapter for a robotic arm is described in U.S. PatentApplication Publication No. 2015/0257842, filed Mar. 17, 2015, titledBACKUP LATCH RELEASE FOR SURGICAL INSTRUMENT, which issued on Dec. 12,2017 as U.S. Pat. No. 9,839,487, which is herein incorporated byreference in its entirety.

Referring primarily now to FIG. 208, the electronics cart 12024 can becoupled with the endoscope 12028 and can include a processor to processcaptured images for subsequent display, such as to a surgeon on thesurgeon's console, or on another suitable display located locally and/orremotely. For example, where the stereoscopic endoscope 12028 is used,the electronics cart 12024 can process the captured images to presentthe surgeon with coordinated stereo images of the surgical site. Suchcoordination can include alignment between the opposing images and caninclude adjusting the stereo working distance of the stereoscopicendoscope. As another example, image processing can include the use ofpreviously determined camera calibration parameters to compensate forimaging errors of the image capture device, such as optical aberrations,for example.

FIG. 209 diagrammatically illustrates a robotic surgery system 12050,such as the MIRS system 12010 of FIG. 206. As discussed herein, asurgeon's console 12052, such as the surgeon's console 12016 in FIG.206, can be used by a surgeon to control a surgical robot 12054, such asthe surgical robot 12022 in FIG. 206, during a minimally invasiveprocedure. The surgical robot 12054 can use an imaging device, such as astereoscopic endoscope, to capture images of the procedure site andoutput the captured images to an electronics cart 12056, such as theelectronics cart 12024 in FIG. 206. As discussed herein, the electronicscart 12056 can process the captured images in a variety of ways prior toany subsequent display. For example, the electronics cart 12056 canoverlay the captured images with a virtual control interface prior todisplaying the combined images to the surgeon via the surgeon's console12052. The surgical robot 12054 can output the captured images forprocessing outside the electronics cart 12056. For example, the surgicalrobot 12054 can output the captured images to a processor 12058, whichcan be used to process the captured images. The images can also beprocessed by a combination of the electronics cart 12056 and theprocessor 12058, which can be coupled together to process the capturedimages jointly, sequentially, and/or combinations thereof. One or moreseparate displays 12060 can also be coupled with the processor 12058and/or the electronics cart 12056 for local and/or remote display ofimages, such as images of the procedure site, or other related images.

FIGS. 210 and 211 show the surgical robot 12022 and a robotic tool12062, respectively. The robotic tool 12062 is an example of the robotictools 12026 (FIG. 206). The reader will appreciate that alternativerobotic tools can be employed with the surgical robot 12022 andexemplary robotic tools are described herein. The surgical robot 12022shown provides for the manipulation of three robotic tools 12026 and theimaging device 12028, such as a stereoscopic endoscope used for thecapture of images of the site of the procedure. Manipulation is providedby robotic mechanisms having a number of robotic joints. The imagingdevice 12028 and the robotic tools 12026 can be positioned andmanipulated through incisions in the patient so that a kinematic remotecenter or virtual pivot is maintained at the incision to minimize thesize of the incision. Images of the surgical site can include images ofthe distal ends of the robotic tools 12026 when they are positionedwithin the field-of-view (FOV) of the imaging device 12028. Each tool12026 is detachable from and carried by a respective surgicalmanipulator 12031, which is located at the distal end of one or more ofthe robotic joints. The surgical manipulator 12031 provides a moveableplatform for moving the entirety of a tool 12026 with respect to thesurgical robot 12022, via movement of the robotic joints. The surgicalmanipulator 12031 also provides power to operate the robotic tool 12026using one or more mechanical and/or electrical interfaces.

FIG. 212 is a schematic of a telesurgically-controlled surgical system12100. The surgical system 12100 includes a surgeon console 12102, whichfor example can be the surgeon's console 12052 (FIG. 209). The surgeonconsole 12102 drives a surgical robot 12104, which for example can bethe surgical robot 12022 (FIG. 206). The surgical robot 12104 includes asurgical manipulator 12106, which for example can be the surgicalmanipulator 12031 (FIG. 210). The surgical manipulator 12106 includes amotor unit 12108 and a robotic tool 12110. The motor unit 12108 is acarriage assembly that holds five motors, which can be assigned todifferent mechanisms. In some exemplifications only five motors areused, while in other exemplifications more or less than five motors canbe used. The motor unit 12108 includes a power motor 12112, a camshaftmotor 12140, a pitch motor 12116, a yaw motor 12118, and low-force gripmotor 12120, although these motors can be used for different purposesdepending on the attached instrument. Generally, each motor is anelectric motor that mechanically and electrically couples withcorresponding inputs of the robotic tool 12110. In someexemplifications, the motor unit 12108 may be located at a proximal endof the robotic tool 12110 in a shared chassis with the robotic tool, asgenerally depicted by the proximal housing shown in FIG. 211. A motorhousing is further described in U.S. Patent Application Publication No.2012/0150192, filed Nov. 15, 2011, titled METHOD FOR PASSIVELYDECOUPLING TORQUE APPLIED BY A REMOTE ACTUATOR INTO AN INDEPENDENTLYROTATING MEMBER, which issued on Aug. 4, 2015 as U.S. Pat. No.9,095,362, which is herein incorporated by reference in its entirety.

The robotic tool 12110 for example, can be the robotic tool 12026 (FIG.206) described herein. The robotic tool 12110 includes an elongatedeffector unit 12122 that includes three discrete inputs that eachmechanically couple with the pitch motor 12116, the yaw motor 12118, andthe low-force grip motor 12120, respectively, by way of the surgicalmanipulator 12106. The robotic tool 12110 also includes a transmission12124, which mechanically couples with the power motor 12112 and thecamshaft motor 12140. Examples of tools are further described inInternational Patent Application Publication No. WO 2015/153642, filedMar. 31, 2015, titled SURGICAL INSTRUMENT WITH SHIFTABLE TRANSMISSION,and in International Patent Application Publication No. WO 2015/153636,filed Mar. 31, 2015, titled CONTROL INPUT ACCURACY FOR TELEOPERATEDSURGICAL INSTRUMENT, each of which is herein incorporated by referencein its entirety.

A surgical end effector 12126 is located at the distal end of theeffector unit 12122. The surgical end effector 12126 and effector unit12122 are connected by way of a moveable wrist. An example of such awrist is shown at U.S. Patent Application Publication No. 2011/0118708,filed Nov. 12, 2010, titled DOUBLE UNIVERSAL JOINT, and in U.S. Pat. No.9,216,062, filed Feb. 15, 2012, titled SEALS AND SEALING METHODS FOR ASURGICAL INSTRUMENT HAVING AN ARTICULATED END EFFECTOR ACTUATED BY ADRIVE SHAFT, each of which is herein incorporated by reference in itsentirety. In simplistic terms, the surgical end effector can becharacterized by a plurality of discrete but interrelated mechanisms,with each mechanism providing a degree of freedom (DOF) for the surgicalend effector 12126. As used herein with respect to surgical system12100, a DOF is one or more interrelated mechanisms for affecting acorresponding movement. The DOFs endow the surgical end effector 12126with different modes of operation that can operate concurrently ordiscretely. For example, the wrist enables the surgical end effector12126 to pitch and yaw with respect to the surgical manipulator 12106,and accordingly includes a pitch DOF 12128 and a yaw DOF 12130. Thesurgical end effector 12126 also includes a roll DOF 12132 rotatingsurgical end effector 12126 about an elongated axis. Different robotictool can have different DOFs, as further described herein.

The surgical end effector 12126 may include a clamping and cuttingmechanism, such as a surgical stapler. An example of such an instrument,including a staple cartridge therefor, is further described in U.S.Patent Application Publication No. 2013/0105552, filed Oct. 26, 2012,titled CARTRIDGE STATUS AND PRESENCE DETECTION, and U.S. PatentApplication Publication No. 2013/0105545, filed Oct. 26, 2012, titledSURGICAL INSTRUMENT WITH INTEGRAL KNIFE BLADE, both of which areincorporated by reference herein in their respective entireties. Aclamping mechanism can grip according to two modes, and accordinglyinclude two DOFs. A low-force DOF 12134 (e.g., a cable actuatedmechanism) operates to toggle the clamp with low force to gentlymanipulate tissue. The low-force DOF 12134 is useful for staging thesurgical end effector for a cutting or stapling operation. A high-forceDOF 12136 (e.g., a lead screw actuated mechanism) operates to furtheropen the clamp or close the clamp onto tissue with relatively highforce, for example, to tourniquet tissue in preparation for a cutting orstapling operation. Once clamped, the surgical end effector 12126employs a tool actuation DOF 12138 to further affect the tissue, forexample, to affect tissue by a stapling, cutting, and/or cauterizingdevice. Clamping systems for a surgical end effector are furtherdescribed in U.S. Pat. No. 9,393,017, filed May 15, 2012, titled METHODSAND SYSTEMS FOR DETECTING STAPLE CARTRIDGE MISFIRE OR FAILURE, whichissued on Jul. 19, 2016, U.S. Pat. No. 8,989,903, filed Jan. 13, 2012,titled METHODS AND SYSTEMS FOR INDICATING A CLAMPING PREDICTION, whichissued on Mar. 2, 2015, and U.S. Pat. No. 9,662,177, filed Mar. 2, 2015,titled METHODS AND SYSTEMS FOR INDICATING A CLAMPING PREDICTION, whichissued on May 30, 2017, all of which are incorporated by referenceherein in their respective entireties.

As shown in FIG. 212, the pitch motor 12116, the yaw motor 12118, andthe low-force grip motor 12120 drive the pitch DOF 12128, the yaw DOF12130, and the low-force grip DOF 12134, respectively. Accordingly, eachof the pitch DOF 12128, the yaw DOF 12130, and the low force grip DOF12134 is discretely paired with a motor, and can operate independentlyand concurrently with respect to other DOFs. However, the high forcegrip DOF 12136, the roll DOF 12132, and the tool actuation DOF 12138share a single input with the power motor 12112, via the transmission12124. Accordingly, only one of the high-force grip DOF 12136, the rollDOF 12132, and the tool actuation DOF 12138 can operate at one time,since coupling with the power motor 12112 occurs discretely. Thecamshaft motor 12140 is actuated to shift output of the power motor12112 between the high force grip DOF 12136, the roll DOF 12132, and thetool actuation DOF 12138. Accordingly, the transmission 12124advantageously allows a greater amount of DOFs than an arrangement whereeach motor is dedicated to a single DOF.

Additional features and operations of a surgical robotic system, such asthe robotic surgical system of FIGS. 206-212, are further described inthe following references, which are herein incorporated by reference intheir respective entireties:

-   -   U.S. Patent Application Publication No. 2011/0118708, filed Nov.        12, 2010, titled DOUBLE UNIVERSAL JOINT;    -   U.S. Pat. No. 9,095,362, filed Nov. 15, 2011, titled METHOD FOR        PASSIVELY DECOUPLING TORQUE APPLIED BY A REMOTE ACTUATOR INTO AN        INDEPENDENTLY ROTATING MEMBER, which issued on Aug. 4, 2015;    -   U.S. Pat. No. 8,989,903, filed Jan. 13, 2012, titled METHODS AND        SYSTEMS FOR INDICATING A CLAMPING PREDICTION, which issued on        Mar. 24, 2015;    -   U.S. Pat. No. 9,216,062, filed Feb. 15, 2012, titled SEALS AND        SEALING METHODS FOR A SURGICAL INSTRUMENT HAVING AN ARTICULATED        END EFFECTOR ACTUATED BY A DRIVE SHAFT, which issued on Dec. 22,        2015;    -   U.S. Pat. No. 9,393,017, filed May 15, 2012, titled METHODS AND        SYSTEMS FOR DETECTING STAPLE CARTRIDGE MISFIRE OR FAILURE, which        issued on Jul. 19, 2016;    -   U.S. Patent Application Publication No. 2013/0105552, filed Oct.        26, 2012, titled CARTRIDGE STATUS AND PRESENCE DETECTION;    -   U.S. Patent Application Publication No. 2013/0105545, filed Oct.        26, 2012, titled SURGICAL INSTRUMENT WITH INTEGRAL KNIFE BLADE;    -   International Patent Application Publication No. WO 2015/142814,        filed Mar. 17, 2015, titled SURGICAL CANNULA MOUNTS AND RELATED        SYSTEMS AND METHODS;    -   U.S. Patent Application Publication No. 2015/0257842, filed Mar.        17, 2015, titled BACKUP LATCH RELEASE FOR SURGICAL INSTRUMENT,        which issued on Dec. 12, 2017 as U.S. Pat. No. 9,839,487;    -   U.S. Patent Application Publication No. 2015/0257841, filed Mar.        17, 2015, titled LATCH RELEASE FOR SURGICAL INSTRUMENT;    -   International Patent Application Publication No. WO 2015/153642,        filed Mar. 31, 2015, titled SURGICAL INSTRUMENT WITH SHIFTABLE        TRANSMISSION;    -   International Patent Application Publication No. WO 2015/153636,        filed Mar. 31, 2015, titled CONTROL INPUT ACCURACY FOR        TELEOPERATED SURGICAL INSTRUMENT; and    -   U.S. Pat. No. 9,662,177, filed Mar. 2, 2015, titled METHODS AND        SYSTEMS FOR INDICATING A CLAMPING PREDICTION, which issued on        May 30, 2017.

The robotic surgical systems and features disclosed herein can beemployed with the da Vinci® surgical robotic system referenced hereinand/or the system of FIGS. 206-212. The reader will further appreciatethat various systems and/or features disclosed herein can also beemployed with alternative surgical systems including thecomputer-implemented interactive surgical system 100, thecomputer-implemented interactive surgical system 200, the roboticsurgical system 110, the robotic hub 122, the robotic hub 222, and/orthe robotic surgical system 15000, for example.

In various instances, a robotic surgical system can include a roboticcontrol tower, which can house the control unit of the system. Forexample, the processor 12058 (FIG. 209) can be housed within a roboticcontrol tower. The robotic control tower can comprise a robot hub suchas the robotic hub 122 (FIG. 2) or the robotic hub 222 (FIG. 9), forexample. Such a robotic hub can include a modular interface for couplingwith one or more generators, such as an ultrasonic generator and/or aradio frequency generator, and/or one or more modules, such as animaging module, a suction module, an irrigation module, a smokeevacuation module, and/or a communication module.

A robotic hub can include a situational awareness module, which can beconfigured to synthesize data from multiple sources to determine anappropriate response to a surgical event. For example, a situationalawareness module can determine the type of surgical procedure, step inthe surgical procedure, type of tissue, and/or tissue characteristics,as further described herein. Moreover, such a module can recommend aparticular course of action or possible choices based on the synthesizeddata. In various instances, a sensor system encompassing a plurality ofsensors distributed throughout the robotic system can provide data,images, and/or other information to the situational awareness module.Such a situational awareness module can be accessible to the processor12058, for example. In various instances, the situational awarenessmodule can obtain data and/or information from a non-robotic surgicalhub and/or a cloud, such as the surgical hub 106 (FIG. 1), the surgicalhub 206 (FIG. 10), the cloud 104 (FIG. 1), and/or the cloud 204 (FIG.9), for example. Situational awareness of a surgical system is furtherdisclosed herein and in U.S. Provisional Patent Application Ser. No.62/611,341, titled INTERACTIVE SURGICAL PLATFORM, filed Dec. 28, 2017,and in U.S. Provisional Patent Application Ser. No. 62/611,340, titledCLOUD-BASED MEDICAL ANALYTICS, filed Dec. 28, 2017, the disclosure ofeach of which is herein incorporated by reference in its entirety.

Surgical systems including a robot, a visualization system (such as thevisualization system 108 or the visualization system 208), and one ormore hubs (such as the hub 106, the robotic hub 122, the hub 206, and/orthe robotic hub 222) can benefit from robust communication systems fordata collection and dissemination. For example, various parametersregarding the surgical site, the surgical instrument(s), and/or thesurgical procedure can be important information to the robot, thevisualization system, and the hub(s). Moreover, the robot can includeone or more subassemblies, such as a control console, which may requireinformation regarding the surgical site, the surgical instrument(s),and/or the surgical procedure, for example. It can be helpful to collectand disseminate the information to the appropriate assemblies and/orsubassemblies in real-time or near real-time to inform the machinelearning and/or decision-making process, for example. In certaininstances, data collection and dissemination can inform the situationalawareness of a surgical system that includes one or more roboticsystems.

In one aspect, a robotic surgical system can include additionalcommunication paths. For example, a robotic surgical system can includea primary wired communication path and a secondary wirelesscommunication path. In certain instances, the two communication pathscan be independent such that a secondary path is redundant and/orparallel to a primary path. In various instances, a first type and/oramount of data can be transferred along the primary path and a secondtype and/or amount of data can be transferred along the secondary path.The multiple communication paths can improve connectivity of the robotand/or the robotic surgical tools to one or more displays within thesurgical theater, a control console, and/or control unit. Thecommunication paths can connect a surgical robot to a central controlunit (e.g. a hub) and/or a visualization system (e.g. a display), forexample. In various instances, the additional communication paths canprovide additional data to the robot and/or to a generator module and/ora processor in communication with the generator module.

Referring primarily to FIG. 213, a robotic surgical system 12200including a console 12216 and a robot 12222 is depicted. The console12216 can be similar in many respects to the console 12016 (FIGS. 206and 207), and the robot 12222 can be similar in many respects to therobot 12022 (FIGS. 206 and 210). A robotic tool 12226, which can besimilar in many respects to the robotic tool 12026 (FIG. 206), forexample, is positioned at the distal end of one of the arms of the robot12222. The robotic tool 12226 is an energy device. For example, energycan be supplied to the robotic tool 12226 by a generator that is coupledto the robotic tool 12226.

The robotic surgical system 12200 also includes a hub 12224, which canbe similar in many respects to the robotic hub 122 (FIG. 2) and/or therobotic hub 222 (FIG. 9). The hub 12224 includes a generator module12230, which is similar in many respects to the generator module 140(FIG. 3), and a wireless communication module 12238, which is similar inmany respects to the communication module 130 (FIG. 3). The generatormodule 12230 is configured to supply energy to the robotic tool 12226via a first wired connection 12244.

In one instance, the first wired connection 12244 can be a two-waycommunication path between the robotic tool 12226 and the surgical hub12224. The first wired connection 12244 can convey advanced energyparameters or other electrical data between the robotic tool 12226 andthe surgical hub 12224. For example, the surgical hub 12224 can provideinformation to the robotic tool 12226 regarding the power level (e.g.current for an RF device and amplitude and/or frequency for anultrasonic device) supplied thereto. Additionally, the robotic tool12226 can provide information to the robot 12222 regarding the detectedconductivity and/or impendence at the tissue interface, corresponding toa property of the tissue and/or the effectiveness of the energy device.

Additionally, a second wired connection 12240 between the console 12216and the robotic tool 12226 mounted to the robot 12222 provides acommunication path for control signals from the robot console 12216 tothe robotic tool 12226. In one instance, the second wired connection12240 can be a one-way communication path from the robot 12222 to theconsole 12216 with respect to control parameters or other mechanicaldata collected by the robot 12222 and/or the robotic tool 12226. Forexample, the robot 12222 can provide information to the console 12216about a surgical actuation of the robotic tool, such as a closing motionand/or a firing motion. More specifically, the robot can communicateforce-to-clamp parameters (e.g. clamping pressure by the robotic tool12226 on tissue) and/or force-to-fire parameters from the robotic tool12226 to the console 12216, for example.

Referring still to FIG. 213, absent the wireless communication paths12242 and 12246, the robotic hub 12224 may be unable to communicate withthe console 12216 and vice versa. Additionally, the robotic tool 12226may be unable to communicate with the hub 12224. In instances in whichcommunication paths between the hub 12224 and the robot 12222 and/or therobotic tool 12226 are lacking, the mechanical control parameters (e.g.clamping force) from the robotic tool 12226 may not be communicated tothe robotic hub 12224 and the generator module 12230 thereof.Additionally, electrical advanced energy parameters may not becommunicated from the robot 12222 to the robotic hub 12224 and/or to theconsole 12216. In such instances, the system 12200 would compriseopen-loop controls.

Different energy parameters and different clamping pressures may bebetter suited for certain types of tissue and/or certain applications.For example, an ultrasonic weld is generally a function of transduceramplitude and clamping pressure over time. Similarly, an RF weld isgenerally a function of current and clamping pressure over time.However, without the wireless communication paths 12242 and 12246mentioned above, the generator module 12230 can be unaware of theclamping pressure. Similarly, the console 12216 can be unaware of theenergy parameters.

To optimize the control of the robotic tool 12226, the robotic tool12226 can convey one or more mechanical control parameters to therobotic hub 12224. Additionally, the hub 12224 can convey one or moreadvanced energy parameters to the console 12216. The data transfer canprovide closed-loop controls for the system 12200. In one instance, themechanical control parameters and advanced energy parameters can bebalanced for different types of tissue and/or particular applications.For example, the clamping pressure can be decreased and the power to therobotic tool 12226 can be increased, or vice versa.

Referring still to FIG. 213, the robotic tool 12226 includes a wirelesscommunication module 12228, as further described herein. The wirelesscommunication module 12228 is in signal communication with the wirelesscommunication module 12238 of the robotic hub 12224 via the wirelesscommunication path 12242. For example, the wireless communication module12238 can include a first receiver 12232 configured to receive wirelesssignals from the robotic tool 12226. The wireless communication module12238 also includes a second receiver 12234, which can receive signalsfrom the console 12216 via the second wireless communication path 12246.In such instances, the first and second wireless communication paths12242 and 12246, respectively, can complete a communication circuit backto the console 12216 from the robotic tool 12226 via the surgical hub12224, for example.

In other instances, the wireless communication module 12228 can be onthe robot 12222. For example, the wireless communication module 12228can be positioned on an arm of the robot and/or a tool mounting portionof the robot 12222.

Additionally or alternatively, a wireless communication path can beprovided between the robotic tool 12226 and the console 12216.

The wireless paths described herein can provide data transfer withoutencumbering the mobility of the robotic tool 12226 and/or creatingadditional opportunities for entanglement or cords and/or wires. Inother instances, one or more of the wireless communication pathsdescribed herein can be replaced with wired connection(s).

In one aspect, the robotic tool 12226 and/or the hub 12224 can shareinformation regarding sensed tissue parameters (e.g. conductivity orinductance corresponding to a property of the tissue) and/or controlalgorithms for energizing the tissue (e.g. power levels), which can bebased on the sensed tissue parameters. The robotic tool 12226 canprovide information regarding the status, the activation state,identification information, and/or smart data to the hub 12224, forexample. Data provided to the hub 12224 can be stored, analyzed, and/orfurther disseminated by the hub 12224 such as to a display screen 12236thereof. In such instances, the hub 12224 is a conduit or relay post fortransmitting the data to additional locations via the wired or wirelessconnections.

In certain instances, the hub 12224 includes a situational awarenessmodule, as further described herein. The situational awareness modulecan be configured to determine and/or confirm a step in a surgicalprocedure and/or suggest a particular surgical action based oninformation received from various sources, including the robot 12222 andthe console 12216. The wireless communication paths 12242 and 12246linking the hub 12224 to the robot 12222 and the console 12216,respectively, can be configured to inform the situational awarenessmodule. For example, mechanical control parameters regarding clampingand/or firing can be communicated to the hub 12224 and the situationalawareness module thereof via the second wireless communication path12246. Additionally or alternatively, energy parameters regardingactivation of the energy tool and/or sensed tissue parameters can becommunicated to the hub 12224 and the situational awareness modulethereof via the first wireless communication path 12242.

In certain instances, the data wirelessly transmitted to the hub 12224can inform the situational awareness module thereof. For example, basedon sensed tissue parameters detected by the robotic tool 12226 andtransmitted along the first wireless communication path 12242, thesituational awareness module can determine and/or confirm the type oftissue involved in the surgical procedure and, in certain instances, cansuggest a therapeutic response based on the type of tissue encountered.

Referring still to FIG. 213, the second wired connection 12240 from therobot 12222 to the console 12216 provides a first communication path.Moreover, the wired or wireless connection between the robot 12222 andthe hub 12224 in combination with the wireless communication path 12246between the hub 12224 and the console 12216 forms a second, parallelcommunication path from the robot 12222 to the console 12212. Becausethe second communication path communicates via the hub 12224 and thewireless communication module 12238 thereof, the second communicationpath is different than the first communication path. However, such apath provides a parallel and alternative path to the second wiredconnection 12240 between the robot 12222 and the console 12216.Similarly, parallel and/or redundant paths are also provided via thewireless path 12242 and the wired path 12244 between the robot 12222 andthe hub 12224. The alternative parallel communication path(s) canbolster the integrity of the communications systems and enables robotcommunication between the various components of the surgical system.

Additionally or alternatively, information may be communicated directlyto a device or system having wireless capabilities such as avisualization system or display like the visualization system 108 or thevisualization system 208, for example. A surgical system 12300 depictedin FIG. 238 includes the console 12216 for a surgeon S, the robot 12222including the robotic tool 12226 mounted thereto, and the surgical hub12224. The surgical system 12300 also includes a monitor 12350, which ispositioned within the surgical theater. Additional clinicians can bewithin the surgical theater including a nurse N, a medical assistant MA,and an anesthesiologist A. Certain clinicians can be positioned withinthe sterile field. For example, the nurse N, who is stationed at a table12352 supporting a plurality of medical instruments and robotic tools,can be sterile. The medical assistant MA holding the handheld surgicalinstrument and the anesthesiologist A may be positioned outside thesterile field. The monitor 12350 is viewable by clinicians within thesterile field and outside the sterile field. An additional display 12354can be positioned within the sterile field. The additional display 12354can be a mobile computer with wireless, cellular and/or Bluetoothcapabilities, for example. In one instance, the additional display 12354can be a tablet, such as an iPad® tablet, that is positionable on thepatient P or patient table 12358. In such instances, the display 12354is positioned within the sterile field.

The wireless communication module 12228 (FIG. 213) on the robotic tool12226 can be in signal communication with the monitor 12350 and/or thedisplay 12354. In such instances, data and/or information obtained atthe surgical site and/or by the robotic tool 12226 can be directlycommunicated to a screen within the surgical theater and immediatelyviewable to various clinicians with the surgical theater, includingclinicians within the sterile field or outside the sterile field. Insuch instances, data can be provided in real time, or near real time, toinform the clinicians' decisions during the surgical procedure.Additionally, certain information can be communicated to the hub 12224for further storage, analysis and/or dissemination, as further describedherein.

Owing to wireless communication paths, the monitor 12350 and/or thedisplay 12354 can also display information from the hub, includingenergy parameters, in certain instances. For example, the hub 12224 canobtain data indicative of an activation state or activation level of thegenerator module 12230 (FIG. 213) and/or can receive data indicative ofsensed tissue parameters from the robotic tool 12226, as furtherdescribed herein. In such instances, the activation information and/ortissue information can be displayed on the monitor 12350 and/or thedisplay 12354 such that the information is readily available tooperators both within the sterile filed and outside the sterile field.

In one aspect, the hub 12224 can ultimately communicate with a cloud,such as the cloud 104 or the cloud 204, for example, to further informthe machine-learning and decision-making processes related to theadvanced energy parameters and/or mechanical control parameters of therobotic tool 12226. For example, a cloud can determine an appropriatesurgical action and/or therapeutic response for a particular tissueparameter, surgical procedure, and/or patient demographic based onaggregated data stored therein. To protect patient confidentiality, thehub 12224 can communicate redacted and/or a confidential version of thedata, for example.

As described herein with respect to FIG. 213, the robotic tool 12226includes the wireless communication module 12228. The wirelesscommunication module 12228 is also shown in FIG. 214. Specifically, aproximal portion of the robotic tool 12226 including the wirelesscommunication module 12228 is depicted in FIG. 214, as well as a toolmounting portion, or attachment portion, 12250 of the robot 12222 forreleasably attaching the proximal housing of the robotic tool 12226. Adetailed view of a mechanical and electrical interface between therobotic tool 12226 and the tool mounting portion 12250 is depicted inFIG. 215.

The robotic tool 12226 includes a first drive interface 12252 thatdrivingly couples with a second drive interface 12254 on the toolmounting portion 12250. The tool mounting portion 12250 includes acarriage or motor housing that houses a plurality of motors, which canbe similar in many respects to the motors 12112, 12116, 12118, 12120,and 12140 (FIG. 212), for example. The motors are driving coupled torotary outputs 12256 at the second drive interface 12254 that engagerotary inputs 12258 on the robotic tool 12226. For example, the rotaryinputs 12258 are positioned and structured to mechanically mate with therotary outputs 12256 on the tool mounting portion 12250.

A plug 12260 for supplying power to the motors is shown in FIG. 214. Theplug 12260 is also coupled to the wireless communication module 12228.In such instances, the wireless communication module 12228 can bepowered via a current supplied by the plug 12260. The plug 12260 canultimately be wired to the generator module 12230 in the hub 12224 tocomplete the wired connection 12244 between the robotic tool 12226 andthe hub 12224 (see FIG. 213).

Referring primarily now to FIG. 214, the tool mounting portion 12250also includes electrical contacts 12262, and the robotic tool 12226includes electrical contacts 12264 positioned and structured to matewith the electrical contacts 12262 on the tool mounting portion 12250.Electrical signals can be communicated between the robotic tool 12226and the robot 12222 (FIG. 213) via the mating electrical contacts 12262,12264. In certain instances, mechanical control parameters from therobotic tool 12262 can be communicated to the robot 12222 via theelectrical contacts 12262, 12264, as further described herein.Additionally or alternatively, advanced energy parameters can becommunicated to the robot 12222 and/or to the robotic tool 12226 via themating electrical contacts 12262, 12264, or vice versa, as furtherdescribed herein.

As depicted in FIG. 215, when the robotic tool 12226 is mounted to thetool mounting portion 12250, a flex circuit 12270 is positionedintermediate the mating electrical contacts 12264 of the robotic tool12226 and the electrical contacts 12262 of the tool mounting portion12250 to facilitate data transmission. The flex circuit 12270 ispositioned to intercept communication signals between the robotic tool12262 and the tool mounting portion 12250. In such instances, the flexcircuit 12270 is configured to capture signals passing between thosecontacts 12262, 12264. In certain instances, the flex circuit 12270 canprovide intelligence features to the robotic tool 12226.

In various instances, the flex circuit 12270 can include a feedbackpigtail connector. The pigtail connector can intercept the connectionbetween the robotic tool 12226 and the tool mounting portion 12250.

In various instances, the flex circuit 12270 of FIG. 214 can alsoinclude a wireless transmitter that is configured to communicate withthe hub 12224 (FIG. 213) via the wireless communication path 12242. Inother instances, the flex circuit 12270 can be coupled to a wirelesscommunication module like the module 12228 in FIGS. 213 and 214, whichcan include a wireless transmitter and/or a wireless receiver.

The flex circuit 12270 occupies a small footprint between the toolmounting portion 12250 and the robotic tool 12226. In one aspect,existing robotic systems can be retrofit with such flex circuits. Inother words, existing robotic tools and tool mounting portion canutilize the robust communication systems described herein withoutmodifying the current robotic tools and/or tool mounting portions.

In various instances, the flex circuit 12270, or another intermediatepigtail connector, can be configured to acquire one or more signalsbetween an external controller (e.g., an energy generator of a generatormodule 140 in a hub 106 (FIG. 3)) and the robotic tool 12226. Moreover,such a circuit or connector can be used to deliver signals to therobotic tool 12226 via the intercepting connections.

In one aspect, the robotic hub includes a processor and a memorycommunicatively coupled to the processor, as described herein. Thememory stores instructions executable by the processor to relay awireless signal between a robot and a control console, as describedherein. In certain instances, the memory stores instructions executableby the processor to adjust a control parameter of the generator (e.g.power level) based on signals intercepted by a flex circuit and/ortransmitted along a wireless communication path. Additionally oralternatively, the memory stores instructions executable by theprocessor to adjust a control parameter of the energy tool (e.g.clamping pressure) based on signals indicative of a tissue propertyintercepted by the flex circuit and/or transmitted along the wirelesscommunication path.

In various aspects, the present disclosure provides a control circuit torelay a wireless signal between a robot and a control console, adjust acontrol parameter of the generator, and/or adjust a control parameter ofan energy tool, as described herein. In various aspects, the presentdisclosure provides a non-transitory computer readable medium storingcomputer readable instructions which, when executed, cause a machine torelay a wireless signal between a robot and a control console, adjust acontrol parameter of the generator, and/or adjust a control parameter ofan energy tool, as described herein.

In one aspect, one or more features and/or effects of arobotically-controlled surgical tool and end effector thereof can becontrolled by a control algorithm. For example, the intensity of an endeffector effect can be controlled by a control algorithm stored in thememory of the robot and executable by a processor. In one instance, anend effector effect can be smoke evacuation, insufflation, and/orcooling. In another instance, an end effector effect can be articulationand/or retraction. As an example, a robot can implement a load controlholding algorithm for articulation of a robotic tool that results in apredefined lateral load on tissue and is limited by a displacementlimit, as further described herein.

In certain instances, it can be desirable to incorporate a pump into arobotically-controlled surgical tool, such as an energy tool includingan RF electrode and/or an ultrasonic blade, for example. A pump canprovide insufflation gases or air to a surgical site. In certaininstances, a pump can provide coolant to a surgical site and/or canextract smoke and/or steam from the surgical site.

Robotically-controlled surgical tools include a drive system forreleasably engaging with a robot and transferring drive motions from therobot to the robotic tool. For example, a robotically-controlledsurgical tool can include an interface including rotary driver(s)configured to receive rotary inputs from motor(s) in a motor housing ortool mounting portion. Exemplary drive systems and interfaces thereforare further described herein.

The rotary drivers in the robotic tools are configured to actuatevarious surgical functions such as rotation of a shaft, closure of endeffector jaws, and articulation of the end effector, for example.Examples of interface configurations are further described herein and inInternational Patent Application Publication No. WO 2015/153642, filedMar. 31, 2015, titled SURGICAL INSTRUMENT WITH SHIFTABLE TRANSMISSION,in International Patent Application Publication No. WO 2015/153636,filed Mar. 31, 2015, titled CONTROL INPUT ACCURACY FOR TELEOPERATEDSURGICAL INSTRUMENT, and in U.S. Pat. No. 9,095,362, filed Nov. 15,2011, titled METHOD FOR PASSIVELY DECOUPLING TORQUE APPLIED BY A REMOTEACTUATOR INTO AN INDEPENDENTLY ROTATING MEMBER, each of which is hereinincorporated by reference in its entirety.

In certain instances, the number of motors, the number of rotarydrivers, and/or the arrangements of motors and/or rotary drivers can belimited or constrained by the footprint of the drive system and/orcoupling between the robotic tool and the tool mounting portion. In oneaspect, it can be desirable for new and/or improvedrobotically-controlled surgical tools to be compatible with existingrobotic platforms. For example, without enlarging the motor housing ortool mounting portion, it can be desirable to change the functionalityand/or add functionality to robotic tools for use with an existing motorhousing and tool mounting portion. In such instances, it can bechallenging to incorporate certain features, like a pump for example,into a robotic tool compatible with an existing surgical robot.Moreover, it can be desirable to include controls and/or controlalgorithms for such a pump within the existing architecture of thesurgical robot.

In one aspect, a pump for a robotic tool can be powered by a rotarydrive of the robotic tool interface. The rotary drive and, thus, thepump can be driven at a variable rate, which can depend on the needs ofthe robotic tool and/or the surgical procedure. For example, the speedof the rotary drive coupled to the pump can be related to the volume ofsmoke being evacuated from the surgical site and/or the application ofenergy to tissue by the robotic tool. In one instance, the robotic toolcan be an intelligent tool that includes a processor configured todetermine the appropriate rate for the pump based on sensors on therobotic tool and/or other inputs thereto. In other instances, aprocessor in the control unit of the robot can be configured todetermine the appropriate rate for the pump based on sensors on therobot and/or modules thereof, such as a smoke evacuation module in arobotic hub, for example.

Energy devices utilize energy to affect tissue. In an energy device, theenergy is supplied by a generator. Energy devices include devices withtissue-contacting electrodes, such as an electrosurgical device havingone or more radio frequency (RF) electrodes, and devices with vibratingsurfaces, such as an ultrasonic device having an ultrasonic blade. Foran electrosurgical device, a generator is configured to generateoscillating electric currents to energize the electrodes. For anultrasonic device, a generator is configured to generate ultrasonicvibrations to energize the ultrasonic blade.

As provided herein, energy devices deliver mechanical or electricalenergy to a target tissue in order to treat the tissue (e.g. to cut thetissue and/or cauterize blood vessels within and/or near the targettissue). The cutting and/or cauterization of tissue can result in fluidsand/or particulates being released into the air. Such fluids and/orparticulates emitted during a surgical procedure can constitute smoke,for example, which can include carbon and/or other particles suspendedin air.

In various instances, an energy tool for use with a robotic system caninclude a suction port coupled to a pump that is powered by a motor onthe tool driver. For example, an energy tool for the da Vinci® surgicalrobotic system can include a suction port coupled to a pump that ispowered by a motor on the tool driver. The pump can be configured toextract smoke from a surgical site via the suction port. In suchinstances, the energy tool can include a smoke evacuation system. In oneaspect, the robotic tool can include a pump. Alternatively, the robotictool can be coupled to a pump.

The reader will appreciate that such an evacuation system can bereferred to as a “smoke evacuation system” though such an evacuationsystem can be configured to evacuate more than just smoke from asurgical site. Throughout the present disclosure, the “smoke” evacuatedby an evacuation system is not limited to just smoke. Rather, theevacuation systems disclosed herein can be used to evacuate a variety offluids, including liquids, gases, vapors, smoke, steam, or combinationsthereon. The fluids can be biologic in origin and/or can be introducedto the surgical site from an external source during a procedure. Thefluids can include water, saline, lymph, blood, exudate, and/or pyogenicdischarge, for example. Moreover, the fluids can include particulates orother matter (e.g. cellular matter or debris) that is evacuated by theevacuation system. For example, such particulates can be suspended inthe fluid.

Referring primarily to FIGS. 216-218, a robotic tool 12426 for use witha robotic surgical system is depicted. The robotic tool 12426 can beemployed with the robotic surgical system 12010 (FIG. 206), for example.The robotic tool 12426 is a bipolar radio-frequency (RF) robotic tool.For example, the tool can be similar in many respects to the tooldisclosed in U.S. Pat. No. 8,771,270, filed on Jul. 16, 2008, titledBIPOLAR CAUTERY INSTRUMENT, which is herein incorporated by reference inits entirety.

In other instances, the robotic tool 12426 can be a monopolar RF tool,an ultrasonic tool, or a combination ultrasonic-RF tool. For example,the robotic tool 12426 can be similar in many similar to the tooldisclosed in U.S. Pat. No. 9,314,308, filed Mar. 13, 2013, titledROBOTIC ULTRASONIC SURGICAL DEVICE WITH ARTICULATING END EFFECTOR, whichis herein incorporated by reference in its entirety.

The robotic tool 12426 includes a proximal housing 12437, a shaft 12438extending from the proximal housing 12437, and an end effector 12428extending from a distal end of the shaft 12438. Referring primarily toFIG. 217, the end effector 12428 includes opposing jaws 12430 a, 12430b. Each jaw 12430 a, 12430 b includes a tissue-contacting surfaceincluding an electrode. For example, the jaw 12430 a can include asupply electrode, and the jaw 12430 b can include a return electrode, orvice versa. The end effector 12428 is shown in a clamped configurationand generating an RF weld in FIG. 217. In such instances, smoke S fromthe RF weld may accumulate around the end effector 12428. For example,the smoke S can accumulate in the abdomen of a patient in certaininstances.

The robotic tool 12426 also includes an evacuation system 12436. Forexample, to improve visibility and efficiency of the robotic tool 12426,the smoke S at the surgical site can be evacuated along an evacuationchannel, or suction conduit, 12440 extending proximally from the endeffector 12428. The evacuation channel 12440 can extend through theshaft 12438 of the robotic tool 12426 to the proximal housing 12437. Theevacuation conduit 12440 terminates at a suction port 12442 adjacent tothe end effector 12428. During operating of the evacuation system 12436,smoke S at the surgical site is drawn into the suction port 12442 andthrough the evacuation conduit 12440.

In various instances, the robotic tool 12426 can include insufflation,cooling, and/or irrigation capabilities, as well. For example, theevacuation system 12436 can be configured to selectively pump a fluid,such as saline or CO₂ for example, toward the end effector 12428 andinto the surgical site.

In various instances, the evacuation channel 12440 can be coupled to apump for drawing the smoke S along the evacuation channel 12440 withinthe shaft 12438 of the robotic tool 12426. Referring primarily to FIG.218, the evacuation system 12436 includes a pump 12446. The pump 12446is housed in the proximal housing 12437 of the robotic tool 12426. Thepump 12446 is a lobe pump, which has been incorporated into a driveinterface 12448 of the robotic tool 12426. The drive interface 12448includes rotary drivers 12450, which are driven by rotary outputs frommotors in the tool mounting portion of the robot, as described herein(see rotary outputs 12256 (FIG. 214) and rotary outputs 12824 a-12824 e(FIG. 222), for example).

Lobe pumps can be low volume and quiet or noiseless and, thus, desirablein certain instances. For example, a lobe pump can ensure the noisegenerated by the evacuation system 12436 is not distracting to theclinicians and/or allows communication between clinicians in thesurgical theater. The reader will readily appreciate that differentpumps can be utilized by the evacuation system 12436 in other instances.

A channel 12452 terminating in a fitting 12454 extends from the pump12446 in FIGS. 216 and 218. The fitting 12454 is a luer fitting,however, the reader will readily appreciate that alternative fittingsare envisioned. The luer fitting can be selectively coupled to areservoir that is configured to receive the smoke S from the surgicalsite, for example. Additionally or alternatively, the luer fitting cansupply discharge from the pump 12446 to a filter.

Referring still to FIG. 218, internal components of the drive interface12448 are depicted, however, certain components are excluded forclarity. The evacuation channel 12440 extends through the shaft 12438 tothe lobe pump 12446 in the proximal housing 12437. The pump 12446 isdriven by a rotary driver 12450 of the interface 12448. In variousinstances, the interface 12448 can include four rotary drivers 12450. Inone example, a first rotary driver 12450 is configured to power anarticulation motion, a second rotary driver 12450 is configured to powera jaw closure motion, a third rotary driver 12450 is configured to powera shaft rotation, and a fourth rotary driver 12450 is configured topower the pump 12446. The reader will appreciate that alternativeinterface arrangements can include more than or less than four rotarydrivers 12450. Additionally, the drive motions generated by the rotarydrivers 12450 can vary depending on the desired functionality of therobotic tool 12426. Moreover, in certain instances, the drive interface12448 can include a transmission or shifter such that the rotary drivers12450 can shift between multiple surgical functions, as furtherdescribed herein (see transmission 12124 in FIG. 212 and transmissionassembly 12840 in FIGS. 223-228, for example). In one instance, therotary driver 12450 coupled to the pump 12446 can also actuate aclamping motion of the end effector 12428, for example.

In one aspect, activation of the pump 12446 of the robotic tool 12426can be coordinated with the application of energy by the robotic tool12426. In various instances, a control algorithm for the rotary driver12450 for the pump 12446 can be related to the rate at which smoke S isextracted from the surgical site. In such instances, the robot (e.g. therobot 12022 in FIGS. 206 and 210) can have direct control over thevolume of evacuation and/or extraction from the surgical site.

In one instance, the on/off control for the pump 12446 is controlledbased on inputs from a camera, such as the camera of the imaging device124 (FIG. 2) like an endoscope, for example. The imaging device 124 canbe configured to detect the presence of smoke S in a visual field at thesurgical site. In another aspect, the on/off control for the pump 12446is controlled based on inputs from a smoke sensor 12453 (FIG. 217)in-line with the fluid being pumped out of the patient. For example, thepump 12446 can remain on as long as a threshold amount of smoke S isdetected by the smoke sensor 12453 and can be turned off or paused whenthe detected volume of smoke S falls below the threshold amount. Instill another aspect, the pump 12446 is turned on when energy isactivated and, in certain instances, can remain on for a period of timeafter the energy has been stopped. The duration of time for which thepump 12446 can remain on after the energy has stopped may be fixed ormay be proportional to the length of time the energy was activated, forexample.

Referring primarily to FIG. 220, a flow chart depicting logic steps foroperating a pump, such as the pump 12446, is depicted. A processor forthe robot (e.g. robot 12022) and/or a processor of a hub (e.g. hub 106,hub 206, robotic hub 122, and robotic hub 222) that is in signalcommunication with the robot can determine or estimate the rate of smokeevacuation from the surgical site. The rate of smoke evacuation can bedetermined at step 12510 by one or more factors or inputs including theactivation of energy by the robotic tool (a first input 12502), a smokesensor in-line with the smoke evacuation channel (a second input 12504),and/or an imaging device configured to view the surgical site (a thirdinput 12506). The first input 12502 can correspond to the duration ofenergy application and/or the power level, for example. Based on the oneor more factors, the pump can be adjusted at step 12512. For example,the rate at which the rotary driver drives the pump can be adjusted. Inother instances, the rotary driver can stop or pause the operation ofthe pump while the detected rate of smoke evacuation is below athreshold volume. The flow chart of FIG. 220 can continue throughout theoperation of a robotic tool. In certain instances, the steps 12510 and12512 can be repeated at predefined intervals during a surgicalprocedure and/or when requested by a clinician and/or recommend by ahub.

Referring now to FIG. 219, a robotic tool 12526 for use with a roboticsurgical system is depicted. The robotic tool 12526 can be employed withthe robotic surgical system 12010 (FIG. 206), for example. The robotictool 12526 is an ultrasonic robotic tool having cooling and insufflationcapabilities. For example, the robotic tool 12526 can be similar in manyrespects to the robotic tool disclosed in U.S. Pat. No. 9,314,308, filedMar. 13, 2013, titled ROBOTIC ULTRASONIC SURGICAL DEVICE WITHARTICULATING END EFFECTOR, which is herein incorporated by reference inits entirety.

The robotic tool 12526 includes a proximal housing 12537, a shaft 12538extending from the proximal housing 12537, and an end effector 12528extending from a distal end of the shaft 12538. The end effector 12528includes an ultrasonic blade 12530 a and an opposing clamp arm 12530 b.The robotic tool 12526 also includes an irrigation system 12536, whichis configured to provide a coolant, such as saline or cool CO₂ forexample, to the surgical site. Irrigation can be configured to cool thetissue and/or the ultrasonic blade 12530 a, for example. The irrigationsystem 12536 includes an irrigation channel 12540, which extends throughthe shaft 12538 to the proximal housing 12537. The irrigation channel12540 terminates at an irrigation port adjacent to the end effector12528.

In various instances, the irrigation channel 12540 can be coupled to ablower configured to direct fluid along the irrigation channel 12540within the shaft 12538 of the robotic tool 12526. The irrigation system12536 includes a blower 12546. The blower 12546 is housed in theproximal housing 12537 of the robotic tool 12526. The blower 12546 is aregenerative blower, which has been incorporated into a drive interface12548 of the robotic tool 12526. The drive interface 12548 includesrotary drivers 12550, which are driven by rotary outputs from motors inthe tool mounting portion of the robot, as described herein (see rotaryoutputs 12256 (FIG. 214) and rotary outputs 12824 a-12824 e (FIG. 222),for example).

A channel 12552 terminating in a fitting 12554 extends from the blower12546. The fitting 12554 is a luer fitting, however, the reader willreadily appreciate that alternative fittings are envisioned. The luerfitting can be selectively coupled to a reservoir that is configured toprovide the irrigation fluid to the blower 12546. In operation, coolantcan enter the insufflation line through the fitting 12554 and the blower12546 can draw the coolant toward the blower 12546 at the driveinterface 12548 and then blow the coolant distally along the shaft 12538of the robotic tool 12526 toward the end effector 12528. The coolant canbe expelled at or adjacent to the end effector 12528, which can cool theultrasonic blade and/or maintain insufflation of the surgical site, suchas insufflation of an abdomen, for example.

In FIG. 219, internal components of the drive interface 12548 aredepicted, however, certain components are excluded for clarity. Theirrigation channel 12540 extends through the shaft 12538 to the blower12546 in the proximal housing 12537. The blower 12546 is driven by arotary driver 12550 of the drive interface 12548. Similar to theinterface 12448 (FIG. 218), the interface 12548 includes four rotarydrivers 12550. In one example, a first rotary driver 12550 is configuredto power an articulation motion, a second rotary driver 12550 isconfigured to power a jaw closure motion, a third rotary driver 12550 isconfigured to power a shaft rotation, and a fourth rotary driver 12550is configured to power the irrigation system 12536. The reader willappreciate that alternative interface arrangements can include more thanor less than four rotary drivers 12550. Additionally, the drive motionsgenerated by the rotary drivers 12550 can vary depending on the desiredfunctionality of the robotic tool. Moreover, in certain instances, thedrive interface 12548 can include a transmission or shifter such thatthe rotary drivers 12550 can shift between multiple surgical functions,as further described herein (see transmission 12124 in FIG. 212 andtransmission assembly 12840 in FIGS. 223-228, for example). In oneinstance, the rotary driver 12550 coupled to the blower 12546 can alsoactuate a clamping motion of the end effector 12528, for example.

As described herein with respect to the pump 12446 in FIG. 218,operation of the blower 12546 in FIG. 219 can be coordinated with theapplication of energy by the robotic tool 12526. For example, the blower12546 can be turned on when energy is activated and, in certaininstances, the blower 12546 can remain on for a period of time after theenergy has been stopped. The duration of time for which the blower 12546can remain on after the energy has stopped may be fixed or may beproportional to the length of time the energy was activated, forexample. Additionally or alternatively, the power level of the blower12546 can be proportional or otherwise related to the activation levelof the robotic tool 12526. For example, a high power level cancorrespond to a first rate and a lower power level can correspond to asecond rate. In one example, the second rate can be less than the firstrate.

In one aspect, the robotic tool 12526 can also include an insufflationpump that is upstream of the regenerative blower 12546. The insufflationpump can direct a first volume of fluid into a trocar and a secondvolume of fluid into the regenerative blower 12546. The fluid providedto the trocar can be configured to insufflate the surgical site, forexample, the abdomen of a patient. The fluid provided by theregenerative blower 12546 can be configured to cool the ultrasonicblade, for example.

The robotic surgical tools 12426 and 12526 can be used in connectionwith a hub, such as the robotic hub 122 or the robotic hub 222, forexample. In one aspect, the robotic hubs can include a situationalawareness module, as described herein. The situational awareness modulecan be configured to determine and/or confirm a step in a surgicalprocedure and/or suggest a particular surgical action based oninformation received from various sources, including one or more roboticsurgical tool(s) and/or a generator module. In one instance, theactuation of a pump on a robotic surgical tool can inform thesituational awareness module that evacuation and/or irrigation have beenemployed, which can lead to a conclusion regarding a particular surgicalprocedure or group of surgical procedures. Similarly, data from thesituational awareness module can be supplied to a processor. In certaininstances, the processor can be communicatively coupled to a memory thatstores instructions executable by the processor to adjust a pumping rateof the pump based on data from the situational awareness module whichcan indicate, for example, the type of surgical procedure and/or thestep in the surgical procedure. For example, situational awareness canindicate that insufflation is necessary for at least a portion of aparticular surgical procedure. In such instances, a pump, such as theblower 12546 (FIG. 219) can be activated and/or maintained at a level tomaintain a sufficient insufflation.

In one aspect, the robotic surgical system includes a processor and amemory communicatively coupled to the processor, as described herein.The memory stores instructions executable by the processor to rotate adriver in a robotic tool at a variable rate to provide an adjustablepower level to a pump in the robotic tool, as described herein.

In various aspects, the present disclosure provides a control circuit torotate a rotary driver in a robotic tool at a variable rate, asdescribed herein. In various aspects, the present disclosure provides anon-transitory computer readable medium storing computer readableinstructions which, when executed, cause a machine to rotate a rotarydriver in a robotic tool at a variable rate to provide an adjustablepower level to a pump in the robotic tool, as described herein.

Referring now to FIGS. 234 and 235, a surgical procedure utilizing tworobotic tools is depicted. In FIG. 234, the robotic tools are engagedwith tissue at a surgical site. The first tool in this example is aflexible robotic retractor 12902, which is applying a retracting forceto a portion of a patient's liver L. In FIG. 235, the flexible roboticretractor 12902 can be moved along a longitudinal axis of the tool shaftin a direction A and/or can be moved laterally (e.g. pivoted at a jointbetween two rigid linkages in the robotic retractor) in a direction B.

The second tool in this example is an articulating bipolar tool 12904,which is being clamped on tissue. For example, the articulating bipolartool 12904 can be configured to mobilize liver attachments A to theliver utilizing bipolar RF currents. The articulating bipolar tool 12904can be articulated laterally (e.g. pivoted at an articulation jointproximal to the bipolar jaws of the robotic tool 12904) in the directionC. The directions A, B, and C are indicated with arrows in FIG. 235.

In the depicted example, the flexible robotic retractor 12902 seeks tohold back an organ, the liver L, as the bipolar jaws of the articulatingbipolar tool 12904 seek to cut and/or seal clamped tissue to mobilizethe liver attachments A. In one aspect, movement of the liver L by theflexible robotic retractor 12902 can be configured to maintain aconstant retraction force as the bipolar tool 12904 mobilizes the liverattachments A to the liver L. A load control algorithm can be configuredto maintain the constant retraction force on the tissue. In certaininstances, the load control algorithm can be an articulation controlalgorithm that provides a set, or predetermined, torque at thearticulation joint(s) of the articulating bipolar tool 12904 and/or theflexible robotic retractor 12902. The set torque at an articulationjoint can be approximated based on current supplied to the articulationmotor, for example.

In certain instances, the flexible robotic retractor 12902 can risk orotherwise threaten over-retraction of the liver L. For example, ifdisplacement of the flexible robotic retractor 12902 approaches a setdisplacement limit, the flexible robot retractor 12902 can risk tearinga portion of the tissue. To prevent such an over-retraction, as thedisplacement of the flexible robotic retractor 12902 approaches thedisplacement limit, the force generated by the flexible roboticretractor 12902 can be reduced by the load control algorithm. Forexample, the force can be reduced below a constant, or substantiallyconstant, retraction force when a displacement limit has been met.

Referring now to a graphical display 12910 in FIG. 236, the retractionforce F exerted on an organ and the displacement δ of the robotic tool,and by extension the organ, is plotted over time. The reader willappreciate that the robotic tools 12902 and 12904, as depicted in thesurgical procedure of FIGS. 234 and 235, can be utilized to generate thegraphical display 12910. Alternative surgical tool(s) and surgicalprocedures are also contemplated. In one aspect, an operator can set aretraction force threshold Y and a displacement limit X as depicted inFIG. 236. In other instances, the retraction force threshold Y and/orthe displacement limit X can be determined and/or computed based oninformation from a surgical hub and/or cloud. In certain instances, aparticular retraction force threshold Y and/or displacement limit X canbe recommended to a clinician based on data stored in the memory of therobot, the surgical hub, and/or the cloud. The retraction forcethreshold Y and/or the displacement limit X can depend on patientinformation, for example.

During the surgical procedure, if the retraction force F drops below theconstant retraction force threshold Y, or drops by a predefinedpercentage or amount relative to the constant retraction force thresholdY, as at times t₁, t₂, and t₃, the flexible robotic retractor 12902 canbe further displaced, to displace the organ, and increase the retractionforce F toward the threshold Y. Similarly, if the displacement δapproaches the displacement limit X, as at time t₄, the retraction forcecan be reduced to limit further displacement beyond the displacementlimit X. For example, referring again to FIG. 234, the liver L isdepicted in a second position indicated as L′. The position of the liverL′ can correspond to the displacement limit X of the flexible roboticretractor 12902.

Referring now to FIG. 237, a flow chart depicting logic steps foroperating a robotic tool, such as the tool 12902 (FIGS. 234 and 235) forexample, is depicted. A processor for the robot (e.g. the robot 12022)and/or of a processor of a hub (e.g. the hub 106, the hub 206, therobotic hub 122, and the robotic hub 222) that is in signalcommunication with the robot can set a displacement limit at step 12920.Additionally, the processor can set a force limit at step 12922. Thedisplacement limit and the force limit can be selected based on inputfrom one or more sources including a clinician input 12930, a robotinput 12932, a hub input 12934, and/or a cloud input 12936, as furtherdescribed herein. In certain instances, the hub can suggest a particularlimit based on data collected by a robot, provided to the hub, and/orstored in the cloud. For example, a situational awareness module cansuggest a particular limit based on the surgical procedure or stepthereof ascertained by the situational awareness module. Additionally oralternatively, the clinician can provide an input and/or select thelimit from the hub's suggestions. In other instances, the clinician canoverride the hub's suggestions. The limits can correspond to a range ofvalues, such as the limit ±one percent, ±five percent, or ±ten percent,for example.

The robotic tool can initially operate in a constant force mode. At step12924 in the constant force mode, the force exerted by the robotic toolcan be maintained at the force limit. The processor can monitor theforce to ensure the force stays below the force limit Y. If the forceexceeds the force limit Y, the displacement value can be increased atstep 12926 until the force reaches or sufficiently approaches the forcelimit Y. A force can sufficiently approach the force limit when theforce is within a range of values corresponding to the force limit. Theprocessor can monitor the displacement to ensure the displacement staysbelow the displacement limit X.

If the displacement approaches the displacement limit X (or enters therange of values corresponding to the displacement limit), the robotictool can switch to a displacement limit mode. In the displacement limitmode, the force value can be decreased at step 12928 to ensure therobotic tool stays within the displacement limit. A new force limit canbe set at step 12922 to ensure the displacement stays within thedisplacement limit. In such instances, the robotic tool can switch backto the constant force mode (with the new, reduced force limit) and steps12924, 12926, and 12928 can be repeated.

In certain instances, the stiffness of the shaft of one or more of therobotic tools can be factored into the load control algorithm in orderto achieve the desired amount of lateral force on an organ, like theliver L. For example, the flexible robotic retractor 12902 can define astiffness that affects the lateral load exerted on a tissue by the endeffector thereof.

In certain instances, a drive housing for a robotic tool can include aplurality of rotary drivers, which can be operably driven by one or moremotors. The motors can be positioned in a motor carriage, which can belocated at the distal end of a robotic arm. In other instances, themotors can be incorporated into the robotic tool. In certain instances,a motor can operably drive multiple rotary drivers and a transmissioncan be configured to switch between the multiple rotary drivers. In suchinstances, the robotic tool cannot simultaneously actuate two or morerotary drivers that are associated with the single drive motor. Forexample, as described herein with respect to FIG. 212, the motor 12112can selectively power one of the roll DOF 12132, the high force grip DOF12136, or the tool actuation DOF 12138. The transmission 12124 canselectively couple the motor 12112 to the appropriate DOF.

In certain instances, it can be desirable to increase the torquedelivered to an output of the robotic tool. For example, clamping and/orfiring of a surgical stapler may benefit from additional torque incertain instances, such as when the tissue to be cut and/or stapled isparticularly thick or tough. Especially for longer end effectors and/orlonger firing strokes, additional torque can be required to complete thefiring stroke. In certain instances, an I-beam firing structure can beutilized, especially for longer end effectors and/or longer firingstrokes. The I-beam can limit deflection at the distal tip of the firingstroke for example. However, an I-beam can require increased torque.

Additionally, certain robotic tools may require additional flexibilityregarding the simultaneous operation of multiple DOFs or surgical endeffector functions. To increase the power, torque, and flexibility of arobotic system, additional motors and/or larger motors can beincorporated into the motor carriage. However, the addition of motorsand/or utilization of larger motors can increase the size of the motorcarriage and the drive housing.

In certain instances, a robotic surgical tool can include a compactdrive housing. A compact drive housing can improve the access envelopeof the robotic arm. Moreover, a compact drive housing can minimize therisk of arm collisions and entanglements. Though the drive housing iscompact, it can still provide sufficient power, torque, and flexibilityto the robotic tool.

In certain instances, shifting between end effector functions can beachieved with one of the drive shafts. Shifting and locking of therotary drives may only occur when a robotic surgical system is in a restmode, for example. In one aspect, it can be practical to have threerotary drives operate as many end effector functions as needed based onthe cam structure of the shifting drive. In one aspect, by using threerotary drives in cooperation, a robotic surgical tool can shift betweenfour different possible functions instead of three different functions.For example, three rotary drives can affect shaft rotation, independenthead rotation, firing, closing, and a secondary closing means. In stillother instances, a rotary drive can selectively power a pump, such as inthe surgical tools 12426 and 12526 in FIGS. 218 and 219, respectively,for example.

Additionally or alternatively, multiple rotary drives can cooperativelydrive a single output shaft in certain instances. For example, toincrease the torque delivered to a surgical tool, multiple motors can beconfigured to deliver torque to the same output shaft at a given time.For example, in certain instances, two drive motors can drive a singleoutput. A shifter drive can be configured to independently engage anddisengage the two drive motors from the single output. In suchinstances, increased torque can be delivered to the output by a compactdrive housing that is associated with multiple rotary drivers and endeffector functions. As a result, load capabilities of the surgical toolcan be increased. Moreover, the drive housing can accommodate surgicaltools that require different surgical functions, including the operationof multiple DOFs or surgical functions.

Referring now to FIGS. 221-228, a drive system 12800 for a roboticsurgical tool 12830 is depicted. The drive system 12800 includes ahousing 12832 and a motor carriage 12828. A shaft 12834 of the surgicaltool 12830 extends from the housing 12832. The motor carriage 12828houses five motors 12826 similar to the motor carriage 12108 (FIG. 212).In other instances, the motor carriage 12828 can house less than fivemotors or more than five motors. In other instances, the motors 12826can be housed in the robotic surgical tool 12830.

Each motor 12826 is coupled to a rotary output 12824 and each rotaryoutput 12824 is coupled to a rotary input 12836 in the housing 12832 ata drive interface 12822. The rotary motions from the motors 12826 andcorresponding rotary outputs 12824 are transferred to a respectiverotary input 12836. The rotary inputs 12836 correspond to rotarydrivers, or rotary drive shafts, in the housing 12832. In one example, afirst motor 12826 a can be a left/right articulation (or yaw) motor, asecond motor 12826 b can be an up/down articulation (or pitch) motor, athird motor 12826 c can be a shifter motor, a fourth motor 12826 d canbe a first cooperative motor, and a fifth motor 12826 e can be a secondcooperative motor. Similarly, a first rotary output 12824 a can be aleft/right articulation (or yaw) output, a second rotary output 12824 bcan be an up/down articulation (or pitch) output, a third rotary output12824 c can be a shifter output, a fourth rotary output 12824 d can be afirst cooperative output, and a fifth rotary output 12824 e can be asecond cooperative output. Furthermore, a first rotary input 12836 a canbe a left/right articulation (or yaw) drive shaft, a second rotary input12836 b can be an up/down articulation (or pitch) drive shaft, a thirdrotary input 12836 c can be a shifter drive shaft, a fourth rotary input12836 d can be a first cooperative drive shaft, and a fifth rotary input12836 e can be a second cooperative drive shaft. In other instances, thedrive shafts 12836 a-12836 e can be operably positionable in differentorientations to effectuate different gear trains configurations totransmit a desired rotary output.

The surgical tool 12830 is depicted in a plurality of differentconfigurations in FIGS. 230-233. For example, the surgical tool 12830 isin an unactuated configuration in FIG. 230. The shaft 12834 has beenarticulated about the yaw and pitch axes (in the directions of thearrows A and B) in FIG. 231. Rotation of the first and second rotaryinputs 12836 a and 12836 b is configured to articulate the shaft 12834about the yaw and pitch axes, respectively. In FIG. 232, the shaft 12834has been rotated in the direction of the arrow C about the longitudinalaxis of the shaft 12834 and a jaw of the end effector 12835 has beenclosed with a low-force actuation in the direction of arrow D. Rotationof the fourth rotary output 12836 d is configured to selectively affectthe rotation of the shaft 12834, and rotation of the fifth rotary output12836 e is configured to selectively affect the low-force closure of theend effector 12835. In FIG. 233, the jaw of the end effector 12835 hasbeen clamped with a high-force actuation in the direction of arrow E,and the firing member has been advanced in the direction of arrow F.Rotation of the fourth rotary output 12836 d and the fifth rotary output12836 e is configured to selectively and cooperatively affect thehigh-force closure of the end effector 12835 and the firing of thefiring member therein, respectively.

Referring primarily now to FIGS. 223-228, the housing 12832 includesmultiple layers of gear train assemblies. Specifically, the housing12832 includes a first gear train assembly 12838 a layered under asecond gear train assembly 12838 b, which is layered under a third geartrain assembly 12838 c, which is layered under a fourth gear trainassembly 12838 d. The first gear train assembly 12838 a corresponds to afirst DOF, such as rotation of the shaft 12834, for example. The secondgear train assembly 12838 b corresponds to a second DOF, such as closure(i.e. fast closure) of the end effector 12835 with a low closure force,for example. The third gear train assembly 12838 c corresponds to athird DOF, such as clamping (i.e. slow closure) of the end effector12835 with a high closure force, for example. The fourth gear trainassembly 12838 d corresponds to a fourth DOF, such as firing of a firingelement in the end effector 12835, for example. The five rotary inputs12836 a-12836 e extend through the four layers of gear train assemblies12838 a-12838 d.

The first motor 12826 a is drivingly coupled to the first rotary input12836 a. In such instances, the first motor 12826 a is singularlyconfigured to drive the first rotary input 12836 a, which affects thefirst DOF. For example, referring primarily to FIG. 224, articulationwires 12842 can extend from the first rotary input 12836 a through theshaft 12834 of the robotic tool 12830 toward the end effector 12835.Rotation of the first rotary input 12836 a is configured to actuate thearticulation wires 12842 to affect left/right articulation of the endeffector 12835. Similarly, the second motor 12826 b is drivingly coupledto the second rotary input 12836 b. In such instances, the second motor12826 b is singularly configured to drive the second rotary input 12836b, which affects the second DOF. Referring still to FIG. 224,articulation wires 12844 can extend from the second rotary input 12836 bthrough the shaft 12834 of the robotic tool 12830 toward the endeffector 12835. Rotation of the second rotary input 12836 b isconfigured to actuate the articulation wires 12844 to affect up/downarticulation of the end effector 12835. In other instances, at least oneof the first rotary input 12836 a and the second rotary input 12836 bcan correspond to a different DOF or different surgical function.

The housing 12832 also includes a transmission assembly 12840. Forexample, the third rotary input 12836 c is a shifter drive shaft of thetransmission assembly 12840. As depicted in FIGS. 223-228, the thirdrotary input 12836 c can be a camshaft, including a plurality of camminglobes. An arrangement of cam lobes 12839 can correspond with each geartrain assembly 12838 a-12838 d layered in the housing 12832. Moreover,each gear train assembly 12838 a-12838 d includes a respective shuttle12846 a-12846 d operably engaged by the third rotary input 12836 c. Forexample, the third rotary input 12836 c can extend through an opening ineach shuttle 12846 a-12846 d and selectively engage at least oneprotrusion 12848 on the shuttle 12846 a-12846 d to affect shifting ofthe respective shuttle 12846 a-12846 d relative to the third rotaryinput 12836 c. In other words, rotation of the third rotary input 12836c is configured to affect shifting of the shuttles 12846 a-12846 d. Asthe shuttles 12846 a-12846 d shift within each gear train assembly 12838a-12838 d, respectively, the cooperative drive shafts 12836 d and 12836e are selectively drivingly coupled to one or more output shafts of therobotic tool 12830, as further described herein.

In other instances, a drive system for a robotic tool can include avertically shifting gear selector, which can be configured to shift theshuttles 12846 a-12846 d or otherwise engage an output drive from amotor to one or more input drives on the robotic tool 12830.

Referring still to FIGS. 221-228, the fourth and fifth output drives, orthe first and second cooperative drive shafts, 12836 d and 12836 e,respectively, can operate independently or in a coordinated,synchronized manner. For example, in certain instances, each cooperativedrive shaft 12836 d and 12836 e can be paired with a single output gearor output shaft. In other instances, both cooperative drives 12836 d and12836 e can be paired with a single output gear or output shaft.

Referring primarily to FIG. 225, in a first configuration of thetransmission arrangement 12840, the first cooperative drive shaft 12836d is drivingly engaged with a first output gear 12852 of the first geartrain assembly 12838 a. For example, the first gear train assembly 12838a includes one or more first idler gears 12850 a. In FIG. 225, the firstgear train assembly 12838 a includes two first idler gears 12850 a. Thefirst idler gears 12850 a are positioned on the first shuttle 12846 a inthe first gear train assembly 12838 a. In the first configuration (FIG.225), the first shuttle 12846 a has been shifted toward the first outputgear 12852 by the camshaft 12836 c such that one of the first idlergears 12850 a on the first shuttle 12846 a is moved into meshingengagement with the first output gear 12852 and one of the first idlergears 12850 a is moved into meshing engagement with the firstcooperative drive shaft 12836 d. In other words, the first cooperativedrive shaft 12836 d is drivingly engaged with the first output gear12852.

Rotation of the first output gear 12852 corresponds to a particular DOF.For example, rotation of the first output gear 12852 is configured torotate the shaft 12834 of the robotic tool 12830. In other words, in thefirst configuration of the transmission arrangement 12840 (FIG. 225), arotation of the fourth motor 12826 d and the fourth rotary output 12824d is configured to rotate the first cooperative drive shaft 12836 d,which is coupled to the first output gear 12852 via the first idlersgears 12850 a and rotates (or rolls) the shaft 12834.

The first gear train assembly 12838 a also includes a first locking arm12860 a. The first locking arm 12860 a extends from the first shuttle12846 a. Movement of the first shuttle 12846 a is configured to move thefirst locking arm 12860 a. For example, in the first configuration ofFIG. 225, the first locking arm 12860 a is disengaged from the firstgear train assembly 12838 a such that the first output gear 12852 canrotate. Movement of the first shuttle 12846 a can move the first lockingarm 12860 a into engagement with the first output gear 12852. Forexample, when the first idler gears 12850 a are moved out of engagementwith the first output gear 12852, the first locking arm 12860 a canengage the first output gear 12852 or another gear in the first geartrain assembly 12838 a to prevent the rotation of the first output gear12852.

Referring still to FIG. 225, in the first configuration of thetransmission arrangement 12840, the second cooperative drive shaft 12836e is drivingly engaged with a second output gear 12854 of the secondgear train assembly 12838 b. For example, the second gear train assembly12838 b includes one or more second idler gears 12850 b and a planetarygear 12853 that is meshingly engaged with the second output gear 12854.In FIG. 225, the second gear train assembly 12838 b includes two secondidler gears 12850 b. The second idler gears 12850 b are positioned onthe second shuttle 12846 b in the second gear train assembly 12838 b. Inthe first configuration, the second shuttle 12846 b has been shiftedtoward the second output gear 12854 by the camshaft 12836 c such thatone of the second idler gears 12850 b on the second shuttle 12846 b ismoved into meshing engagement with the planetary gear 12853, and one ofthe second idler gears 12850 b is moved into meshing engagement with thesecond cooperative drive shaft 12836 e. In other words, the secondcooperative drive shaft 12836 e is drivingly engaged with the secondoutput gear 12854 via the second idler gears 12850 b and the planetarygear 12853. The second output gear 12854 is configured to drive a secondoutput shaft 12864 (FIGS. 226-228), which transfers a drive motion tothe end effector 12835.

Rotation of the second output gear 12854 corresponds to a particularDOF. For example, a rotation of the second output gear 12854 isconfigured to close the end effector 12835 of the robotic tool 12830with a low closure force. In other words, in the first configuration ofthe transmission arrangement 12840, a rotation of the fifth motor 12826e and the fifth rotary output 12824 e is configured to rotate the secondcooperative drive shaft 12836 e, which is coupled to the second outputgear 12854, via the second idlers gears 12850 b and the planetary gear12853, and closes the end effector 12835 of the robotic tool 12830 witha low closure force.

The second gear train assembly 12838 b also includes a second lockingarm 12860 b. The second locking arm 12860 b extends from the secondshuttle 12846 b. Movement of the second shuttle 12846 b is configured tomove the second locking arm 12860 b. For example, in the firstconfiguration of FIG. 225, the second locking arm 12860 b is disengagedfrom the planetary gear 12853. Movement of the second shuttle 12846 bcan move the second locking arm 12860 b into engagement with the secondplanetary gear 12853. For example, when the second idler gears 12850 bare moved out of engagement with the second gear train assembly 12838 bor planetary gear 12853 thereof, the second locking arm 12860 b canengage a portion of the second gear train assembly 12838 b, such asplanetary gear 12853, for example, to prevent rotation of the planetarygear 12853 and the second output gear 12854.

In the first configuration, rotary drive motions can be concurrentlyapplied to the first and second cooperative drive shafts 12836 d and12836 e, respectively, to concurrently affect multiple degrees offreedom. For example, the transmission arrangement 12840 can permit thesimultaneous rotation of the shaft 12834 and closing of the end effectorjaws. In other instances, one of the output gears 12852, 12854 can belocked by the respective locking arm when the other output gear 12852,12854 is drivingly coupled to the respective cooperative drive shaft12836 d, 12836 e.

Referring still to FIG. 225, in the first configuration of thetransmission arrangement 12840, a third output gear 12856 in the thirdgear train assembly 12838 c and a fourth output gear 12858 in the fourthgear train assembly 12838 d are locked via the locking arms 12860 c and12860 d, respectively. As a result, rotation of the third output gear12856, which corresponds to clamping or high-force closing of the endeffector jaws, is prevented by the first configuration. Additionally,rotation of the fourth output gear 12858, which corresponds to firingthe firing member in the end effector 12835, is also prevented. In otherwords, when the transmission arrangement 12840 is configured to deliverrotary motions to affect a low-force closure DOF or shaft rotation DOF,high-force clamping and firing is prevented. In such instances, thehigh-force clamping function and firing function can be selectivelylocked out by the transmission arrangement 12840.

Referring now to FIG. 226, a second configuration of the transmissionarrangement 12840 is depicted. In the second configuration, the firstand second cooperative drive shafts 12836 d and 12836 e are drivinglyengaged with a third output gear 12856 of the third gear train assembly12838 c. The third output gear 12856 is configured to drive a thirdoutput shaft 12866 (FIGS. 226-228), which transfers a drive motion tothe end effector 12835. For example, the third gear train assembly 12838c includes one or more third idler gears 12850 c and a planetary gear12855 that is meshingly engaged with the third output gear 12856. InFIG. 226, the third gear train assembly 12838 c includes three thirdidler gears 12850 c. The third idler gears 12850 c are positioned on thethird shuttle 12846 c in the third gear train assembly 12838 c. In thesecond configuration, the third shuttle 12846 c has been shifted towardthe third output gear 12856 by the camshaft 12836 c such that one of thethird idler gears 12850 c is moved into meshing engagement with theplanetary gear 12855, one of the third idler gears 12850 c is moved intomeshing engagement with the first cooperative drive shaft 12836 d, andone of the third idler gears 12850 c is moved into meshing engagementwith the second cooperative drive shaft 12836 e. In other words, bothcooperative drive shafts 12836 d and 12836 e are drivingly engaged withthe third output gear 12856 via the third idler gears 12850 c and theplanetary gear 12855.

Rotation of the third output gear 12856 corresponds to a particular DOF.For example, a rotation of the third output gear 12856 is configured toclamp the end effector 12835 of the robotic tool 12830 with a highclosure force. In other words, in the second configuration of thetransmission arrangement 12840, a rotation of the fourth motor 12826 dand the fifth motor 12826 e and the corresponding rotation of the fourthrotary output 12824 d and the fifth rotary output 12824 e are configuredto rotate the cooperative drive shafts 12836 d and 12836 e,respectively. In such instances, a torque supplied by both cooperativedrive shafts 12836 d and 12836 e is coupled to the third output gear12856 via the third idlers gears 12850 c to clamp the end effector 12835of the robotic tool 12830 with a high closure force.

Referring still to FIG. 226, in the second configuration of thetransmission arrangement 12840, the third output gear 12856 is unlocked.More specifically, the third locking arm 12860 c is disengaged from thethird gear train assembly 12838 c such that the third output gear 12856can rotate. Additionally, the camshaft 12836 c has moved the firstlocking arm 12860 a into engagement with the first gear train assembly12838 a, the second locking arm 12860 b into engagement with the secondgear train assembly 12838 b, and the fourth locking arm 12860 d intoengagement with the fourth gear train assembly 12838 d to preventrotation of the first output gear 12852, the second output gear 12854,and the fourth output gear 12858, respectively. As a result, rotation ofthe shaft 12834, low-force closing of the end effector jaws, and firingof the end effector 12835, is prevented by the transmission arrangement12840 in the second configuration. In such instances, the shaft rotationfunction, the low-force closing function, and the firing function can beselectively locked out by the transmission arrangement 12840.

Referring now to FIG. 227, a third configuration of the transmissionarrangement 12840 is depicted. In the third configuration, the first andsecond cooperative drive shafts 12836 d and 12836 e are drivinglyengaged with a fourth output gear 12858 of the fourth gear trainassembly 12838 d. For example, the fourth gear train assembly 12838 dincludes one or more fourth idler gears 12850 d and a planetary gear12857 that is meshingly engaged with the fourth output gear 12858. InFIG. 227, the fourth gear train assembly 12838 d includes three fourthidler gears 12850 d. The fourth idler gears 12850 d are positioned onthe fourth shuttle 12846 d in the fourth gear train assembly 12838 d. Inthe third configuration, the fourth shuttle 12846 d has been shiftedtoward the fourth output gear 12858 by the camshaft 12836 c such thatone of the fourth idler gears 12850 d is moved into meshing engagementwith the planetary gear 12857, one of the fourth idler gears 12850 d ismoved into meshing engagement with the first cooperative drive shaft12836 d, and one of the fourth idler gears 12850 d is moved into meshingengagement with the second cooperative drive shaft 12836 e. In otherwords, both cooperative drive shafts 12836 e and 12836 e are drivinglyengaged with the fourth output gear 12858 via the fourth idler gears12850 d and the planetary gear 12857. The fourth output gear 12858 isconfigured to drive a third output shaft 12868 (FIGS. 226-228), whichtransfers a drive motion to the end effector 12835.

Rotation of the fourth output gear 12858 corresponds to a particularDOF. For example, a rotation of the fourth output gear 12858 isconfigured to firing a firing member in the end effector 12835 of therobotic tool 12830. In other words, in the third configuration of thetransmission arrangement 12840, a rotation of the fourth motor 12826 dand the fifth motor 12826 e and the corresponding rotation of the fourthrotary output 12824 d and the fifth rotary output 12824 e are configuredto rotate the cooperative drive shafts 12836 d and 12836 e,respectively. In such instances, a torque supplied by both cooperativedrive shafts 12836 d and 12836 e is coupled to the fourth output gear12858 via the fourth idlers gears 12850 d and planetary gear 12857 tofire the end effector 12835 of the robotic tool 12830.

Referring still to FIG. 227, in the third configuration of thetransmission arrangement 12840, the fourth output gear 12858 isunlocked. More specifically, the fourth locking arm 12860 d isdisengaged from the fourth gear train assembly 12838 d such that thefourth output gear 12858 can rotate. Additionally, the camshaft 12836 chas moved the first locking arm 12860 a into engagement with the firstgear train assembly 12838 a, the second locking arm 12860 b intoengagement with the second gear train assembly 12838 b, and the thirdlocking arm 12860 c into engagement with the third gear train assembly12838 c to prevent rotation of the first output gear 12852, the secondoutput gear 12854, and the third output gear 12856, respectively. As aresult, rotation of the shaft 12852, low-force closing of the endeffector jaws, and high-force clamping of the end effector jaws isprevented by the transmission arrangement 12840 in the thirdconfiguration. In such instances, the shaft rotation function, thelow-force closing function, and the high-force clamping function can beselectively locked out by the transmission arrangement 12840.

In one aspect, the dual drive motors 12826 d and 12826 e can coordinatewith the shifting motor 12826 c to provide a compact drive housing 12832that enables multiple end effector functions. Moreover, a greater torquecan be supplied for one or more end effector functions via thecooperative drive shafts 12836 d and 12836 e.

In one aspect, when the cooperative drive shafts 12836 d and 12836 e areoperated together, the two drives shafts 12836 d and 12836 e aresynchronized. For example, the drive shafts 12836 d and 12836 e can bothdrive a common output shaft such as the output shafts 12866 and/or12868. Torque can be provided to the common output shafts 12866 and/or12868 via both drive shafts 12836 d and 12836 e.

Referring now to FIG. 229, a graphical display 12890 of output torquefor different surgical functions of a robotic tool, such as the robotictool 12830 (FIGS. 221-228), for example, is depicted. The output torquefor rotating the tool shaft (e.g. shaft 12834) via a first cooperativedrive shaft and for low-force closing of end effector jaws via a secondcooperative drive shaft are less than t1, the maximum output torque froma single shaft. The lower output torques for shaft rotation andlow-force jaw closure can be within the range of loads obtainable from acable on a spindle, for example. In certain instances, other lower loadfunctionalities of the surgical tool can be affected with the outputfrom a single shaft.

To affect high-force clamping, the torque approaches t2, the maximumoutput torque from the cooperative drive shafts (e.g. cooperative driveshafts 12836 d and 12836 e). For example, t2 can be twice the value oft1. The values “a” and “b” in FIG. 229 show relative forces for therobotic tool. The value “a” is the load difference between a low-forceclosure and high-force clamping, such as closure with a closure tubesystem and clamping via an I-beam, example. In certain instances, aclosure tube system and an I-beam system can cooperate, or overlaptemporally as shown in FIG. 229, to complete the clamping of the endeffector. The value “b” can be equal to or less than the value “a”. Forexample, the torque required to fire the end effector can be the same,or substantially the same, as the difference in torque between low-forceclosing and high-force clamping. The values “a” and “b” are more thanthe maximum output torque from a single shaft, but less than the maximumoutput torque from cooperative drive shafts.

In one instance, the synchronization of multiple drive shafts (e.g.cooperative drive shafts 12836 d and 12836 e) can be the slaving of onedrive shaft to the following of the other drive shaft. For example, adifferent maximum torque threshold can be set on the slaved drive shaftsuch that it can push up to the first drive shaft's limit but not overit. In one aspect, the speed of the output shaft can be monitored forincreases and/or decreases in rotational speed. For example, a sensorcan be positioned to detect the rotational speed of the output shaft.Further, the cooperative drive shafts can be coordinated to balance thetorque when one of the cooperative drive shafts begins to slow down orbrake the output shaft instead of both cooperative drive shaftsaccelerating it.

The motors described herein are housed in a tool mount on a robotic arm.In other instances, one or more of the motors can be housed in therobotic tool.

In one aspect, input drivers at an interface of the robotic tool areconfigured to mechanically and electrically couple with output driversin a tool mount. As described herein, motors in the tool mount can beconfigured to deliver rotary drive motions to the drivers in the robotictool. In other instances, the drivers in the robotic tool can beconfigured to receive linear drive motions from output drivers in thetool mount. For example, one or more linear drive motions can betransferred across the interface between the tool mount and the robotictool.

When a single motor is drivingly coupled to an output shaft, thetransmission assembly is in a low-torque operating state in comparisonto a high-torque operating state in which more than one motor isdrivingly coupled to the output shaft. The maximum torque deliverable tothe output shaft in the high-torque operating state is greater than themaximum torque deliverable to the output shaft in the low-torqueoperating state. In one instance, the maximum torque in the high-torqueoperating state can be double the maximum torque in the low-torqueoperating state. The maximum torques deliverable to the output shaft canbe based on the size and torque capabilities of the motors.

In one aspect, the robotic surgical system includes a processor and amemory communicatively coupled to the processor, as described herein.The memory stores instructions executable by the processor toselectively operably couple a first rotary driver and a second rotarydriver to output shafts of a tool housing, wherein one of the firstrotary driver and the second rotary driver is configured to supplytorque to an output shaft in a low-torque operating state, and whereinthe first rotary driver and the second rotary driver are configured toconcurrently supply torque to an output shaft in the high-torqueoperating state, as described herein.

In various aspects, the present disclosure provides a control circuit toselectively operably couple a first rotary driver and/or a second rotarydriver to an output shaft as described herein. In various aspects, thepresent disclosure provides a non-transitory computer readable mediumstoring computer readable instructions which, when executed, cause amachine to selectively operably couple a first rotary driver and/or asecond rotary driver to an output shaft, as described herein.

Another robotic surgical system is depicted in FIGS. 239 and 240. Withreference to FIG. 239, the robotic surgical system 13000 includesrobotic arms 13002, 13003, a control device 13004, and a console 13005coupled to the control device 13004. As illustrated in FIG. 239, thesurgical system 13000 is configured for use on a patient 13013 lying ona patient table 13012 for performance of a minimally invasive surgicaloperation. The console 13005 includes a display device 13006 and inputdevices 13007, 13008. The display device 13006 is set up to displaythree-dimensional images, and the manual input devices 13007, 13008 areconfigured to allow a clinician to telemanipulate the robotic arms13002, 13003. Controls for a surgeon's console, such as the console13005, are further described in International Patent Publication No. WO2017/075121, filed Oct. 27, 2016, titled HAPTIC FEEDBACK FOR A ROBOTICSURGICAL SYSTEM INTERFACE, which is herein incorporated by reference inits entirety.

Each of the robotic arms 13002, 13003 is made up of a plurality ofmembers connected through joints and includes a surgical assembly 13010connected to a distal end of a corresponding robotic arm 13002, 13003.Support of multiple arms is further described in U.S. Patent ApplicationPublication No. 2017/0071693, filed Nov. 11, 2016, titled SURGICALROBOTIC ARM SUPPORT SYSTEMS AND METHODS OF USE, which is hereinincorporated by reference in its entirety. Various robotic armconfigurations are further described in International Patent PublicationNo. WO 2017/044406, filed Sep. 6, 2016, titled ROBOTIC SURGICAL CONTROLSCHEME FOR MANIPULATING ROBOTIC END EFFECTORS, which is hereinincorporated by reference in its entirety. In an exemplification, thesurgical assembly 13010 includes a surgical instrument 13020 supportingan end effector 13023. Although two robotic arms 13002, 13003, aredepicted, the surgical system 13000 may include a single robotic arm ormore than two robotic arms 13002, 13003. Additional robotic arms arelikewise connected to the control device 13004 and are telemanipulatablevia the console 13005. Accordingly, one or more additional surgicalassemblies 13010 and/or surgical instruments 13020 may also be attachedto the additional robotic arm(s).

The robotic arms 13002, 13003 may be driven by electric drives that areconnected to the control device 13004. According to an exemplification,the control device 13004 is configured to activate drives, for example,via a computer program, such that the robotic arms 13002, 13003 and thesurgical assemblies 13010 and/or surgical instruments 13020corresponding to the robotic arms 13002, 13003, execute a desiredmovement received through the manual input devices 13007, 13008. Thecontrol device 13004 may also be configured to regulate movement of therobotic arms 13002, 13003 and/or of the drives.

The control device 13004 may control a plurality of motors (for example,Motor 1 . . . n) with each motor configured to drive a pushing or apulling of one or more cables, such as cables coupled to the endeffector 13023 of the surgical instrument 13020. In use, as these cablesare pushed and/or pulled, the one or more cables affect operation and/ormovement of the end effector 13023. The control device 13004 coordinatesthe activation of the various motors to coordinate a pushing or apulling motion of one or more cables in order to coordinate an operationand/or movement of one or more end effectors 13023. For example,articulation of an end effector by a robotic assembly such as thesurgical assembly 13010 is further described in U.S. Patent ApplicationPublication No. 2016/0303743, filed Jun. 6, 2016, titled WRIST AND JAWASSEMBLIES FOR ROBOTIC SURGICAL SYSTEMS and in International PatentPublication No. WO 2016/144937, filed Mar. 8, 2016, titled MEASURINGHEALTH OF A CONNECTOR MEMBER OF A ROBOTIC SURGICAL SYSTEM, each of whichis herein incorporated by reference in its entirety. In anexemplification, each motor is configured to actuate a drive rod or alever arm to affect operation and/or movement of end effectors 13023 inaddition to, or instead of, one or more cables.

Driver configurations for surgical instruments, such as drivearrangements for a surgical end effector, are further described inInternational Patent Publication No. WO 2016/183054, filed May 10, 2016,titled COUPLING INSTRUMENT DRIVE UNIT AND ROBOTIC SURGICAL INSTRUMENT,International Patent Publication No. WO 2016/205266, filed Jun. 15,2016, titled ROBOTIC SURGICAL SYSTEM TORQUE TRANSDUCTION SENSING,International Patent Publication No. WO 2016/205452, filed Jun. 16,2016, titled CONTROLLING ROBOTIC SURGICAL INSTRUMENTS WITH BIDIRECTIONALCOUPLING, and International Patent Publication No. WO 2017/053507, filedSep. 22, 2016, titled ELASTIC SURGICAL INTERFACE FOR ROBOTIC SURGICALSYSTEMS, each of which is herein incorporated by reference in itsentirety. The modular attachment of surgical instruments to a driver isfurther described in International Patent Publication No. WO2016/209769, filed Jun. 20, 2016, titled ROBOTIC SURGICAL ASSEMBLIES,which is herein incorporated by reference in its entirety. Housingconfigurations for a surgical instrument driver and interface arefurther described in International Patent Publication No. WO2016/144998, filed Mar. 9, 2016, titled ROBOTIC SURGICAL SYSTEMS,INSTRUMENT DRIVE UNITS, AND DRIVE ASSEMBLIES, which is hereinincorporated by reference in its entirety. Various endocutter instrumentconfigurations for use with the robotic arms 13002, 13003 are furtherdescribed in International Patent Publication No. WO 2017/053358, filedSep. 21, 2016, titled SURGICAL ROBOTIC ASSEMBLIES AND INSTRUMENTADAPTERS THEREOF and International Patent Publication No. WO2017/053363, filed Sep. 21, 2016, titled ROBOTIC SURGICAL ASSEMBLIES ANDINSTRUMENT DRIVE CONNECTORS THEREOF, each of which is hereinincorporated by reference in its entirety. Bipolar instrumentconfigurations for use with the robotic arms 13002, 13003 are furtherdescribed in International Patent Publication No. WO 2017/053698, filedSep. 23, 2016, titled ROBOTIC SURGICAL ASSEMBLIES AND ELECTROMECHANICALINSTRUMENTS THEREOF, which is herein incorporated by reference in itsentirety. Reposable shaft arrangements for use with the robotic arms13002, 13003 are further described in International Patent PublicationNo. WO 2017/116793, filed Dec. 19, 2016, titled ROBOTIC SURGICAL SYSTEMSAND INSTRUMENT DRIVE ASSEMBLIES, which is herein incorporated byreference in its entirety.

The control device 13004 includes any suitable logic control circuitadapted to perform calculations and/or operate according to a set ofinstructions. The control device 13004 can be configured to communicatewith a remote system “RS,” either via a wireless (e.g., Wi-Fi,Bluetooth, LTE, etc.) and/or wired connection. The remote system “RS”can include data, instructions and/or information related to the variouscomponents, algorithms, and/or operations of system 13000. The remotesystem “RS” can include any suitable electronic service, database,platform, cloud “C” (see FIG. 239), or the like. The control device13004 may include a central processing unit operably connected tomemory. The memory may include transitory type memory (e.g., RAM) and/ornon-transitory type memory (e.g., flash media, disk media, etc.). Insome exemplifications, the memory is part of, and/or operably coupledto, the remote system “RS.”

The control device 13004 can include a plurality of inputs and outputsfor interfacing with the components of the system 13000, such as througha driver circuit. The control device 13004 can be configured to receiveinput signals and/or generate output signals to control one or more ofthe various components (e.g., one or more motors) of the system 13000.The output signals can include, and/or can be based upon, algorithmicinstructions which may be pre-programmed and/or input by a user. Thecontrol device 13004 can be configured to accept a plurality of userinputs from a user interface (e.g., switches, buttons, touch screen,etc. of operating the console 13005) which may be coupled to remotesystem “RS.”

A memory 13014 can be directly and/or indirectly coupled to the controldevice 13004 to store instructions and/or databases includingpre-operative data from living being(s) and/or anatomical atlas(es). Thememory 13014 can be part of, and/or or operatively coupled to, remotesystem “RS.”

In accordance with an exemplification, the distal end of each roboticarm 13002, 13003 is configured to releasably secure the end effector13023 (or other surgical tool) therein and may be configured to receiveany number of surgical tools or instruments, such as a trocar orretractor, for example.

A simplified functional block diagram of a system architecture 13400 ofthe robotic surgical system 13010 is depicted in FIG. 240. The systemarchitecture 13400 includes a core module 13420, a surgeon master module13430, a robotic arm module 13440, and an instrument module 13450. Thecore module 13420 serves as a central controller for the roboticsurgical system 13000 and coordinates operations of all of the othermodules 13430, 13440, 13450. For example, the core module 13420 mapscontrol devices to the arms 13002, 13003, determines current status,performs all kinematics and frame transformations, and relays resultingmovement commands. In this regard, the core module 13420 receives andanalyzes data from each of the other modules 13430, 13440, 13450 inorder to provide instructions or commands to the other modules 13430,13440, 13450 for execution within the robotic surgical system 13000.Although depicted as separate modules, one or more of the modules 13420,13430, 13440, and 13450 are a single component in otherexemplifications.

The core module 13420 includes models 13422, observers 13424, acollision manager 13426, controllers 13428, and a skeleton 13429. Themodels 13422 include units that provide abstracted representations (baseclasses) for controlled components, such as the motors (for example,Motor 1 . . . n) and/or the arms 13002, 13003. The observers 13424create state estimates based on input and output signals received fromthe other modules 13430, 13440, 13450. The collision manager 13426prevents collisions between components that have been registered withinthe system 13010. The skeleton 13429 tracks the system 13010 from akinematic and dynamics point of view. For example, the kinematics itemmay be implemented either as forward or inverse kinematics, in anexemplification. The dynamics item may be implemented as algorithms usedto model dynamics of the system's components.

The surgeon master module 13430 communicates with surgeon controldevices at the console 13005 and relays inputs received from the console13005 to the core module 13420. In accordance with an exemplification,the surgeon master module 13430 communicates button status and controldevice positions to the core module 13420 and includes a node controller13432 that includes a state/mode manager 13434, a fail-over controller13436, and a N-degree of freedom (“DOF”) actuator 13438.

The robotic arm module 13440 coordinates operation of a robotic armsubsystem, an arm cart subsystem, a set up arm, and an instrumentsubsystem in order to control movement of a corresponding arm 13002,13003. Although a single robotic arm module 13440 is included, it willbe appreciated that the robotic arm module 13440 corresponds to andcontrols a single arm. As such, additional robotic arm modules 13440 areincluded in configurations in which the system 13010 includes multiplearms 13002, 13003. The robotic arm module 13440 includes a nodecontroller 13442, a state/mode manager 13444, a fail-over controller13446, and a N-degree of freedom (“DOF”) actuator 13348.

The instrument module 13450 controls movement of an instrument and/ortool component attached to the arm 13002, 13003. The instrument module13450 is configured to correspond to and control a single instrument.Thus, in configurations in which multiple instruments are included,additional instrument modules 13450 are likewise included. In anexemplification, the instrument module 13450 obtains and communicatesdata related to the position of the end effector or jaw assembly (whichmay include the pitch and yaw angle of the jaws), the width of or theangle between the jaws, and the position of an access port. Theinstrument module 13450 has a node controller 13452, a state/modemanager 13454, a fail-over controller 13456, and a N-degree of freedom(“DOF”) actuator 13458.

The position data collected by the instrument module 13450 is used bythe core module 13420 to determine when the instrument is within thesurgical site, within a cannula, adjacent to an access port, or above anaccess port in free space. The core module 13420 can determine whetherto provide instructions to open or close the jaws of the instrumentbased on the positioning thereof. For example, when the position of theinstrument indicates that the instrument is within a cannula,instructions are provided to maintain a jaw assembly in a closedposition. When the position of the instrument indicates that theinstrument is outside of an access port, instructions are provided toopen the jaw assembly.

Additional features and operations of a robotic surgical system, such asthe surgical robot system depicted in FIGS. 239 and 240, are furtherdescribed in the following references, each of which is hereinincorporated by reference in its entirety:

-   -   U.S. Patent Application Publication No. 2016/0303743, filed Jun.        6, 2016, titled WRIST AND JAW ASSEMBLIES FOR ROBOTIC SURGICAL        SYSTEMS;    -   U.S. Patent Application Publication No. 2017/0071693, filed Nov.        11, 2016, titled SURGICAL ROBOTIC ARM SUPPORT SYSTEMS AND        METHODS OF USE;    -   International Patent Publication No. WO 2016/144937, filed Mar.        8, 2016, titled MEASURING HEALTH OF A CONNECTOR MEMBER OF A        ROBOTIC SURGICAL SYSTEM;    -   International Patent Publication No. WO 2016/144998, filed Mar.        9, 2016, titled ROBOTIC SURGICAL SYSTEMS, INSTRUMENT DRIVE        UNITS, AND DRIVE ASSEMBLIES;    -   International Patent Publication No. WO 2016/183054, filed May        10, 2016, titled COUPLING INSTRUMENT DRIVE UNIT AND ROBOTIC        SURGICAL INSTRUMENT;    -   International Patent Publication No. WO 2016/205266, filed Jun.        15, 2016, titled ROBOTIC SURGICAL SYSTEM TORQUE TRANSDUCTION        SENSING;    -   International Patent Publication No. WO 2016/205452, filed Jun.        16, 2016, titled CONTROLLING ROBOTIC SURGICAL INSTRUMENTS WITH        BIDIRECTIONAL COUPLING;    -   International Patent Publication No. WO 2016/209769, filed Jun.        20, 2016, titled ROBOTIC SURGICAL ASSEMBLIES;    -   International Patent Publication No. WO 2017/044406, filed Sep.        6, 2016, titled ROBOTIC SURGICAL CONTROL SCHEME FOR MANIPULATING        ROBOTIC END EFFECTORS;    -   International Patent Publication No. WO 2017/053358, filed Sep.        21, 2016, titled SURGICAL ROBOTIC ASSEMBLIES AND INSTRUMENT        ADAPTERS THEREOF;    -   International Patent Publication No. WO 2017/053363, filed Sep.        21, 2016, titled ROBOTIC SURGICAL ASSEMBLIES AND INSTRUMENT        DRIVE CONNECTORS THEREOF;    -   International Patent Publication No. WO 2017/053507, filed Sep.        22, 2016, titled ELASTIC SURGICAL INTERFACE FOR ROBOTIC SURGICAL        SYSTEMS;    -   International Patent Publication No. WO 2017/053698, filed Sep.        23, 2016, titled ROBOTIC SURGICAL ASSEMBLIES AND        ELECTROMECHANICAL INSTRUMENTS THEREOF;    -   International Patent Publication No. WO 2017/075121, filed Oct.        27, 2016, titled HAPTIC FEEDBACK CONTROLS FOR A ROBOTIC SURGICAL        SYSTEM INTERFACE;    -   International Patent Publication No. WO 2017/116793, filed Dec.        19, 2016, titled ROBOTIC SURGICAL SYSTEMS AND INSTRUMENT DRIVE        ASSEMBLIES.

The robotic surgical systems and features disclosed herein can beemployed with the robotic surgical system of FIGS. 239 and 240. Thereader will further appreciate that various systems and/or featuresdisclosed herein can also be employed with alternative surgical systemsincluding the computer-implemented interactive surgical system 100, thecomputer-implemented interactive surgical system 200, the roboticsurgical system 110, the robotic hub 122, the robotic hub 222, and/orthe robotic surgical system 15000, for example.

In various instances, a robotic surgical system can include a roboticcontrol tower, which can house the control unit of the system. Forexample, the control unit 13004 of the robotic surgical system 13000(FIG. 239) can be housed within a robotic control tower. The roboticcontrol tower can include a robotic hub such as the robotic hub 122(FIG. 2) or the robotic hub 222 (FIG. 9), for example. Such a robotichub can include a modular interface for coupling with one or moregenerators, such as an ultrasonic generator and/or a radio frequencygenerator, and/or one or more modules, such as an imaging module,suction module, an irrigation module, a smoke evacuation module, and/ora communication module.

A robotic hub can include a situational awareness module, which can beconfigured to synthesize data from multiple sources to determine anappropriate response to a surgical event. For example, a situationalawareness module can determine the type of surgical procedure, step inthe surgical procedure, type of tissue, and/or tissue characteristics,as further described herein. Moreover, such a module can recommend aparticular course of action or possible choices to the robotic systembased on the synthesized data. In various instances, a sensor systemencompassing a plurality of sensors distributed throughout the roboticsystem can provide data, images, and/or other information to thesituational awareness module. Such a situational awareness module can beincorporated into a control unit, such as the control unit 13004, forexample. In various instances, the situational awareness module canobtain data and/or information from a non-robotic surgical hub and/or acloud, such as the surgical hub 106 (FIG. 1), the surgical hub 206 (FIG.10), the cloud 104 (FIG. 1), and/or the cloud 204 (FIG. 9), for example.Situational awareness of a surgical system is further disclosed hereinand in U.S. Provisional Patent Application Ser. No. 62/611,341, titledINTERACTIVE SURGICAL PLATFORM, filed Dec. 28, 2017, and U.S. ProvisionalPatent Application Ser. No. 62/611,340, titled CLOUD-BASED MEDICALANALYTICS, filed Dec. 28, 2017, the disclosure of each of which isherein incorporated by reference in its entirety.

In certain instances, the activation of a surgical tool at certain timesduring a surgical procedure and/or for certain durations may causetissue trauma and/or may prolong a surgical procedure. For example, arobotic surgical system can utilize an electrosurgical tool having anenergy delivery surface that should only be energized when a thresholdcondition is met. In one example, the energy delivery surface shouldonly be activated when the energy delivery surface is in contact withthe appropriate, or targeted, tissue. As another example, a roboticsurgical system can utilize a suction element that should only beactivated when a threshold condition is met, such as when an appropriatevolume of fluid is present. Due to visibility restrictions, evolvingsituations, and the multitude of moving parts during a robotic surgicalprocedure, it can be difficult for a clinician to determine and/ormonitor certain conditions at the surgical site. For example, it can bedifficult to determine if an energy delivery surface of anelectrosurgical tool is in contact with tissue. It can also be difficultto determine if a particular suctioning pressure is sufficient for thevolume of fluid in the proximity of the suctioning port.

Moreover, a plurality of surgical devices can be used in certain roboticsurgical procedures. For example, a robotic surgical system can use oneor more surgical tools during the surgical procedure. Additionally, oneor more handheld instruments can also be used during the surgicalprocedure. One or more of the surgical devices can include a sensor. Forexample, multiple sensors can be positioned around the surgical siteand/or the operating room. A sensor system including the one or moresensors can be configured to detect one or more conditions at thesurgical site. For example, data from the sensor system can determine ifa surgical tool mounted to the surgical robot is being used and/or if afeature of the surgical tool should be activated. More specifically, asensor system can detect if an electrosurgical device is positioned inabutting contact with tissue, for example. As another example, a sensorsystem can detect if a suctioning element of a surgical tool is applyinga sufficient suctioning force to fluid at the surgical site.

When in an automatic activation mode, the robotic surgical system canautomatically activate one or more features of one or more surgicaltools based on data, images, and/or other information received from thesensor system. For example, an energy delivery surface of anelectrosurgical tool can be activated upon detecting that theelectrosurgical tool is in use (e.g. positioned in abutting contact withtissue). As another example, a suctioning element on a surgical tool canbe activated when the suction port is moved into contact with a fluid.In certain instances, the surgical tool can be adjusted based on thesensed conditions.

A robotic surgical system incorporating an automatic activation mode canautomatically provide a scenario-specific result based on detectedcondition(s) at the surgical site. The scenario-specific result can beoutcome-based, for example, and can streamline the decision-makingprocess of the clinician. In certain instances, such an automaticactivation mode can improve the efficiency and/or effectiveness of theclinician. For example, the robotic surgical system can aggregate datato compile a more complete view of the surgical site and/or the surgicalprocedure in order to determine the best possible course of action.Additionally or alternatively, in instances in which the clinician makesfewer decisions, the clinician can be better focused on other tasksand/or can process other information more effectively.

In one instance, a robotic surgical system can automatically adjust asurgical tool based on the proximity of the tool to avisually-detectable need and/or the situational awareness of the system.Referring to FIGS. 241A and 241B, an ultrasonic surgical tool for arobotic system 13050 is depicted in two different positions. In a firstposition, as depicted in FIG. 241A, the blade 13052 of an ultrasonicsurgical tool 13050 is positioned out of contact with tissue 13060. Insuch a position, a sensor on the ultrasonic surgical tool 13050 candetect a high resistance. When the resistance detected is above athreshold value, the ultrasonic blade 13052 can be de-energized.Referring now to FIG. 241B, the ultrasonic blade 13052 is depicted in asecond position in which the distal end of the blade 13052 is positionedin abutting contact with tissue 13060. In such instances, a sensor onthe ultrasonic surgical tool 13050 can detect a low resistance. When thedetected resistance is below a threshold value, the ultrasonic blade13052 can be activated such that therapeutic energy is delivered to thetissue 13060. Alternative sensor configurations are also envisioned andvarious sensors are further described herein.

Referring to FIGS. 242A and 242B, another surgical tool, a monopolarcautery pencil 13055, is depicted in two different positions. In a firstposition, as depicted in FIG. 242A, the monopolar cautery pencil 13055is positioned out of contact with tissue. In such a position, a sensoron the monopolar cautery pencil 13055 can detect a high resistance. Whenthe resistance detected is above a threshold value, the monopolarcautery pencil 13055 can be de-energized. Referring now to FIG. 242B,the monopolar cautery pencil 13055 is depicted in a second position inwhich the distal end of the monopolar cautery pencil 13055 is positionedin abutting contact with tissue. In such instances, a sensor on themonopolar cautery pencil 13055 can detect a low resistance. When thedetected resistance is below a threshold value, the monopolar cauterypencil 13055 can be activated such that therapeutic energy is deliveredto the tissue. Alternative sensor configurations are also envisioned andvarious sensors are further described herein.

FIG. 243 shows a graphical display 13070 of continuity C and current Iover time t for the ultrasonic surgical tool 13050 of FIGS. 241A and241B. Similarly, the monopolar cautery pencil 13055 can generate agraphical display similar in many respects to the graphical display13070, in certain instances. In the graphical display 13070, continuityC is represented by a dotted line, and current I is represented by asolid line. When the resistance is high and above a threshold value, thecontinuity C can also be high. The threshold value can be between 40 and400 ohms, for example. At time A′, the continuity C can decrease belowthe threshold value, which can indicate a degree of tissue contact. As aresult, the robotic surgical system can automatically activate advancedenergy treatment of the tissue. The ultrasonic transducer currentdepicted in FIG. 243 increases from time A′ to B′ when the continuityparameters indicate the degree of tissue contact. In various instances,the current I can be capped at a maximum value indicated at B′, whichcan correspond to an open jaw transducer limit, such as in instances inwhich the jaw is not clamped, as shown in FIGS. 241A and 241B. Invarious instances, the situational awareness module of the roboticsurgical system may indicate that the jaw is unclamped. Referring againto the graphical display 13070 in FIG. 243, energy is applied until timeC′, at which time a loss of tissue contact is indicated by the increasein continuity C above the threshold value. As a result, the ultrasonictransducer current I can decrease to zero as the ultrasonic blade isde-energized.

In various instances, a sensor system can be configured to detect atleast one condition at the surgical site. For example, a sensor of thesensor system can detect tissue contact by measuring continuity alongthe energy delivery surface of the ultrasonic blade. Additionally oralternatively, the sensor system can include one or more additionalsensors positioned around the surgical site. For example, one or moresurgical tools and/or instruments being used in the surgical procedurecan be configured to detect a condition at the surgical site. The sensorsystem can be in signal communication with a processor of the roboticsurgical system. For example, the robotic surgical system can include acentral control tower including a control unit housing a processor andmemory, as further described herein. The processor can issue commands tothe surgical tool based on inputs from the sensor system. In variousinstances, situational awareness can also dictate and/or influence thecommands issued by the processor.

Turning now to FIG. 244, an end effector 196400 includes RF data sensors196406, 196408 a, 196408 b located on jaw member 196402. The endeffector 196400 includes jaw member 196402 and an ultrasonic blade196404. The jaw member 196402 is shown clamping tissue 196410 locatedbetween the jaw member 196402 and the ultrasonic blade 196404. A firstsensor 196406 is located in a center portion of the jaw member 196402.Second and third sensors 196408 a, 196408 b, respectively, are locatedon lateral portions of the jaw member 196402. The sensors 196406, 196408a, 196408 b are mounted or formed integrally with a flexible circuit196412 (shown more particularly in FIG. 245) configured to be fixedlymounted to the jaw member 196402.

The end effector 196400 is an example end effector for various surgicaldevices described herein. The sensors 196406, 196408 a, 196408 b areelectrically connected to a control circuit via interface circuits. Thesensors 196406, 196408 a, 196408 b are battery powered and the signalsgenerated by the sensors 196406, 196408 a, 196408 b are provided toanalog and/or digital processing circuits of the control circuit.

In one aspect, the first sensor 196406 is a force sensor to measure anormal force F₃ applied to the tissue 196410 by the jaw member 196402.The second and third sensors 196408 a, 196408 b include one or moreelements to apply RF energy to the tissue 196410, measure tissueimpedance, down force F₁, transverse forces F₂, and temperature, amongother parameters. Electrodes 196409 a, 196409 b are electrically coupledto an energy source such as an electrical circuit and apply RF energy tothe tissue 196410. In one aspect, the first sensor 196406 and the secondand third sensors 196408 a, 196408 b are strain gauges to measure forceor force per unit area. It will be appreciated that the measurements ofthe down force F₁, the lateral forces F₂, and the normal force F₃ may bereadily converted to pressure by determining the surface area upon whichthe force sensors 196406, 196408 a, 196408 b are acting upon.Additionally, as described with particularity herein, the flexiblecircuit 196412 may include temperature sensors embedded in one or morelayers of the flexible circuit 196412. The one or more temperaturesensors may be arranged symmetrically or asymmetrically and providetissue 196410 temperature feedback to control circuits of an ultrasonicdrive circuit and an RF drive circuit.

One or more sensors such as a magnetic field sensor, a strain gauge, apressure sensor, a force sensor, an inductive sensor such as, forexample, an eddy current sensor, a resistive sensor, a capacitivesensor, an optical sensor, and/or any other suitable sensor, may beadapted and configured to measure tissue compression and/or impedance.

FIG. 245 illustrates one aspect of the flexible circuit 196412 shown inFIG. 244 in which the sensors 196406, 196408 a, 196408 b may be mountedto or formed integrally therewith. The flexible circuit 196412 isconfigured to fixedly attach to the jaw member 196402. As shownparticularly in FIG. 245, asymmetric temperature sensors 196414 a,196414 b are mounted to the flexible circuit 196412 to enable measuringthe temperature of the tissue 196410 (FIG. 244).

The reader will appreciate that alternative surgical tools can beutilized in the automatic activation mode described above with respectto FIGS. 241A-245.

FIG. 246 is a flow chart 13150 depicting an automatic activation mode13151 of a surgical tool. In various instances, the robotic surgicalsystem and processor thereof is configured to implement the processesindicated in FIG. 246. Initially, a sensor system is configured todetect a condition at step 13152. The detected condition is communicatedto a processor, which compares the detected condition to a thresholdparameter at step 13154. The threshold parameter can be a maximum value,minimum value, or range of values. If the sensed condition is anout-of-bounds condition, the processor can adjust the surgical functionat step 13156 and the processor can repeat the comparison process ofsteps 13152 and 13154. If the sensed condition is not an out-of-boundscondition, no adjustment is necessary (13158) and the comparison processof steps 13152 and 13154 can be repeated again.

In various instances, the robotic surgical system can permit a manualoverride mode 13153. For example, upon activation of the manual overrideinput 13160, such as by a clinician, the surgical system can exit theautomatic activation mode 13151 at step 13162 depicted in FIG. 246. Insuch instances, even when a sensed condition is an out-of-boundscondition, the surgical function would not be automatically adjusted bythe processor. However, in such instances, the processor can issue awarning or recommendation to the clinician recommending a particularcourse of action based on the sensed condition(s).

In various instances, an automatic activation mode can be utilized witha robotic surgical system including a suctioning feature. In oneinstance, a robotic surgical system can communicate with a suctionand/or irrigation tool. For example, a suction and/or irrigation device(see module 128 in FIG. 3) can communicate with a robotic surgicalsystem via the surgical hub 106 (FIG. 1) and/or the surgical hub 206(FIG. 9) and a suction and/or irrigation tool can be mounted to arobotic arm. The suction/irrigation device can include a distal suctionport and a sensor. In another instance, a robotic surgical tool, such asan electrosurgical tool, can include a suctioning feature and a suctionport on the end effector of the tool.

Referring to FIG. 247, when a suction port on an end effector 13210 ismoved into contact with a fluid, a processor of the robotic surgicalsystem can automatically activate the suction feature. For example, afluid detection sensor 13230 on the tool 13200 can detect fluid 13220 inthe proximity of the tool 13200 and/or contacting the tool 13200. Thefluid detection sensor 13230 can be a continuity sensor, for example.The fluid detection sensor 13230 can be in signal communication with theprocessor such that the processor is configured to receive input and/orfeedback from the fluid detection sensor 13230. In certain instances,the suctioning feature can be automatically activated when the suctionport is moved into proximity with a fluid 13220. For example, when thesuction port moves within a predefined spatial range of a fluid 13220,the suction feature can be activated by the processor. The fluid 13220can be saline, for example, which can be provided to the surgical siteto enhance conductivity and/or irrigate the tissue.

In various instances, the tool can be a smoke evacuation tool and/or caninclude a smoke evacuation system, for example. A detail view of an endeffector 13210 of a bipolar radio-frequency surgical tool 13200 is shownin FIG. 247. The end effector 13210 is shown in a clamped configuration.Moreover, smoke and steam 13220 from an RF weld accumulate around theend effector 13210. In various instances, to improve visibility andefficiency of the tool 13200, the smoke and steam 13220 at the surgicalsite can be evacuated along a smoke evacuation channel 13240 extendingproximally from the end effector. The evacuation channel 13240 canextend through the shaft 13205 of the surgical tool 13200 to theinterface of the surgical tool 13200 and the robot. The evacuationchannel 13240 can be coupled to a pump for drawing the smoke and/orsteam 13220 along the smoke evacuation channel 13240 within the shaft13205 of the surgical tool 13200. In various instances, the surgicaltool 13200 can include insufflation, cooling, and/or irrigationcapabilities, as well.

In one instance, the intensity of the suction pressure can beautomatically adjusted based on a measured parameter from one or moresurgical devices. In such instances, the suction pressure can varydepending on the sensed parameters. Suction tubing can include a sensorfor detecting the volume of fluid being extracted from the surgicalsite. When increased volumes of fluid are being extracted, the power tothe suction feature can be increased such that the suctioning pressureis increased. Similarly, when decreased volumes of fluid are beingextracted, the power to the suction feature can be decreased such thatthe suctioning pressure is decreased.

In various instances, the sensing system for a suction tool can includea pressure sensor. The pressure sensor can detect when an occlusion isobstructing, or partially obstructing, the fluid flow. The pressuresensor can also detect when the suction port is moved into abuttingcontact with tissue. In such instances, the processor can reduce and/orpause the suctioning force to release the tissue and/or clear theobstruction. In various instances, the processor can compare thedetected pressure to a threshold maximum pressure. Exceeding the maximumthreshold pressure may lead to unintentional tissue trauma from thesuctioning tool. Thus, to avoid such trauma, the processor can reduceand/or pause the suctioning force to protect the integrity of tissue inthe vicinity thereof.

A user can manually override the automatic adjustments implemented inthe automatic activation mode(s) described herein. The manual overridecan be a one-time adjustment to the surgical tool. In other instances,the manual override can be a setting that turns off the automaticactivation mode for a specific surgical action, a specific duration,and/or a global override for the entire procedure.

In one aspect, the robotic surgical system includes a processor and amemory communicatively coupled to the processor, as described herein.The processor is communicatively coupled to a sensor system, and thememory stores instructions executable by the processor to determine ause of a robotic tool based on input from the sensor system and toautomatically energize an energy delivery surface of the robotic toolwhen the use is determined, as described herein.

In various aspects, the present disclosure provides a control circuit toautomatically energize an energy delivery surface, as described herein.In various aspects, the present disclosure provides a non-transitorycomputer readable medium storing computer readable instructions which,when executed, cause a machine to automatically energize an energydelivery surface of a robotic tool, as described herein.

In one aspect, the robotic surgical system includes a processor and amemory communicatively coupled to the processor, as described herein.The processor is communicatively coupled to a fluid detection sensor,and the memory stores instructions executable by the processor toreceive input from the fluid detection sensor and to automaticallyactivate a suctioning mode when fluid is detected, as described herein.

In various aspects, the present disclosure provides a control circuit toautomatically activate a suctioning mode, as described herein. Invarious aspects, the present disclosure provides a non-transitorycomputer readable medium storing computer readable instructions which,when executed, cause a machine to automatically activate a suctioningmode, as described herein.

Multiple surgical devices, including a robotic surgical system andvarious handheld instruments, can be used by a clinician during aparticular surgical procedure. When manipulating one or more robotictools of the robotic surgical system, a clinician is often positioned ata surgeon's command console or module, which is also referred to as aremote control console. In various instances, the remote control consoleis positioned outside of a sterile field and, thus, can be remote to thesterile field and, in some instances, remote to the patient and even tothe operating room. If the clinician desires to use a handheldinstrument, the clinician may be required to step away from the remotecontrol console. At this point, the clinician may be unable to controlthe robotic tools. For example, the clinician may be unable to adjustthe position or utilize the functionality of the robotic tools. Uponstepping away from the remote control console, the clinician may alsolose sight of one or more displays on the robotic surgical system. Theseparation between the control points for the handheld instruments andthe robotic surgical system may inhibit the effectiveness with which theclinician can utilize the surgical devices, both robotic tools andsurgical instruments, together.

In various instances, an interactive secondary display is configured tobe in signal communication with the robotic surgical system. Theinteractive secondary display includes a control module in variousinstances. Moreover, the interactive secondary display is configured tobe wireless and movable around an operating room. In various instances,the interactive secondary display is positioned within a sterile field.In one instance, the interactive secondary display allows the clinicianto manipulate and control the one or more robotic tools of the roboticsurgical system without having to be physically present at the remotecontrol console. In one instance, the ability for the clinician tooperate the robotic surgical system away from the remote control consoleallows multiple devices to be used in a synchronized manner. As a safetymeasure, in certain instances, the remote control console includes anoverride function configured to prohibit control of the robotic tools bythe interactive secondary display.

FIG. 248 depicts a surgical system 13100 for use during a surgicalprocedure that utilizes a surgical instrument 13140 and a roboticsurgical system 13110. The surgical instrument 13140 is a poweredhandheld instrument. The surgical instrument 13140 can be a radiofrequency (RF) instrument, an ultrasonic instrument, a surgical stapler,and/or a combination thereof, for example. The surgical instrument 13140includes a display 13142 and a processor 13144. In certain instances,the handheld surgical instrument 13140 can be a smart or intelligentsurgical instrument having a plurality of sensors and a wirelesscommunication module.

The robotic surgical system 13110 includes a robot 13112 including atleast one robotic tool 13117 configured to perform a particular surgicalfunction. The robotic surgical system 13110 is similar in many respectsto robotic surgical system 13000 discussed herein. The robotic tool13117 is movable in a space defined by a control envelope of the roboticsurgical system 13110. In various instances, the robotic tool 13117 iscontrolled by various clinician inputs at a remote control console13116. In other words, when a clinician applies an input at the remotecontrol console 13116, the clinician is away from the patient's body andoutside of a sterile field 13138. Clinician input to the remote controlconsole 13116 is communicated to a robotic control unit 13114 thatincludes a robot display 13113 and a processor 13115. The processor13115 directs the robotic tool(s) 13117 to perform the desiredfunction(s).

In various instances, the surgical system 13100 includes a surgical hub13120, which is similar in many respects to the hub 106, the hub 206,the robotic hub 122, or the robotic hub 222, for example. The surgicalhub 13120 is configured to enhance cooperative and/or coordinated usageof the robotic surgical system 13110 and the surgical instrument(s)13140. The surgical hub 13120 is in signal communication with thecontrol unit 13114 of the robotic surgical system 13110 and theprocessor 13144 of the surgical instrument(s) 13140. In variousinstances, a signal is transmitted through a wireless connection,although any suitable connection can be used to facilitate thecommunication. The control unit 13114 of the robotic surgical system13110 is configured to send information to the surgical hub 13120regarding the robotic tool(s) 13117. Such information includes, forexample, a position of the robotic tool(s) 13117 within the surgicalsite, an operating status of the robotic tool(s) 13117, a detected forceby the robotic tool(s), and/or the type of robotic tool(s) 13117attached to the robotic surgical system 13110, although any relevantinformation and/or operating parameters can be communicated. Examples ofsurgical hubs are further described herein and in U.S. ProvisionalPatent Application Ser. No. 62/611,341, titled INTERACTIVE SURGICALPLATFORM, filed Dec. 28, 2017, the disclosure of which is hereinincorporated by reference in its entirety.

In other instances, the robotic surgical system 13110 can encompass thesurgical hub 13120 and/or the control unit 13114 can be incorporatedinto the surgical hub 13120. For example, the robotic surgical system13110 can include a robotic hub including a modular control tower thatincludes a computer system and a modular communication hub. One or moremodules can be installed in the modular control tower of the robotichub. Examples of robotic hubs are further described herein and in U.S.Provisional Patent Application Ser. No. 62/611,341, titled INTERACTIVESURGICAL PLATFORM, filed Dec. 28, 2017, the disclosure of which isherein incorporated by reference in its entirety.

The processor 13144 of the surgical instrument(s) 13140 is configured tosend information to the surgical hub 13120 regarding the surgicalinstrument 13140. Such information includes, for example, a position ofthe surgical instrument(s) 13140 within the surgical site, an operatingstatus of the surgical instrument(s) 13140, a detected force by thesurgical instrument(s) 13140, and/or identification informationregarding the surgical instrument(s) 13140, although any relevantinformation and/or operating parameters can be sent to the surgical hub.

In various instances, a hub display 13125 is in signal communicationwith the surgical hub 13120 and may be incorporated into the modularcontrol tower, for example. The hub display 13125 is configured todisplay information received from the robotic surgical system 13110 andthe surgical instrument(s) 13140. The hub display 13125 can be similarin many respects to the visualization system 108 (FIG. 1), for example.In one aspect, the hub display 13125 can include an array of displayssuch as video monitors and/or heads-up displays around the operatingroom, for example.

In various instances, the surgical hub 13120 is configured to recognizewhen the surgical instrument 13140 is activated by a clinician viawireless communication signal(s). Upon activation, the surgicalinstrument 13140 is configured to send identification information to thesurgical hub 13120. Such identification information may include, forexample, a model number of the surgical instrument, an operating statusof the surgical instrument, and/or a location of the surgicalinstrument, although other suitable device parameters can becommunicated. In various instances, the surgical hub 13120 is configuredto utilize the communicated information to assess the compatibility ofthe surgical instrument 13140 with the capabilities of the surgical hub13120. Examples of capabilities of the surgical hub with compatiblesurgical instruments are further discussed herein.

In various instances, the control unit 13114 of the robotic surgicalsystem 13110 is configured to communicate a video feed to the surgicalhub 13120, and the surgical hub 13120 is configured to communicate theinformation, or a portion thereof, to the surgical instrument 13140,which can replicate a portion of the robot display 13113, or otherinformation from the robotic surgical system 13110, on a display 13142of the surgical instrument 13140. In other instances, the roboticsurgical system 13110 (e.g. the control unit 13114 or surgical tool13117) can communicate directly with the surgical instrument 13140, suchas when the robotic surgical system 13110 includes a robotic hub and/orthe surgical tool 13117 includes a wireless communication module, forexample. The reproduction of a portion of the robot display 13113 on thesurgical instrument 13140 allows the clinician to cooperatively use bothsurgical devices by providing, for example, alignment data to achieveintegrated positioning of the surgical instrument 13140 relative to therobotic tool(s) 13117. In various instances, the clinician is able toremove any unwanted information displayed on the display 13142 of thesurgical instrument 13140.

Referring still to FIG. 248, in various instances, the surgical system13100 further includes an interactive secondary display 13130 within thesterile field 13138. The interactive secondary display 13130 is also alocal control module within the sterile field 13138. The remote controlconsole 13116, or the primary control, can be positioned outside thesterile field 13138. For example, the interactive secondary display13130 can be a handheld mobile electronic device, such as an iPad®tablet, which can be placed on a patient or the patient's table during asurgical procedure. For example, the interactive secondary display 13130can be placed on the abdomen or leg of the patient during the surgicalprocedure. In other instances, the interactive secondary display 13130can be incorporated into the surgical instrument 13140 within thesterile field 13138. In various instances, the interactive secondarydisplay 13130 is configured to be in signal communication with therobotic surgical system 13110 and/or the surgical instrument 13140. Insuch instances, the interactive secondary display 13130 is configured todisplay information received from the robotic tool(s) 13117 (forexample, robotic tool 1, robotic tool 2, . . . robotic tool n) and thesurgical instruments 13140 (for example, surgical instrument 1, surgicalinstrument 2, . . . surgical instrument n). The interactive secondarydisplay 13130 depicts tool information 13133 and instrument information13135 thereon. In various instances, the user is able to interact withthe interactive secondary display 13130 to customize the size and/orlocation of the information displayed.

Referring still to FIG. 248, in various instances, the surgical hub13120 is configured to transmit robot status information of the surgicalrobot system 13100 to the surgical instrument 13140, and the surgicalinstrument 13140 is configured to display the robot status informationon the display 13142 of the surgical instrument 13140.

In various instances, the display 13142 of the surgical instrument 13140is configured to communicate commands through the surgical hub 13120 tothe control unit 13114 of the robotic surgical system 13110. Afterviewing and interpreting the robot status information displayed on thedisplay 13142 of the surgical instrument 13140 as described herein, aclinician may want to utilize one or more functions of the roboticsurgical system 13110. Using the buttons and/or a touch-sensitivedisplay 13142 on the surgical instrument 13140, the clinician is able toinput a desired utilization of and/or adjustment to the robotic surgicalsystem 13110. The clinician input is communicated from the surgicalinstrument 13140 to the surgical hub 13120. The surgical hub 13120 isthen configured to communicate the clinician input to the control unit13114 of the robotic surgical system 13110 for implementation of thedesired function. In other instances, the handheld surgical instrument13140 can communicate directly with the control unit 13114 of therobotic surgical system 13110, such as when the robotic surgical system13110 includes a robotic hub, for example.

In various instances, the surgical hub 13120 is in signal communicationwith both the robotic surgical system 13110 and the surgical instrument13140, allowing the surgical system 13100 to adjust multiple surgicaldevices in a synchronized, coordinated, and/or cooperative manner. Theinformation communicated between the surgical hub 13120 and the varioussurgical devices includes, for example, surgical instrumentidentification information and/or the operating status of the varioussurgical devices. In various instances, the surgical hub 13120 isconfigured to detect when the surgical instrument 13140 is activated. Inone instance, the surgical instrument 13140 is an ultrasonic dissector.Upon activation of the ultrasonic dissector, the surgical hub 13120 isconfigured to communicate the received activation information to thecontrol unit 13114 of the robotic surgical system 13110.

In various instances, the surgical hub 13120 automatically communicatesthe information to the control unit 13114 of the robotic surgical system13110. The reader will appreciate that the information can becommunicated at any suitable time, rate, interval and/or schedule. Basedon the information received from the surgical hub 13120, the controlunit 13114 of the robotic surgical system 13110 is configured to decidewhether to activate at least one robotic tool 13117 and/or activate aparticular operating mode, such as a smoke evacuation mode, for example.For example, upon activation of a surgical tool that is known togenerate, or possibly generate, smoke and/or contaminants at thesurgical site, such as an ultrasonic dissector, the robotic surgicalsystem 13110 can automatically activate the smoke evacuation mode or cancue the surgeon to activate the smoke evacuation mode. In variousinstances, the surgical hub 13120 is configured to continuouslycommunicate additional information to the control unit 13114 of therobotic surgical system 13110, such as various sensed tissue conditions,in order to adjust, continue, and/or suspend further movement of therobotic tool 13117 and/or the entered operating mode.

In various instances, the surgical hub 13120 may calculate parameters,such as smoke generation intensity, for example, based on the additionalinformation communicated from the surgical instrument 13140. Uponcommunicating the calculated parameter to the control unit 13114 of therobotic surgical system 13110, the control unit 13114 is configured tomove at least one robotic tool and/or adjust the operating mode toaccount for the calculated parameter. For example, when the roboticsurgical system 13110 enters the smoke evacuation mode, the control unit13114 is configured to adjust a smoke evacuation motor speed to beproportionate to the calculated smoke generation intensity.

In certain instances, an ultrasonic tool mounted to the robot 13112 caninclude a smoke evacuation feature that can be activated by the controlunit 13114 to operate in a smoke evacuation mode. In other instances, aseparate smoke evacuation device can be utilized. For example, a smokeevacuation tool can be mounted to another robotic arm and utilizedduring the surgical procedure. In still other instances, a smokeevacuation instrument that is separate from the robotic surgical system13110 can be utilized. The surgical hub 13120 can coordinatecommunication between the robotically-controlled ultrasonic tool and thesmoke evacuation instrument, for example.

In FIGS. 249-252, various surgical devices and components thereof aredescribed with reference to a colon resection procedure. The reader willappreciate that the surgical devices, systems, and procedures describedwith respect to those figures are an exemplary application of the systemof FIG. 248. Referring now to FIG. 249, a handle portion 13202 of ahandheld surgical instrument 13300 is depicted. In certain aspects, thehandheld surgical instrument 13300 corresponds to the surgicalinstrument 13140 of the surgical system 13100 in FIG. 248. In oneinstance, the handheld surgical instrument 13300 is a powered circularstapler and includes a display 13310 on the handle portion 13302thereof.

Before pairing the handheld surgical instrument 13300 to a roboticsurgical system (e.g. the robotic surgical system 13110 in FIG. 248) viathe surgical hub 13320 (FIG. 250), as described herein, the display13310 on the handle 13302 of the handheld surgical instrument 13300 caninclude information regarding the status of the instrument 13300, suchas the clamping load 13212, the anvil status 13214, and/or theinstrument or cartridge status 13216, for example. In various instances,the display 13310 of the handheld surgical instrument 13300 includes analert 13318 to the user that communicates the status of the firingsystem. In various instances, the display 13310 is configured to displaythe information in a manner that communicates the most importantinformation to the user. For example, in various instances, the display13310 is configured to display warning information in a larger size, ina flashing manner, and/or in a different color. When the handheldsurgical instrument 13300 is not paired with a surgical hub, the display13310 can depict information gathered only from the handheld surgicalinstrument 13300 itself.

Referring now to FIG. 250, after pairing the handheld surgicalinstrument 13300 with the surgical hub 13320, as described herein withrespect to FIG. 248, for example, the information detected and displayedby the handheld surgical instrument 13300 can be communicated to thesurgical hub 13320 and displayed on a hub display (e.g. the hub display13125 of FIG. 248). Additionally or alternatively, the information canbe displayed on the display of the robotic surgical system. Additionallyor alternatively, the information can be displayed on the display 13310on the handle portion 13302 of the handheld surgical instrument 13300.In various instances, a clinician can decide what information isdisplayed at the one or multiple locations. As mentioned above, invarious instances, the clinician is able to remove any unwantedinformation displayed on the display 13310 of the handheld surgicalinstrument 13300, the display of the robotic surgical system, and/or thedisplay on the hub display.

Referring still to FIG. 250, after pairing the handheld surgicalinstrument 13300 with the robotic surgical system, the display 13310 onthe handle portion 13302 of the handheld surgical instrument 13300 canbe different than the display 13310 on the handheld surgical instrument13300 before pairing with the robotic surgical system. For example,procedural information from the surgical hub 13320 and/or roboticsurgical system can be displayed on the powered circular stapler. Forexample, as seen in FIG. 250, robot status information includingalignment information 13312 from the surgical hub 13320 and one or moreretraction tensions 13316, 13317 exerted by a robotic tool on particulartissue(s), is displayed on the display 13310 of the handheld surgicalinstrument 13300 for the convenience of the clinician. In variousinstances, the display 13310 of the handheld surgical instrument 13300includes an alert 13318 to the user that communicates a parametermonitored by the surgical hub 13320 during a surgical procedure. Invarious instances, the display 13310 is configured to display theinformation in a manner that communicates the most important informationto the user. For example, in various instances, the display 13310 isconfigured to display warning information in a larger size, in aflashing manner, and/or in a different color.

Referring still to FIG. 250, the display 13310 of the handheld surgicalinstrument 13300 is configured to display information regarding one ormore retraction tensions 13316, 13317 exerted by one or more devicesduring a surgical procedure involving one or more robotic tools. Forexample, the handheld surgical instrument 13300, the powered circularstapler, is involved a the colon resection procedure of FIG. 251. Inthis procedure, one device (e.g. a robotic tool) is configured to graspcolonic tissue and another device (e.g. the handheld circular stapler)is configured to grasp rectal tissue. As the devices move apart from oneanother, the force of retracting the colonic tissue F_(RC) and the forceof retracting the rectal tissue F_(RR) are monitored. In the illustratedexample, an alert notification 13318 is issued to the user as the forceof retracting the colonic tissue has exceeded a predetermined threshold.Predetermined thresholds for both retracting forces F_(RC), F_(RR) areindicated by horizontal dotted lines on the display 13310. The user isnotified when one or both thresholds are surpassed and/or reached in aneffort to minimize damage and/or trauma to the surrounding tissue.

In FIG. 252, graphical displays 13330, 13340 of retracting forcesF_(RC), F_(RR) are illustrated. In the circumstances illustrated in thegraphical displays 13330, 13340, the user is notified whenpre-determined thresholds are exceeded, depicted by the shaded region13332 of the graphical display 13330, indicating that the retractingforce of the colonic tissue F_(RC) has exceeded a predeterminedthreshold of 0.5 lbs.

In certain instances, it can be difficult to align the end effector of acircular stapler with targeted tissue during a colorectal procedurebecause of visibility limitations. For example, referring again to FIG.251, during a colon resection, the surgical instrument 13300, a circularstapler, can be positioned adjacent to a transected rectum 13356.Moreover, the anvil 13301 of the surgical instrument 13300 can beengaged with a transected colon 13355. A robotic tool 133175 isconfigured to engage the anvil 13301 and apply the retracting forceF_(RC). It can be difficult to confirm the relative position of thesurgical instrument 13300 with the targeted tissue, for example, withthe staple line through the transected colon 13355. In certaininstances, information from the surgical hub 13320 and robotic surgicalsystem can facilitate the alignment. For example, as shown in FIG. 250,the center of the surgical instrument 13300 can be shown relative to thecenter of the targeted tissue 13318 on the display screen 13310 of thesurgical instrument 13300. In certain instances, and as shown in FIG.251, sensors and a wireless transmitter on the surgical instrument 13300can be configured to convey positioning information to the surgical hub13320, for example.

A colorectal procedure, visibility limitations thereof, and an alignmenttool for a surgical hub are further described herein and in U.S.Provisional Patent Application Ser. No. 62/611,341, titled INTERACTIVESURGICAL PLATFORM, filed Dec. 28, 2017, the disclosure of which isherein incorporated by reference in its entirety.

As mentioned above, the display 13310 on the handheld instrument 13300can also be configured to alert the clinician in certain scenarios. Forexample, the display 13310 in FIG. 250 includes an alert 13318 becausethe one or more of the forces exceed the predefined force thresholds.Referring again to FIGS. 251 and 252, during the colon resection, therobotic arm can exert a first force F_(RC) on the anvil, and thehandheld instrument 13300 can exert a second force F_(RR) on the rectum13356. The tension on the rectum 13356 by the circular stapler can becapped at a first limit (for example 0.5 lb in FIG. 252), and thetension on the colon 13355 from the robotic arm can be capped at asecond limit (for example 0.5 lb in FIG. 252). An intervention may besuggested to the clinician when the tension on the rectum 13356 or colon13355 exceeds a threshold value.

The tension on the colon F_(RC) in FIGS. 251 and 252 can be ascertainedby resistance to the robotic arm, and thus, can be determined by acontrol unit (e.g. the control unit 13114 of the robotic surgical system13110). Such information can be communicated to the handheld surgicalinstrument 13300 and displayed on the display 13310 thereof in thesterile field such that the information is readily available to theappropriate clinician in real-time, or near real-time, or any suitableinterval, rate, and/or schedule, for example.

In various instances, a surgical system, such as a surgical system 13360of FIGS. 253 and 254, includes interactive secondary displays 13362,13364 within the sterile field. The interactive secondary displays13362, 13364 are also mobile control modules in certain instances andcan be similar to the interactive secondary displays 13130 in FIG. 248,for example. A surgeon's command console, or remote control module,13370, is the primary control module and can be positioned outside thesterile field. In one instance, the interactive secondary display 13362can be a mobile device, a watch, and/or a small tablet, which can beworn on the wrist and/or forearm of the user, and the interactivesecondary display 13364 can be a handheld mobile electronic device, suchas an iPad® tablet, which can be placed on a patient 13361 or thepatient's table during a surgical procedure. For example, theinteractive secondary displays 13362, 13364 can be placed on the abdomenor leg of the patient 13361 during the surgical procedure. In otherinstances, the interactive secondary displays 13362, 13364 can beincorporated into a handheld surgical instrument 13366 within thesterile field.

In one instance, the surgical system 13360 is shown during a surgicalprocedure. For example, the surgical procedure can be the colonresection procedure described herein with respect to FIGS. 249-252. Insuch instances, the surgical system 13360 includes a robot 13372 and arobotic tool 13374 extending into the surgical site. The robotic toolcan be an ultrasonic device comprising an ultrasonic blade and a clamparm, for example. The surgical system 13360 also includes the remotecommand console 13370 that encompasses a robotic hub 13380. The controlunit for the robot 13372 is housed in the robotic hub 13380. A surgeon13371 is initially positioned at the remote command console 13370. Anassistant 13367 holds the handheld surgical instrument 13366, a circularstapler that extends into the surgical site. The assistant 13367 alsoholds a secondary display 13364 that communicates with the robotic hub13380. The secondary display 13364 is a mobile digital electronicdevice, which can be secured to the assistant's forearm, for example.The handheld surgical instrument 13366 includes a wireless communicationmodule. A second surgical hub 13382 is also stationed in the operatingroom. The surgical hub 13382 includes a generator module and can includeadditional modules as further described herein and in U.S. ProvisionalPatent Application Ser. No. 62/611,341, titled INTERACTIVE SURGICALPLATFORM, filed Dec. 28, 2017, the disclosure of which is hereinincorporated by reference in its entirety.

Referring primarily to FIG. 253, hubs 13380, 13382 include wirelesscommunication modules such that a wireless communication link isestablished between the two hubs 13380, 13382. Additionally, the robotichub 13380 is in signal communication with the interactive secondarydisplays 13362, 13364 within the sterile field. The hub 13382 is insignal communication with the handheld surgical instrument 13366. If thesurgeon 13371 moves over towards the patient 13361 and within thesterile field (as indicated by the reference character 13371′), thesurgeon 13371 can use one of the wireless interactive displays 13362,13364 to operate the robot 13372 away from the remote command console13370. The plurality of secondary displays 13362, 13364 within thesterile field allows the surgeon 13371 to move away from the remotecommand console 13370 without losing sight of important information forthe surgical procedure and controls for the robotic tools utilizedtherein.

The interactive secondary displays 13362, 13364 permit the clinician tostep away from the remote command console 13370 and into the sterilefield while maintaining control of the robot 13372. For example, theinteractive secondary displays 13362, 13364 allow the clinician tomaintain cooperative and/or coordinated control over the poweredhandheld surgical instrument(s) 13366 and the robotic surgical system atthe same time. In various instances, information is communicated betweenthe robotic surgical system, one or more powered handheld surgicalinstruments 13366, surgical hubs 13380, 13382, and the interactivesecondary displays 13362, 13364. Such information may include, forexample, the images on the display of the robotic surgical system and/orthe powered handheld surgical instruments, a parameter of the roboticsurgical system and/or the powered handheld surgical instruments, and/ora control command for the robotic surgical system and/or the poweredhandheld surgical instruments.

In various instances, the control unit of the robotic surgical system(e.g. the control unit 13113 of the robotic surgical system 13110) isconfigured to communicate at least one display element from thesurgeon's command console (e.g. the console 13116) to an interactivesecondary display (e.g. the display 13130). In other words, a portion ofthe display at the surgeon's console is replicated on the display of theinteractive secondary display, integrating the robot display with theinteractive secondary display. The replication of the robot display onto the display of the interactive secondary display allows the clinicianto step away from the remote command console without losing the visualimage that is displayed there. For example, at least one of theinteractive secondary displays 13362, 13364 can display information fromthe robot, such as information from the robot display and/or thesurgeon's command console 13370.

In various instances, the interactive secondary displays 13362, 13364are configured to control and/or adjust at least one operating parameterof the robotic surgical system. Such control can occur automaticallyand/or in response to a clinician input. Interacting with atouch-sensitive screen and/or buttons on the interactive secondarydisplay(s) 13362, 13364, the clinician is able to input a command tocontrol movement and/or functionality of the one or more robotic tools.For example, when utilizing a handheld surgical instrument 13366, theclinician may want to move the robotic tool 13374 to a differentposition. To control the robotic tool 13374, the clinician applies aninput to the interactive secondary display(s) 13362, 13364, and therespective interactive secondary display(s) 13362, 13364 communicatesthe clinician input to the control unit of the robotic surgical systemin the robotic hub 13380.

In various instances, a clinician positioned at the remote commandconsole 13370 of the robotic surgical system can manually override anyrobot command initiated by a clinician input on the one or moreinteractive secondary displays 13362, 13364. For example, when aclinician input is received from the one or more interactive secondarydisplays 13362, 13364, a clinician positioned at the remote commandconsole 13370 can either allow the command to be issued and the desiredfunction performed or the clinician can override the command byinteracting with the remote command console 13370 and prohibiting thecommand from being issued.

In certain instances, a clinician within the sterile field can berequired to request permission to control the robot 13372 and/or therobotic tool 13374 mounted thereto. The surgeon 13371 at the remotecommand console 13370 can grant or deny the clinician's request. Forexample, the surgeon can receive a pop-up or other notificationindicating the permission is being requested by another clinicianoperating a handheld surgical instrument and/or interacting with aninteractive secondary display 13362, 13364.

In various instances, the processor of a robotic surgical system, suchas the robotic surgical systems 13000 (FIG. 239), 13400 (FIG. 240),13150 (FIG. 246), 13100 (FIG. 248), and/or the surgical hub 13380,13382, for example, is programmed with pre-approved functions of therobotic surgical system. For example, if a clinician input from theinteractive secondary display 13362, 13364 corresponds to a pre-approvedfunction, the robotic surgical system allows for the interactivesecondary display 13362, 13364 to control the robotic surgical systemand/or does not prohibit the interactive secondary display 13362, 13364from controlling the robotic surgical system. If a clinician input fromthe interactive secondary display 13362, 13364 does not correspond to apre-approved function, the interactive secondary display 13362, 13364 isunable to command the robotic surgical system to perform the desiredfunction. In one instances, a situational awareness module in therobotic hub 13370 and/or the surgical hub 13382 is configured to dictateand/or influence when the interactive secondary display can issuecontrol motions to the robot surgical system.

In various instances, an interactive secondary display 13362, 13364 hascontrol over a portion of the robotic surgical system upon makingcontact with the portion of the robotic surgical system. For example,when the interactive secondary display 13362, 13364 is brought intocontact with the robotic tool 13374, control of the contacted robotictool 13374 is granted to the interactive secondary display 13362, 13364.A clinician can then utilize a touch-sensitive screen and/or buttons onthe interactive secondary display 13362, 13364 to input a command tocontrol movement and/or functionality of the contacted robotic tool13374. This control scheme allows for a clinician to reposition arobotic arm, reload a robotic tool, and/or otherwise reconfigure therobotic surgical system. In a similar manner as discussed above, theclinician 13371 positioned at the remote command console 13370 of therobotic surgical system can manually override any robot commandinitiated by the interactive secondary display 13362, 13364.

In one aspect, the robotic surgical system includes a processor and amemory communicatively coupled to the processor, as described herein.The memory stores instructions executable by the processor to receive afirst user input from a console and to receive a second user input froma mobile wireless control module for controlling a function of a roboticsurgical tool, as described herein.

In various aspects, the present disclosure provides a control circuit toreceive a first user input from a console and to receive a second userinput from a mobile wireless control module for controlling a functionof a robotic surgical tool, as described herein. In various aspects, thepresent disclosure provides a non-transitory computer readable mediumstoring computer readable instructions which, when executed, cause amachine to receive a first user input from a console and to receive asecond user input from a mobile wireless control module for controllinga function of a robotic surgical tool, as described herein.

A robotic surgical system may include multiple robotic arms that areconfigured to assist the clinician during a surgical procedure. Eachrobotic arm may be operable independently of the others. A lack ofcommunication may exist between each of the robotic arms as they areindependently operated, which may increase the risk of tissue trauma.For example, in a scenario where one robotic arm is configured to applya force that is stronger and in a different direction than a forceconfigured to be applied by a second robotic arm, tissue trauma canresult. For example, tissue trauma and/or tearing may occur when a firstrobotic arm applies a strong retracting force to the tissue while asecond robotic arm is configured to rigidly hold the tissue in place.

In various instances, one or more sensors are attached to each roboticarm of a robotic surgical system. The one or more sensors are configuredto sense a force applied to the surrounding tissue during the operationof the robotic arm. Such forces can include, for example, a holdingforce, a retracting force, and/or a dragging force. The sensor from eachrobotic arm is configured to communicate the magnitude and direction ofthe detected force to a control unit of the robotic surgical system. Thecontrol unit is configured to analyze the communicated forces and setlimits for maximum loads to avoid causing trauma to the tissue in asurgical site. For example, the control unit may minimize the holdingforce applied by a first robotic arm if the retracting or dragging forceapplied by a second robotic arm increases.

FIG. 255 depicts a robotic surgical system 13800 including a controlunit 13820 and a robot 13810. The robotic surgical system 13800 issimilar in many respects to the robotic surgical system 13000 includingthe robot 13002 (FIG. 239), for example. The control unit 13820 includesa processor 13822 and a display 13824. The robot 13810 includes tworobotic arms, 13830, 13840 configured to carry out various surgicalfunctions. Each of the robotic arms 13830, 13840 are independentlyoperable and are free to move in a space defining a control envelope ofthe robotic surgical system 13800. The one or more robotic arms, 13830,13840, are configured to receive a tool, such as a stapler, a radiofrequency (RF) tool, an ultrasonic blade, graspers, and/or a cuttinginstrument, for example. Other suitable surgical tool can be used. Invarious instances, the robotic arms 13830, 13840 each include adifferent tool configured to perform different functions. In otherinstances, all of the robotic arms 13830, 13840 include the same tool,although any suitable arrangement can be used.

The first robotic arm 13830 includes a first driver 13834 and a firstmotor 13836. When activated by the processor 13822, the first motor13836 drives the first driver 13834 actuating the correspondingcomponent of the first robotic arm 13830. The second robotic arm 13840includes a second driver, 13844 and a second motor 13846. When activatedby the processor 13822, the second motor 13846 drives the second driver13844 actuating the corresponding component of the second robotic arm13840.

Each of the robotic arms 13830, 13840, includes a sensor 13832, 13842 insignal communication with the processor 13822 of the control unit 13820.The sensors 13832, 13842 can be positioned on the drivers 13834, 13844,respectively, and/or on the motors 13836, 13846, respectively. Invarious instances, the sensors 13832, 13842 are configured to detect thelocation of each individual robotic arm 13830, 13840 within the controlenvelope of the robotic surgical system 13800. The sensors 13832, 13842are configured to communicate the detected locations to the processor13822 of the robotic surgical system 13800. In various instances, thepositions of the robotic arms 13830, 13840 are displayed on the display13824 of the control unit 13820. As described in more detail below, invarious instances, the processor 13822 is configured to run an algorithmto implement position limits specific to each robotic arm 13830, 13840in an effort to avoid tissue trauma and damage to the robotic surgicalsystem 13800, for example. Such position limits may increase theclinician's ability to cooperatively operate numerous robotic arms13830, 13840 of the robotic surgical system 13800 at the same time.

In various instances, the sensors 13832, 13842 are configured to detectthe force exerted by each robotic arm 13830, 13840. The sensors 13832,13842 can be torque sensors. As stated above, each robotic arm 13830,13840 of the robotic surgical system 13800 is independently operable.During a particular surgical procedure, a clinician may want to performdifferent surgical functions with each robotic arm 13830, 13840. Upondetecting the exerted forces of each robotic arm 13830, 13840, eachsensor 13832, 13842 is configured to communicate the detected forces tothe processor 13822. The processor 13822 is then configured to analyzethe communicated information and set maximum and/or minimum force limitsfor each robotic arm 13830, 13840 to reduce the risk of causing tissuetrauma, for example. In addition, the processor 13822 is configured tocontinuously monitor the exerted forces by each robotic arm 13830, 13840and, based on the direction and magnitude of the exerted forces,proportionally control each robotic arm 13830, 13840 with respect to oneanother. For example, the opposing force between two robotic arms 13830,13840 can be measured and maintained below a maximum force limit. Tomaintain the opposing force below a maximum force limit, at least one ofthe forces can be reduced, which can result in displacement of therobotic arm 13830, 13840.

By way of example, FIG. 256 depicts a surgical site and a portion of thesurgical system 13800, which includes three robotic arms, including arobotic arm 13850 (a third robotic arm) in addition to the robotic arms13830 and 13840, which are also schematically depicted in FIG. 255. Thefirst robotic arm 13830 is configured to hold a portion of stomachconnective tissue. In order to hold the portion of stomach connectivetissue, the first robotic arm 13830 exerts an upward force F_(H1). Thesecond robotic arm 13840 applies a dragging and/or cutting force F_(D2)to the tissue. Simultaneously, the third robotic arm 13850 retracts aportion of liver tissue away from the current surgical cut location,further exposing the next surgical cut location. In order to move theportion of liver tissue out of the way of the advancing second roboticarm 13840, the third robotic arm 13850 applies a retracting force F_(R3)away from the second robotic arm 13840. In various exemplifications, asthe second robotic arm 13840 advances further into the surgical site,the control unit of the robotic surgical system directs the thirdrobotic arm 13850 to increase the exerted retracting force F_(R3) tocontinue exposing the next surgical cut location. While FIG. 256 depictsa particular surgical procedure and specific robotic arms, any suitablesurgical procedure can be performed, and any suitable combination ofrobotic arms can utilize the control algorithms disclosed herein.

FIG. 257 depicts graphical representations 13852, 13854 of the forcesexerted by the robotic arms 13830, 13840, and 13850 of FIG. 256 and therelative locations of the robotic arm 13830, 13840, and 13850,respectively, from the particular surgical procedure detailed above. Thegraphical display 13852 in FIG. 257 represents the exerted forces ofeach robotic arm 13830, 13840, and 13850 over a period of time, whilethe graphical display 13854 represents the relative positions of eachrobotic arm 13830, 13840, and 13850 over the same period of time. Asdiscussed above, the first robotic arm 13830 is configured to exert aholding force F_(H1) on a portion of stomach connective tissue. Theholding force F_(H1) is represented by a solid line on the graphs 13852,13854. The second robotic arm 13840 is configured to exert a draggingand/or cutting force F_(D2) on the stomach connective tissue. Thedragging force F_(D2) is represented by a dash-dot line on the graphs13852, 13854. The third robotic arm 13850 is configured to exert aretracting force F_(R3) on a portion of liver tissue. The retractingforce F_(R3) is represented by a dotted line on the graphs 13852, 13854.

In various instances, the control unit of the robotic surgical systemimposes at least one force threshold, such as a maximum force threshold,as depicted in the graphical display 13852. Thus, the third robotic arm13850 is prevented from exerting a retraction force F_(R3) greater thanthe maximum retraction force threshold. Such maximum force limits areimposed in order to avoid tissue trauma and/or avoid damage to thevarious robotic arms 13830, 13840, and 13850, for example.

Additionally or alternatively, the control unit 13820 of the roboticsurgical system 13800 can impose least one force threshold, such as aminimum force threshold, as depicted in the graphical display 13852. Inthe depicted instance, the first robotic arm 13830 is prevented fromexerting a holding force F_(H1) less than the minimum holding forcethreshold. Such minimum force limits are imposed in order to avoidmaintain appropriate tissue tension and/or visibility of the surgicalsite, for example.

In various instances, the control unit 13820 of the robotic surgicalsystem 13800 imposes maximum force differentials detected betweenvarious robotic arms during a load control mode. In order to set maximumforce differentials, the control unit 13820 of the robotic surgicalsystem is configured to continuously monitor the difference in magnitudeand direction of opposing forces by the robotic arms. As stated above,the first robotic arm 13830 is configured to hold a portion of thestomach connective tissue by exerting a holding force F_(H1). The secondrobotic arm 13840 is configured to apply a dragging force F_(D2), whichopposes the holding force F_(H1) exerted by the first robotic arm 13830.In various instances, maximum force differentials prevent inadvertentoverloading and/or damaging an object caught between the robotic arms13830, 13840, and 13850. Such objects include, for example, surroundingtissue and/or surgical components like clasps, gastric bands, and/orsphincter reinforcing devices. F_(max) opposing represents the maximumforce differential set by the control unit 13820 in this particularexemplification.

As can be seen in the graphical display 13852, the holding force F_(H1)and the dragging force F_(D2) both increase in magnitude at thebeginning of the surgical procedure. Such an increase in magnitudes canindicate a pulling of the tissue. The holding force F_(H1) and thedragging force F_(D2) increase in opposite directions to a point wherethe difference between the opposing forces is equal to F_(max opposing).In the graphic display 13852, the slanted lines highlight the point intime when F_(max opposing) is reached. Upon reaching F_(max opposing),the processor 13822 instructs the first robotic arm 13830 to reduce theholding force F_(H1) and continues to allow the second robotic arm 13840to exert the dragging force F_(D2) at the same value, and may allow aclinician to increase the dragging force. In various instances, thevalue of F_(max opposing) is set by the processor 13822 based on variousvariables, such as the type of surgery and/or relevant patientdemographics. In various instances, F_(max opposing) is a default valuestored in a memory of the processor 13822.

The relative positions of the robotic arms 13830, 13840, and 13850within the surgical site are depicted in the graph display 13854 of FIG.257. As the first robotic arm 13830 exerts a holding force F_(H1) on thestomach connective tissue and the third robotic arm 13850 exerts aretracting force F_(R3) on the liver tissue, the surgical site becomesclear and allows the second robotic arm 13840 to exert a dragging and/orcutting force F_(D2) on the desired tissue. The second robotic arm 13840and the third robotic arm 13850 become farther away from the firstrobotic arm 13830 as the procedure progresses. When the forcedifferential F_(max opposing) is reached between the holding forceF_(H1) and the dragging force F_(D2), the first robotic arm 13830 ismoved closer towards the second robotic arm 13840, lessening the exertedholding force F_(H1) by the first robotic arm 13830. In one aspect, theprocessor 13822 can transition the first robotic arm 13830 from the loadcontrol mode into a position control mode such that the position of thefirst robotic arm 13830 is held constant. As depicted in the graphicalrepresentations of FIG. 257, when the first robotic arm 13830 is held ina constant position, the force control for the second robotic arm 13840can continue to displace the second robotic arm 13840.

In various instances, the control unit 13820 of the robotic surgicalsystem directs the first robotic arm 13830 to hold a specific positionuntil a pre-determined force threshold between the first robotic arm13830 and a second robotic arm 13840 is reached. When the pre-determinedforce threshold is reached, the first robotic arm 13830 is configured toautomatically move along with the second robotic arm 13840 in order tomaintain the pre-determined force threshold. The first robotic arm 13830stops moving (or may move at a different rate) when the detected forceof the second robotic arm 13840 no longer maintains the pre-determinedforce threshold.

In various instances, the control unit 13820 of the robotic surgicalsystem is configured to alternate between the position control mode andthe load control mode in response to detected conditions by the roboticarms 13830, 13840, and 13850. For example, when the first robotic arm13830 and the second robotic arm 13840 of the robotic surgical system13800 are freely moving throughout a surgical site, the control unit13820 may impose a maximum force that each arm 13830, 13840 can exert.In various instances, the first and second arms 13830, 13840 eachinclude a sensor configured to detect resistance. In other instances,the sensors can be positioned on a surgical tool, such as an intelligentsurgical stapler or jawed tool. A resistance can be encountered uponcontact with tissue and/or other surgical instruments. When suchresistance is detected, the control unit 13820 may activate the loadcontrol mode and lower the exerted forces by one and/or more than one ofthe robotic arms 13830, 13840 to, for example, reduce damage to thetissue. In various instances, the control unit 13820 may activate theposition control mode and move the one and/or more than one of therobotic arms 13830, 13840 to a position where such resistance is nolonger detected.

In one aspect, the processor 13822 of the control unit 13820 isconfigured to switch from the load control mode to the position controlmode upon movement of a surgical tool mounted to one of the robotic arms13830, 13840 outside a defined surgical space. For example, if one ofthe robotic arms 13830, 13840 moves out of a defined boundary around thesurgical site, or into abutting contact with an organ or other tissue,or too close to another surgical device, the processor 13822 can switchto a position control mode and prevent further movement of the roboticarm 13830, 13840 and/or move the robotic arm 13830, 13840 back withinthe defined surgical space.

Turning now to the flow chart shown in FIG. 258, an algorithm 13500 isinitiated at step 13501 when the clinician and/or the robotic surgicalsystem activates one or more of the robotic arms at step 13505. Thealgorithm 13500 can be employed by the robotic surgical system 13800 inFIG. 255, for example. Each robotic arm is in signal communication withthe processor 13822 of the robotic surgical system. Followingactivation, each robotic arm is configured to send information to theprocessor. In various instances, the information may include, forexample, identification of the tool attachment and/or the initialposition of the activated robotic arm. In various instances, suchinformation is communicated automatically upon attachment of the tool tothe robotic arm, upon activation of the robotic arm by the roboticsurgical system, and/or after interrogation of the robotic arm by theprocessor, although the information may be sent at any suitable time.Furthermore, the information may be sent automatically and/or inresponse to an interrogation signal.

Based on the information gathered from each of the activated roboticarms at step 13510, the processor is configured to set a position limitfor each specific robotic arm within a work envelope of the roboticsurgical system at step 13515. The position limit can setthree-dimensional boundaries for where each robotic arm can travel. Thesetting of position limits allows for efficient and cooperative usage ofeach activated robotic arm while, for example, preventing trauma tosurrounding tissue and/or collisions between activated robotic arms. Invarious instances, the processor includes a memory including a set ofstored data to assist in defining each position limit. The stored datacan be specific to the particular surgical procedure, the robotic toolattachment, and/or relevant patient demographics, for example. Invarious instances, the clinician can assist in the definition of theposition limit for each activated robotic arm. The processor isconfigured to determine if the robotic arms are still activated at step13520. If the processor determines that the robotic arms are no longeractivated, the processor is configured to end position monitoring atstep 13522. Once the processor determines that the robotic arms arestill activated, the processor is configured to monitor the position ofeach activated robotic arm at step 13525.

The processor is then configured to evaluate whether the detectedposition is within the predefined position limit(s) at step 13530. Ininstances where information is unable to be gathered from the roboticarm and clinician input is absent, a default position limit is assignedat step 13533. Such a default position limit assigns a conservativethree-dimensional boundary to minimize, for example, tissue traumaand/or collisions between robotic arms. If the detected limit is withinthe position limit, the processor is configured to allow the roboticarm(s) to remain in position and/or freely move within the surgical siteat step 13535, and the monitoring process continues as long as therobotic arm is still activated. If the detected limit is outside of theposition limit, the processor is configured to move the robotic arm backinto the position limit at step 13532, and the monitoring processcontinues as long as the robotic arm is still activated.

The processor is configured to continuously monitor the position of eachrobotic arm at step 13525. In various instances, the processor isconfigured to repeatedly send interrogation signals in pre-determinedtime intervals. As discussed above, if the detected position exceeds theposition limit set for the specific robotic arm, in certain instances,the processor is configured to automatically move the robotic arm backwithin the three-dimensional boundary at step 13532. In certaininstances, the processor is configured to re-adjust the position limitsof the other robotic arms in response to one robotic arm exceeding itsoriginal position limit. In certain instances, prior to moving therobotic arm back within its position limit and/or adjusting the positionlimits of the other robotic arms, the processor is configured to alertthe clinician. If the detected position is within the position limit setfor the robotic arm, the processor permits the robotic arm to remain inthe same position and/or freely travel until the detected positionexceeds the position limit at step 13535. If the processor is unable todetect the position of the robotic arm, the processor is configured toalert the clinician and/or assign the robotic arm with the defaultposition limit at step 13533. The processor is configured to monitor theposition of each robotic arm until the surgery is completed and/or therobotic arm is deactivated.

Similar to the algorithm of FIG. 258, the flow chart of FIG. 259 depictsan algorithm 13600 that is initiated at step 13601 when a clinicianand/or a robotic surgical system activates one or more of the roboticarms at step 13605. The algorithm 13600 can be employed by the roboticsurgical system 13800 in FIG. 255, for example. Each robotic arm is insignal communication with the processor. Following activation, eachrobotic arm is configured to send information to the processor at step13610. In various instances, the information may include, for example,identification of the tool attachment, exerted forces detected by one ormore force sensors on the robotic arm, and/or the initial position ofthe activated robotic arm. In various instances, such information iscommunicated automatically upon attachment of the tool to the roboticarm, upon activation of the robotic arm by the robotic surgical system,and/or after interrogation of the robotic arm by the processor, althoughthe information may be sent at any suitable time. Furthermore, theinformation may be sent automatically and/or in response to aninterrogation signal.

Based on the information gathered from each of the activated roboticarms, the processor is configured to set a force limit for each specificrobotic arm at step 13615. The force limit sets maximum and minimumforce thresholds for forces exerted by each robotic arm. Additionally oralternatively, a force limit can be the maximum force differentialbetween two or more arms. The setting of force limits allows forefficient and cooperative usage of all of the activated robotic armswhile, for example, preventing trauma to surrounding tissue and/ordamage to the robotic arms. In various instances, the processor includesa memory including a set of stored data to assist in defining each forcelimit. The stored data can be specific to the particular surgicalprocedure, the robotic tool attachment, and/or relevant patientdemographics, for example. In various instances, the clinician canassist in the definition of the force limit for each activated roboticarm. In instances where information is unable to be gathered from therobotic arm and clinician input is absent, a default force limit isassigned. Such a default force limit assigns conservative maximum andminimum force thresholds to minimize, for example, tissue trauma and/ordamage to the robotic arms.

The processor is configured to determine if the robotic arm is active atstep at step 13620. If the processor determines that the robotic arm hasbeen deactivated, the processor is configured to end force monitoring atstep 13622. Once it has been determined that the robotic arm is stillactivated at step 13620, the processor is configured to continuouslymonitor the force exerted by each robotic arm at step 13625. In variousinstances, the processor is configured to repeatedly send interrogationsignals in pre-determined time intervals. If the detected force exceedsthe maximum force threshold set for the specific robotic arm, in certaininstances, the processor is configured to automatically decrease theforce exerted by the robotic arm and/or decrease an opposing forceexerted by another robotic arm at step 13632. In certain instances, theprocessor is configured to re-adjust the force limits assigned to theother robotic arms in response to one robotic arm exceeding its originalforce limits. In certain instances, prior to adjusting the force exertedby the robotic arm, adjusting the opposing force exerted by anotherrobotic arm, and/or adjusting the force limits of the other roboticarms, the processor is configured to alert the clinician. If thedetected force is within the force limit set for the robotic arm, therobotic arm is permitted to maintain the exertion of the force and/orthe clinician can increase or decrease the exerted force until the forceis out of the set force limit at step 13635. If the processor is unableto detect the exerted force of the robotic arm, the processor isconfigured to alert the clinician and/or assign the robotic arm with adefault force limit at step 13633. The processor is configured tomonitor the exerted force of each robotic arm until the surgery iscompleted and/or the robotic arm is deactivated at step 13620.

Similar to the algorithms of FIGS. 258 and 259, the flow chart of FIG.260 depicts an algorithm 13700 that is initiated 13701 when a clinicianand/or a robotic surgical system activates one or more of the roboticarms 13705. The algorithm 13700 can be employed by the robotic surgicalsystem 13800 in FIG. 255, for example. Each robotic arm is in signalcommunication with the processor. Following activation, each robotic armis configured to send information to the processor at step 13710. Invarious instances, the information may include, for example,identification of the tool attachment, forces detected by one or moreforce sensors on the robotic arm, and/or the initial position of theactivated robotic arm. In various instances, such information iscommunicated automatically upon attachment of the tool to the roboticarm, upon activation of the robotic arm by the robotic surgical system,and/or after interrogation of the robotic arm by the processor, althoughthe information may be sent at any suitable time. In various instances,the information is sent automatically and/or in response to aninterrogation signal.

Based on the information gathered from all of the activated roboticarms, the processor is configured to set both a position limit within awork envelope of the robotic surgical system and a force limit for eachspecific robotic arm at step 13715. The position limit setsthree-dimensional boundaries for where each robotic arm can travel. Thesetting of position limits allows for efficient and cooperative usage ofall of the activated robotic arms while, for example, preventing traumato surrounding tissue and/or collisions between activated robotic arms.The force limit sets maximum and/or minimum force thresholds for forcesexerted by each robotic arm. Additionally or alternatively, a forcelimit can be the maximum force differential between two or more arms.The setting of force limits allows for efficient and cooperative usageof the activated robotic arms while, for example, preventing trauma tosurrounding tissue and/or damage to the robotic arms.

In various instances, the processor includes a memory including a set ofstored data to assist in defining each position limit and force limit.The stored data can be specific to the particular surgical procedure,the robotic tool attachment, and/or relevant patient demographics, forexample. In various instances, the clinician can assist in thedefinition of the position limit and force limit for each activatedrobotic arm. In instances where information is unable to be gatheredfrom the robotic arm and clinician input is absent, a default positionlimit and/or default force limit is assigned to the robotic arm. Such adefault position limit assigns a conservative three-dimensional boundaryto minimize, for example, tissue trauma and/or collisions betweenrobotic arms, while the default force limit assigns conservative maximumand/or minimum force thresholds to minimize, for example, tissue traumaand/or damage to the robotic arms. In various instances, the processoris configured to adjust the position limit of one robotic arm based onthe force limit of another robotic arm, adjust the force limit of onerobotic arm based on the position limit of another robotic arm, and viceversa.

The processor is configured to determine whether the robotic arm isactive at step 13720. Once the processor has determined that the roboticarm is activated at step 13720, the processor is configured tocontinuously monitor the position of each arm 13737 and the forceexerted by each robotic arm at step 13725. If the robotic arm is nolonger activated, the processor is configured to end position monitoringat step 13727 and end force monitoring at step 13722. In variousinstances, the processor is configured to repeatedly send interrogationsignals in pre-determined time intervals. If the detected positionexceeds the position limit set for the specific robotic arm, in certaininstances, the processor is configured to automatically move the roboticarm back within the three-dimensional boundary at step 13742. In certaininstances, prior to moving the robotic arm back within its positionlimit, the processor is configured to alert the clinician. If thedetected position is within the position limit set for the robotic arm,the robotic arm is permitted to remain in the same position and/orfreely travel until the detected position exceeds the position limit atstep 13745. If the processor is unable to detect the position of therobotic arm, the processor is configured to alert the clinician and/orrewrite the original position limit of the robotic arm with the defaultposition limit at step 13743. The processor is configured to monitor theposition of each robotic arm until the surgery is completed and/or therobotic arm is deactivated.

In certain instances, the robotic surgical system includes a manualoverride configured to control the position of each robotic arm. If thedetected force exceeds the maximum force threshold set for the specificrobotic arm, in certain instances, the processor is configured toautomatically decrease the force exerted by the robotic arm and/ordecrease an opposing force exerted by another robotic arm at step 13732.In certain instances, prior to decreasing the force exerted by therobotic arm and/or decrease the opposing force exerted by anotherrobotic arm, the processor is configured to alert the clinician. If thedetected force is within the force limit set for the robotic arm, therobotic arm is permitted to maintain the exertion of the force and/orincrease or decrease the exerted force until the force is out of the setforce limit at step 13735. If the processor is unable to detect theexerted force of the robotic arm, the processor is configured to alertthe clinician and/or rewrite the original force limit of the robotic armwith the default force limit at step 13733. The processor is configuredto monitor the exerted force of each robotic arm until the surgery iscompleted and/or the robotic arm is deactivated.

In various instances, the position monitoring system and the forcemonitoring system are interconnected. In certain instances, the forcemonitoring system can override the resultant decision 13742, 14743,14745 of the position detection step 13740. In certain instances, theposition monitoring system can override the resultant decision 13732,13733, 13735 of the force detection step 13730. In other instances, theposition monitoring system and the force monitoring system areindependent of one another.

A clinician can manually override the automatic adjustments implementedin the automatic load and/or position control mode(s) described herein.The manual override can be a one-time adjustment to the surgical robot.In other instances, the manual override can be a setting that turns offthe automatic load and/or position mode for a specific surgical action,a specific duration, and/or a global override for the entire procedure.

In one aspect, the robotic surgical system includes a processor and amemory communicatively coupled to the processor, as described herein.The processor is communicatively coupled to a first force sensor and asecond force sensor, and the memory stores instructions executable bythe processor to affect cooperative movement of a first robotic arm anda second robotic arm based on a first input from the first force sensorand from a second input from the second force sensor in a load controlmode, as described herein.

In various aspects, the present disclosure provides a control circuit toaffect cooperative movement of a first robotic arm and a second roboticarm, as described herein. In various aspects, the present disclosureprovides a non-transitory computer readable medium storing computerreadable instructions which, when executed, cause a machine to affectcooperative movement of a first robotic arm and a second robotic arm, asdescribed herein.

During a particular surgical procedure, clinicians may rely on one ormore powered handheld surgical instruments in addition to a roboticsurgical system. In various instances, the instruments are controlledand monitored through different platforms, which may inhibitcommunication between the instruments and the robotic surgical system.For example, the instruments can be produced by different manufacturersand even by competitors. Such instruments may have differentcommunication packages and/or communication and/or linking protocols.The lack of communication between a powered instrument and the roboticsurgical system may hinder cooperative and/or coordinated usage and maycomplicate the surgical procedure for the clinician. For example, eachsurgical instrument may include an individual display to communicatevarious information and operating parameters. In such a scenario, aclinician may have to look at numerous instrument-specific displays tomonitor the operating status of and analyze data gathered by eachdevice.

In various instances, a robotic surgical system is configured to detectthe presence of other powered surgical instruments that are controlledby platforms other than the robotic surgical system. The roboticsurgical system can incorporate a hub, i.e., a robotic hub like therobotic hubs 122 (FIG. 2) and 222 (FIG. 9), which can detect otherpowered surgical instruments, for example. In other instances, astand-alone surgical hub like the hub 106 (FIGS. 1-3) or the hub 206(FIG. 9) in communication with the robotic surgical system canfacilitate detection of the non-robotic surgical instruments andcooperative and/or coordinated usage of the detected surgicalinstruments with the robotic surgical system. The hub, which can be arobotic hub or a surgical hub, is configured to display the position andorientation of the powered surgical instruments with respect to the workenvelope of the robotic surgical system. In certain instances, the workenvelope can be an operating room, for example. A surgical hub havingspatial awareness capabilities is further described herein and in U.S.Provisional Patent Application Ser. No. 62/611,341, titled INTERACTIVESURGICAL PLATFORM, filed Dec. 28, 2017, the disclosure of which isherein incorporated by reference in its entirety. In one aspect, the hubcan first ascertain the boundaries of the work envelope and then detectthe presence of other powered surgical instruments within the workenvelope.

FIG. 261 depicts a surgical system 13860 including a robotic surgicalsystem 13865, a surgical instrument 13890, and a surgical hub 13870. Thesurgical instrument 13890 is a powered handheld instrument, and can be amotorized surgical stapler, such as the motorized linear staplerdepicted in FIG. 262, for example. The surgical system 13865 can besimilar in many respects to the robotic surgical system 13000 (FIG.239), for example. As described herein, the surgical hub 13870 can beincorporated into the robotic surgical system 13865, for example. Thesurgical hub 13870 is configured to be in signal communication with therobotic surgical system 13865 and the surgical instrument 13890. Inother instances, the surgical system 13860 can include additionalhandheld surgical instruments. The robotic surgical system 13865includes a robot 13861, which can be similar to the robot 13002, forexample. The robotic surgical system 13865 also includes a control unit13862 and a surgeon's command console, or remote control module, 13864.The surgeon's command console 13864 is configured to receive a clinicianinput. The control unit 13862 includes a robot display 13868 and aprocessor 13866. The surgical instrument 13890 includes a display 13894and a processor 13892.

In various instances, the surgical hub 13870 includes a surgical hubdisplay 13880, which can be similar to the displays of the visualizationsystem 108 (FIG. 1). The surgical hub display 13880 can include, forexample, a heads up display. The surgical hub 13880 is configured todetect the presence of the surgical instrument 13890 within a certaindistance of the surgical hub 13870. For example, the surgical hub 13870is configured to detect the presence of all activated surgicalinstruments 13890 within one operating room, although any suitabledistance can be monitored. In various instances, the surgical hub 13870is configured to display the presence of all activated surgicalinstruments 13890 on the surgical hub display 13880.

A particular handheld surgical instrument communicates via a firstcommunication process through a first language. A particular roboticsurgical system communicates via a second communication process througha second language. In various instances, the first communication processis the same as the second communication process. When the firstcommunication process is the same as the second communication process,the surgical instrument 13890 is configured to directly communicateinformation to the surgical hub 13870 and/or to the robotic surgicalsystem 13865. Such information includes, for example, a model numberand/or type of the surgical instrument, a position of the surgicalinstrument, an operating status of the surgical instrument, and/or anyother relevant parameter of the surgical instrument.

In various instances, the first communication process is different fromthe second communication process. For example, a surgical system (e.g. arobot) developed by a first manufacturer may utilize a first proprietarylanguage or communication scheme and a surgical system (e.g. a handheldsurgical tool) developed by a second manufacturer may utilize a second,different proprietary language or communication scheme. Despite thelanguage difference/barrier, the surgical hub 13870 and/or surgicalrobot 13865 is configured to sense surgical instruments 13890 thatoperate on different communication processes. When the surgical hub13870 does not recognize the communication process utilized by aparticular powered handheld surgical instrument, the surgical hub 13870is configured to detect various signals, such as Wi-Fi and Bluetoothtransmissions emitted by activated powered handheld surgicalinstruments. Based on the detected signal transmissions, the surgicalhub 13870 is configured to alert the clinician of all powered handheldsurgical instruments that do not use the same communication process asthe robotic surgical system 13865. All data received from newly-detectedpowered handheld surgical instruments can be stored within the surgicalhub 13870 so that the newly-detected powered handheld surgicalinstruments are recognized by the surgical hub 13870 in the future.

In various instances, the surgical hub 13870 is configured to detect thepresence of powered handheld surgical instruments by sensing a magneticpresence of a battery, power usage, and/or electro-magnetic fieldemitted from activated powered handheld surgical instruments, regardlessof whether the activated powered handheld surgical instruments made anyattempt to communicate with another surgical instrument, such as therobotic surgical system.

The robot 13861 and the surgical instrument 13890 are exemplified in anexample surgical procedure in FIG. 262. In this exemplification, thesurgical instrument 13890 is an articulating linear stapler. As depictedin FIG. 262, the surgical instrument 13890 includes a motor 13895 in thehandle 13892 thereof. In other instances, the surgical instrument 13890can include a plurality of motors positioned throughout the surgicalinstrument. The motor 13895 is configured to emit an electromagneticfield 13896, which can be detected by the robotic surgical system 13865or the surgical hub 13870. For example, the main robot tower or themodular control tower of the surgical hub 13870 can include a receiverfor detecting the electromagnetic fields within the operating room.

In one aspect, a processor of the robotic surgical system (e.g. aprocessor of the control unit 13862) is configured to calculate aboundary around the surgical instrument 13890. For example, based on theelectromagnetic field 13896 and corresponding type of surgicalinstrument, the processor can determine the dimensions of the surgicalinstrument 13890 and possible range of positions thereof. For example,when the surgical instrument 13890 includes one or more articulationjoints 13891, the range of positions can encompass the articulatedpositions of the surgical instrument 13890.

In one instance, the robotic surgical system can calculate a first widerboundary B₂ around the surgical instrument. When a robotic surgical toolapproaches the wider boundary B₂, the robotic surgical tool 13861 canissue a notification or warning to the surgeon that the robotic surgicaltool attached to the robot 13861 is approaching another surgicalinstrument 13890. In certain instances, if the surgeon continues toadvance the robotic surgical tool toward the surgical instrument 13890and to a second narrower boundary B₁, the robotic surgical system 13865can stop advancing the robotic surgical tool. For example, if therobotic surgical tool crosses the narrower boundary B₁, advancement ofthe robotic surgical tool can be stopped. In such instances, if thesurgeon still desires to continue advancing the robotic surgical toolwithin the narrower boundary B₁, the surgeon can override the hard stopfeature of the robotic surgical system 13865.

Referring again to FIG. 261, the surgical system 13860 includes multipledisplay monitors. Each handheld surgical instrument 13890 and therobotic surgical system 13865 is configured to communicate a videoand/or image feed representative of the display on each device to thesurgical hub 13870 and/or the hub display 13880. Such video and/or imagefeeds can include operating parameters of and/or detected conditions byeach handheld surgical instrument 13890 and/or the robotic surgicalsystem 13865. The hub 13870 is configured to control the displayed videoand/or image feeds on each of the one or more display monitorsthroughout the system 13800. In various instances, each of the displaymonitors displays an individual video and/or image feed from aparticular surgical device or system. In various instances, theindividual video and/or image feed can be overlaid with additionalinformation and/or video and/or image feeds from other devices orsystems. Such information can include operating parameters and/ordetected conditions. The surgical hub 13870 is configured to requestwhich display monitor displays which video and/or image feed. In otherwords, the communication link between the surgical hub 13870 and the hubdisplay 13880 allows the surgical hub 13870 to dictate which videoand/or image feed is assigned to which display monitor, while directcontrol of the one or more display monitors remains with the video hub.In various instances, the hub display 13880 is configured to separateone or more of the display monitors from the surgical hub 13870 andallow a different surgical hub or surgical device to display relevantinformation on the separated display monitors.

In various instances, the surgical hub is configured to communicatestored data with other data systems within an institution data barrierallowing for cooperative utilization of data. Such established datasystems may include, for example, an electronic medical records (EMR)database. The surgical hub is configured to utilize the communicationbetween the surgical hub and the EMR database to link overall surgicaltrends for the hospital with local data sets recorded during use of thesurgical hub.

In various instances, the surgical hub is located in a particularoperating room at a hospital and/or surgery center. As shown in FIG.263, the hospital and/or surgery center includes operating rooms, OR₁,OR₂, OR₃, and OR₄. Three of the operating rooms OR₂, OR₃, and OR₄ shownin FIG. 263 includes a surgical hub 13910, 13920, 13930, respectively,however any suitable number of surgical hubs can be used. Each surgicalhub 13910, 13920, 13930 is configured to be in signal communication withone another, represented by signal arrows A. Each surgical hub 13910,13920, 13930 is also configured to be in signal communication with aprimary server 13940, represented by signal arrows B in FIG. 263.

In various exemplifications, as data is communicated between thesurgical hub(s) 13910, 13920, 13930 and the various surgical instrumentsduring a surgical procedure, the surgical hub(s) 13910, 13920, 13930 areconfigured to temporarily store the communicated data. At the end of thesurgical procedure and/or at the end of a pre-determined time period,each surgical hub 13910, 13920, 13930 is configured to communicate thestored information to the primary server 13940. Once the storedinformation is communicated to the primary server 13940, the informationcan be deleted from the memory of the individual surgical hub 13910,13920, 13930. The stored information is communicated to the primaryserver 13940 to alleviate the competition amongst the surgical hubs13910, 13920, 13930 for bandwidth to transmit the stored data to cloudanalytics “C”, for example. Instead, the primary server 13940 isconfigured to compile and store and communicated data. The primaryserver 13940 is configured to be the single clearinghouse forcommunication of information back to the individual surgical hubs 13910,13920, 13930 and/or for external downloading. In addition, as all of thedata is stored in one location in the primary server 13940, the data isbetter protected from data destructive events, such as power surgesand/or data intrusion, for example. In various instances, the primaryserver 13940 includes additional server-level equipment that allows forbetter data integrity. Examples of cloud systems are further describedherein and in U.S. Provisional Patent Application Ser. No. 62/611,340,titled CLOUD-BASED MEDICAL ANALYTICS, filed Dec. 28, 2017, thedisclosure of which is herein incorporated by reference in its entirety.

Referring to FIGS. 263 and 264, as data begins to be communicated fromeach control hub 13910, 13920, 13930 to the primary server 13940, aqueue 13990 is created to prioritize the order in which data iscommunicated. In various instances, the queue 13990 prioritizes data asfirst in, first out, although any suitable prioritization protocol canbe used. In various instances, the queue 13990 is configured tore-prioritize the order in which received data is communicated whenpriority events and/or abnormal data are detected. As illustrated inFIG. 264, a first surgical hub communicates a first set of data at atime t=1 at block 13960. As the first set of data is the only data inthe queue for external output at block 13992, the first set of data isthe first to be communicated. Thus, the queue 13990 prioritizes thefirst set of data for external output at block 13965. A second surgicalhub communicates a second set of data at a time t=2 at block 13970. Atthe time t=2, the first set of data has not been externally communicatedat block 13994. However, because no priority events and/or abnormal dataare present in the second set of data, the second set of data is thesecond in line to be externally communicated at block 13975. A thirdsurgical hub communicates a third set of data flagged as urgent at atime t=3 at block 13980. At the time t=3, the first set of data and thesecond set of data have not been externally communicated, however apriority event has been detected in the third set of data at block13985. The queue is configured to re-prioritize the sets of data toallow the prioritized third set of data to be in the first position forexternal output at block 13996 above the first set of data and thesecond set of data collected at time t=1 and t=2, respectively.

In one aspect, the surgical hub includes a processor and a memorycommunicatively coupled to the processor, as described herein. Thememory stores instructions executable by the processor to detect thepresence of a powered surgical instrument and represent the poweredsurgical instrument on a hub display, as described herein.

In various aspects, the present disclosure provides a control circuit todetect the presence of a powered surgical instrument and represent thepowered surgical instrument on a hub display, as described herein. Invarious aspects, the present disclosure provides a non-transitorycomputer readable medium storing computer readable instructions which,when executed, cause a machine to detect the presence of a poweredsurgical instrument and represent the powered surgical instrument on ahub display, as described herein.

Another robotic surgical system is the VERSIUS® robotic surgical systemby Cambridge Medical Robots Ltd. of Cambridge, England. An example ofsuch a system is depicted in FIG. 265. Referring to FIG. 265, thesurgical robot includes an arm 14400 which extends from a base 14401.The arm 14400 includes a number of rigid limbs 14402 that are coupledtogether by revolute joints 14403. The most proximal limb 14402 a iscoupled to the base 14401 by a joint 14403 a. The most proximal limb14402 a and the other limbs (e.g. limbs 14402 b and 14402 c) are coupledin series to further limbs at the joints 14403. A wrist 14404 can bemade up of four individual revolute joints. The wrist 14404 couples onelimb (e.g. limb 14402 b) to the most distal limb (e.g. the limb 14402 cin FIG. 265) of the arm 14400. The most distal limb 14402 c carries anattachment 14405 for a surgical tool 14406. Each joint 14403 of the arm14400 has one or more motors 14407, which can be operated to causerotational motion at the respective joint, and one or more positionand/or torque sensors 14408, which provide information regarding thecurrent configuration and/or load at that joint 14403. The motors 14407can be arranged proximally of the joints 14403 whose motion they drive,so as to improve weight distribution, for example. For clarity, onlysome of the motors and sensors are shown in FIG. 265. The arm 14400 maybe generally as described in Patent Application PCT/GB2014/053523 andInternational Patent Application Publication No. WO 2015/025140, titledDISTRIBUTOR APPARATUS WITH A PAIR OF INTERMESHING SCREW ROTORS, filedAug. 18, 2014, which published on Feb. 26, 2015, and which is hereinincorporated by reference in its entirety. Torque sensing is furtherdescribed in U.S. Patent Application Publication No. 2016/0331482,titled TORQUE SENSING IN A SURGICAL ROBOTIC WRIST, filed May 13, 2016,which published on Nov. 17, 2016, which is herein incorporated byreference in its entirety.

The arm 14400 terminates in the attachment 14405 for interfacing withthe surgical tool 14406. The attachment 14405 includes a drive assemblyfor driving articulation of the surgical tool 14406. Movable interfaceelements of a drive assembly interface mechanically to engagecorresponding movable interface elements of the tool interface in orderto transfer drive motions from the robot arm 14400 to the surgical tool14406. One surgical tool may be exchanged for another surgical tool oneor more times during a typical operation. The surgical tool 14406 can beattachable and detachable from the robot arm 14400 during the operation.Features of the drive assembly interface and the tool interface can aidin their alignment when brought into engagement with each other, so asto reduce the accuracy with which they need to be aligned by the user. Abar for guiding engagement of a robotic arm and surgical tool is furtherdescribed in U.S. Patent Application Publication No. 2017/0165012,titled GUIDING ENGAGEMENT OF A ROBOT ARM AND SURGICAL INSTRUMENT, filedDec. 9, 2016, which published on Jun. 15, 2017, which is hereinincorporated by reference in its entirety.

The surgical tool 14406 further includes an end effector for performingan operation. The end effector may take any suitable form. For example,the end effector may include smooth jaws, serrated jaws, a gripper, apair of shears, a needle for suturing, a camera, a laser, a knife, astapler, one or more electrodes, an ultrasonic blade, a cauterizer,and/or a suctioner. Alternative end effectors are further describedherein. The surgical tool 14406 can include an articulation junctionbetween the shaft and the end effector, which can permit the endeffector to move relative to the shaft of the tool. The joints in thearticulation junction can be actuated by driving elements, such aspulley cables. Pulley arrangements for articulating the surgical tool14406 are described in U.S. Patent Application Publication No.2017/0172553, titled PULLEY ARRANGEMENT FOR ARTICULATING A SURGICALINSTRUMENT, filed Dec. 9, 2016, which published on Jun. 22, 2017, whichis herein incorporated by reference in its entirety. The drivingelements for articulating the surgical tool 14406 are secured to theinterface elements of the tool interface. Thus, the robot arm 14400 cantransfer drive motions to the end effector as follows: movement of adrive assembly interface element moves a tool interface element, whichmoves a driving element in the tool 14406, which moves a joint of thearticulation junction, which moves the end effector. Control of arobotic arm and tool, such as the arm 14400 and the tool 14406, arefurther described in U.S. Patent Application Publication No.2016/0331482, titled TORQUE SENSING IN A SURGICAL ROBOTIC WRIST, filedMay 13, 2016 and which was published on Nov. 17, 2016, and inInternational Patent Application Publication No. WO 2016/116753, titledROBOT TOOL RETRACTION, filed Jan. 21, 2016 and which was published onJul. 28, 2016, each of which is herein incorporated by reference in itsentirety.

Controllers for the motors 14407 and the sensors 14408 (e.g. torquesensors and encoders) are distributed within the robot arm 14400. Thecontrollers are connected via a communication bus to a control unit14409. Examples of communication paths in a robotic arm, such as the arm14400, are further described in U.S. Patent Application Publication No.2017/0021507, titled DRIVE MECHANISMS FOR ROBOT ARMS and in U.S. PatentApplication Publication No. 2017/0021508, titled GEAR PACKAGING FORROBOTIC ARMS, each of which was filed Jul. 22, 2016 and published onJan. 26, 2017, and each of which is herein incorporated by reference inits entirety. The control unit 14409 includes a processor 14410 and amemory 14411. The memory 14411 can store software in a non-transient waythat is executable by the processor 14410 to control the operation ofthe motors 14407 to cause the arm 14400 to operate in the mannerdescribed herein. In particular, the software can control the processor14410 to cause the motors 14407 (for example via distributedcontrollers) to drive in dependence on inputs from the sensors 14408 andfrom a surgeon command interface 14412.

The control unit 14409 is coupled to the motors 14407 for driving themin accordance with outputs generated by execution of the software. Thecontrol unit 14409 is coupled to the sensors 14408 for receiving sensedinput from the sensors 14408, and to the command interface 14412 forreceiving input from it. The respective couplings may, for example, eachbe electrical or optical cables, and/or may be provided by a wirelessconnection. The command interface 14412 includes one or more inputdevices whereby a user can request motion of the end effector in adesired way. The input devices could, for example, be manually operablemechanical input devices such as control handles or joysticks, orcontactless input devices such as optical gesture sensors. The softwarestored in the memory 14411 is configured to respond to those inputs andcause the joints of the arm 14400 and the tool 14406 to moveaccordingly, in compliance with a pre-determined control strategy. Thecontrol strategy may include safety features which moderate the motionof the arm 144400 and the tool 14406 in response to command inputs. Insummary, a surgeon at the command interface 14412 can control thesurgical tool 14406 to move in such a way as to perform a desiredsurgical procedure. The control unit 14409 and/or the command interface14412 may be remote from the arm 14400.

Additional features and operations of a surgical robot system, such asthe robotic surgical system depicted in FIG. 265, are further describedin the following references, each of which is herein incorporated byreference in its entirety:

-   -   International Patent Application Publication No. WO 2016/116753,        titled ROBOT TOOL RETRACTION, filed Jan. 21, 2016, which        published on Jul. 28, 2016;    -   U.S. Patent Application Publication No. 2016/0331482, titled        TORQUE SENSING IN A SURGICAL ROBOTIC WRIST, filed May 13, 2016,        which published on Nov. 17, 2016;    -   U.S. Patent Application Publication No. 2017/0021507, titled        DRIVE MECHANISMS FOR ROBOT ARMS, filed Jul. 22, 2016, which        published on Jan. 27, 2017;    -   U.S. Patent Application Publication No. 2017/0021508, titled        GEAR PACKAGING FOR ROBOTIC ARMS, filed Jul. 22, 2016, which        published on Jan. 27, 2017;    -   U.S. Patent Application Publication No. 2017/0165012, titled        GUIDING ENGAGEMENT OF A ROBOT ARM AND SURGICAL INSTRUMENT, filed        Dec. 9, 2016, which published on Jun. 15, 2017; and    -   U.S. Patent Application Publication No. 2017/0172553, titled        PULLEY ARRANGEMENT FOR ARTICULATING A SURGICAL INSTRUMENT, filed        Dec. 9, 2016, which published on Jun. 22, 2017.

In one instance, the robotic surgical systems and features disclosedherein can be employed with the VERSIUS® robotic surgical system and/orthe robotic surgical system of FIG. 265. The reader will furtherappreciate that various systems and/or features disclosed herein canalso be employed with alternative surgical systems including thecomputer-implemented interactive surgical system 100, thecomputer-implemented interactive surgical system 200, the roboticsurgical system 110, the robotic hub 122, the robotic hub 222, and/orthe robotic surgical system 15000, for example.

In various instances, a robotic surgical system can include a roboticcontrol tower, which can house the control unit of the system. Forexample, the control unit 14409 of the robotic surgical system depictedin FIG. 265 can be housed within a robotic control tower. The roboticcontrol tower can include a robot hub such as the robotic hub 122 (FIG.2) or the robotic hub 222 (FIG. 9), for example. Such a robotic hub caninclude a modular interface for coupling with one or more generators,such as an ultrasonic generator and/or a radio frequency generator,and/or one or more modules, such as an imaging module, a suction module,an irrigation module, a smoke evacuation module, and/or a communicationmodule, for example.

The reader will readily appreciate that the computer-implementedinteractive surgical system 100 (FIG. 1) and the computer-implementedinteractive surgical system 200 (FIG. 9) disclosed herein canincorporate the robotic arm 14400. Additionally or alternatively, therobotic surgical system depicted in FIG. 265 can include variousfeatures and/or components of the computer-implemented interactivesurgical systems 100 and 200.

A robotic hub can include a situational awareness module, which can beconfigured to synthesize data from multiple sources to determine anappropriate response to a surgical event. For example, a situationalawareness module can determine the type of surgical procedure, step inthe surgical procedure, type of tissue, and/or tissue characteristics,as further described herein. Moreover, such a module can recommend aparticular course of action or possible choices to the robotic systembased on the synthesized data. In various instances, a sensor systemencompassing a plurality of sensors distributed throughout the roboticsystem can provide data, images, and/or other information to thesituational awareness module. Such a situational awareness module can beincorporated into a control unit, such as the control unit 14409, forexample. In various instances, the situational awareness module canobtain data and/or information from a non-robotic surgical hub and/or acloud, such as the surgical hub 106, the surgical hub 206, the cloud104, and/or the cloud 204, for example. Situational awareness of asurgical system is further disclosed herein and in U.S. ProvisionalPatent Application Ser. No. 62/611,341, titled INTERACTIVE SURGICALPLATFORM, filed Dec. 28, 2017, and in U.S. Provisional PatentApplication Ser. No. 62/611,340, titled CLOUD-BASED MEDICAL ANALYTICS,filed Dec. 28, 2017, the disclosure of each of which is hereinincorporated by reference in its entirety.

Referring again to FIG. 265, the robotic arm 14400 does not include alinear slide mechanism for moving the attached surgical tool 14406 alonga longitudinal axis of the tool 14406. Rather, the limbs 14402 of thearm 14400 are configured to rotate about the various joints 14403 of thearm 14400 to move the surgical tool 14406. In other words, even movementof the surgical tool 14406 along the longitudinal axis A_(T) thereofrequires the articulation of various limbs 14402. For example, to movethe surgical tool 14406 along the longitudinal axis A_(T), the roboticarm 14400 would move at multiple revolute joints 14403 thereof. Ineffect, linear displacement of the tool 14406 for extending the endeffector through a trocar, retracting the end effector from the trocar,and/or for localized displacements of the surgical tool 14406 along thelongitudinal axis A_(T), such as during a suturing process, for example,would require the actuation of multiple revolute joints 14403 and thecorresponding movement of multiple rigid limb portions 14402 of the arm14400.

In instances in which a robotic surgical system lacks a linear slidemechanism, as described herein, intelligent sensing systems, additionalcommunication paths, and/or interactive displays can enable more precisecontrol of the robotic arm including the implementation of controlmotions that involve a linear displacement of the surgical tool along anaxis thereof. For example, to ensure the accurate positioning of thetool 14406 and to avoid inadvertent collisions within an operating room,it may be desirable to include additional systems in the robotic systemfor determining the position of a surgical tool 14406 and/or portions ofthe robotic arm 14400, for repositioning of the robotic arm 14400 fromwithin the sterile field, for communicating the position of the surgicaltool 14406 relative to the surgical site, for visualizing the surgicaltool 14406 at the surgical site, and/or for manipulating the surgicaltool 14406 around the surgical site, for example.

In one aspect, a robotic surgical system can include a primary controlmechanism for positioning the tool and a secondary means for directlyand/or independently measuring the position of the tool. In one aspect,a redundant or secondary sensing system can be configured to determineand/or verify a position of a robotic arm and/or a surgical toolattached to the robotic arm. The secondary sensing system can beindependent of a primary sensing system.

In one instance, the primary control mechanism can rely on closed-loopfeedback to calculate the position of the tool. For example, a controlunit of a robotic surgical system can issue control motions for therobotic arm, including the various motors and/or drivers thereof to moveportions of the robotic arm in a three-dimensional space, as furtherdescribed herein. Such a control unit can determine the position and/ororientation of the portions of the robotic arm based on torque sensorson the motors and/or displacement sensors on the drivers, for example.In such instances, the position of the surgical tool, the end effector,and/or components thereof can be determined by proximally-locatedsensors. The proximally-located sensors can be located in a proximalhousing or mounting portion of the tool and/or the robotic arm. In oneinstance, such proximally-located sensors can be positioned outside thesterile field, for example. The position of a surgical tool mounted to arobotic arm can be determined by measuring the angle(s) of each joint ofthe arm, for example. The control unit and sensors in communicationtherewith, which determine the position of the arm based on the controlmotions delivered thereto, can be considered a primary or first sensingsystem of the robotic surgical system.

In addition to a primary sensing system, as described herein, aredundant or secondary sensing system can be employed by the roboticsurgical system. The secondary sensing system can include one or moredistally-located sensors. The distally-located sensors can be positionedwithin the sterile field and/or on the end effector, for example. Thedistally-located sensors are distal to the proximally-located sensors ofthe primary sensing system, for example. In one instance, thedistally-located sensors can be “local” sensors because they are localto the sterile field and/or the surgical site, and theproximally-located sensors can be “remote” sensors because they areremote from the sterile field and/or the surgical site.

Referring now to FIG. 273, portions of a robotic surgical system 14300are schematically depicted. The robotic surgical system 14300 is similarin many respects to the robotic surgical system of FIG. 265. Forexample, the robotic surgical system 14300 includes a plurality ofmovable components 14302. In one aspect, the movable components 14302are rigid limbs that are mechanically coupled in series at revolutejoints. Such moveable components 14302 can form a robotic arm, similarto the robotic arm 14440 (FIG. 265), for example. The distal-mostcomponent 14302 includes an attachment for releasably attachinginterchangeable surgical tools, such as the surgical tool 14306, forexample. Each component 14302 of the robotic arm has one or more motors14307 and motor drivers 14314, which can be operated to affectrotational motion at the respective joint.

Each component 14302 includes one or more sensors 14308, which can beposition sensors and/or torque sensors, for example. The sensors 14308can provide information regarding the current configuration and/or loadat the respective joint between the components 14402. The motors 14307can be controlled by a control unit 14309, which is configured toreceive inputs from the sensors 14308 and/or from a surgical commandinterface, such as surgical command interface 14412 (FIG. 265), forexample.

A primary sensing system 14310 is incorporated into the control unit14309. In one aspect, the primary sensing system 14310 can be configuredto detect the position of one or more components 14302. For example, theprimary sensing system 14310 can include the sensors 14308 for themotors 14307 and/or the drivers 14314. Such sensors 14308 are remotefrom the patient P and located outside of the sterile field. Thoughlocated outside of the sterile field, the primary sensing system 14310can be configured to detect the position(s) of the component(s) 14302and/or the tool 14306 within the sterile field, such as at the positionof the distal end of the robotic arm and/or the attachment portionthereof. Based on the position of the robotic arm and components 14302thereof, the control unit 14309 can extrapolate the position of thesurgical tool 14306, for example.

The robotic surgical system 14300 of FIG. 273 also includes a secondarysensing system 14312 for directly tracking the position and/ororientation or various parts of the robotic surgical system 14300 and/orparts of an associated, non-robotic system such as handheld surgicalinstruments 14350. Referring still to FIG. 273, the secondary sensingsystem 14312 includes a magnetic field emitter 14320 that is configuredto emit a magnetic field in the vicinity of one or more magnetic sensorsto detect the positions thereof. Components 14302 of the robotic arminclude magnetic sensors 14322, which can be utilized to determineand/or verify the position of the respective components 14302. Themagnetic sensors 14322 are remote to the motors 14307 and the drivers14308, for example. In any event, the torque through the motor and/orthe displacement of a driver may not affect the output from the magneticsensors. Consequently, the sensing systems are independent.

In certain instances, the magnetic sensors 14322 can be positionedwithin the sterile field. For example, the surgical tool 14306 caninclude the magnetic sensor 14324, which can be utilized to determineand/or verify the position of the surgical tool 14306 attached to therobotic arm and/or to determine and/or verify the position of acomponent of the surgical tool 14306, such as a firing element, forexample. Additionally or alternatively, one or more patient sensors14326 can be positioned within the patient P to measure the patient'slocation and/or anatomic orientation. Additionally or alternatively, oneor more trocar sensors 14328 can be positioned on a trocar 14330 tomeasure the trocar's location and/or orientation, for example.

Referring again to the robotic arm 14400 depicted in FIG. 265, thesurgical tool 14406 is attached to the attachment portion 14405 at thedistal end of the robotic arm 14400. When the surgical tool 14406 ispositioned within a trocar, the robotic surgical system can establish avirtual pivot which can be fixed by the robotic surgical system, suchthat the arm 14400 and/or the surgical tool 14406 can be manipulatedthereabout to avoid and/or minimize the application of lateral forces tothe trocar. In certain instances, applying force(s) to the trocar maydamage the surrounding tissue, for example. Thus, to avoid inadvertentdamage to tissue, the robotic arm 14400 and/or the surgical tool 14406can be configured to move about the virtual pivot of the trocar withoutupsetting the position thereof and, thus, without upsetting thecorresponding position of the trocar. Even when applying a lineardisplacement of the surgical tool 14406 to enter or exit the trocar, thevirtual pivot can remain undisturbed.

In one aspect, the trocar sensor(s) 14328 in FIG. 273A can be positionedat a virtual pivot 14332 on the trocar 14330. In other instances, thetrocar sensors 14328 can be adjacent to the virtual pivot 14332.Placement of the trocar sensors 14328 at and/or adjacent to the virtualpivot 14332 thereof can track the position of the trocar 14330 andvirtual pivot 14332 and help to ensure that the trocar 14330 does notmove during displacement of the surgical tool 14306, for example. Insuch instances, without physically engaging or holding the trocar 14330,the robotic surgical system 14300 can confirm and/or maintain thelocation of the trocar 14330. For example, the secondary sensing system14312 can confirm the location of the virtual pivot 14332 of the trocar14330 and the surgical tool 14306 relative thereto.

Additionally or alternatively, one or more sensors 14352 can bepositioned on one or more handheld surgical instruments 14350, which canbe employed during a surgical procedure in combination with the surgicaltools 14306 utilized by the robotic surgical system 14300. The secondarysensing system 14312 is configured to detect the position and/ororientation of one or more handheld surgical instruments 14350 withinthe surgical field, for example, within the operating room and/orsterile field. Such handheld surgical instruments 14350 can includeautonomous control units, which may not be robotically controlled, forexample. As depicted in FIG. 273, the handheld surgical instruments14350 can include sensors 14352, which can be detected by the magneticfield emitter 14320, for example, such that the position and/or locationof the handheld surgical instruments 14350 can be ascertained by therobotic surgical system 14300. In other instances, components of thehandheld surgical instruments 14350 can provide a detectable output. Forexample, a motor and/or battery pack can be detectable by a sensor inthe operating room.

In one aspect, the magnetic field emitter 14320 can be incorporated intoa main robot tower. The sensors 14322, 14324, 14326, 14328, and/or 14352within the sterile field can reflect the magnetic field back to the mainrobot tower to identity the positions thereof. In various instances,data from the magnetic field emitter 14320 can be communicated to adisplay 14340, such that the position of the various components of thesurgical robot, surgical tool 14302, trocar 14330, patient P, and/orhandheld surgical instruments 14350 can be overlaid onto a real-timeview of the surgical site, such as views obtained by an endoscope at thesurgical site. For example, the display 14340 can be in signalcommunication with the control unit of the robotic surgical systemand/or with a robotic hub, such as the hub 106, robotic hub 122, the hub206, and/or the robot hub 222 (FIG. 9), for example.

In other instances, the magnetic field emitter 14320 can be external tothe robot control tower. For example, the magnetic field emitter 14320can be incorporated into a hub.

Similar to the secondary sensing system 14312, which includes themagnetic field emitter 14320, in certain instances, time-of-flightsensors can be positioned on one or more of the robot component(s)14302, the surgical tool(s) 14306, the patient P, the trocar(s) 14328,and/or the handheld surgical instrument(s) 14350 to provide an array ofdistances between the emitter and the reflector points. Suchtime-of-flight sensors can provide primary or secondary (e.g. redundant)sensing of the position of the robot component(s) 14302, the surgicaltool(s) 14306, the patient P, the trocar(s) 14328, and/or the handheldsurgical instrument(s) 14350, for example. In one instance, thetime-of-flight sensor(s) can employ an infrared light pulse to providedistance mapping and/or facilitate 3D imaging within the sterile field.

In one instance, the secondary sensing system 14312 can include aredundant sensing system that is configured to confirm the position ofthe robotic components and/or tools. Additionally or alternatively, thesecondary sensing system 14312 can be used to calibrate the primarysensing system 14310. Additionally or alternatively, the secondarysensing system 14312 can be configured to prevent inadvertententanglement and/or collisions between robotic arms and/or components ofa robotic surgical system.

Referring again to FIG. 273, in one instance, the components 14302 ofthe robotic surgical system 14300 can correspond to discrete roboticarms, such as the robotic arms 15024 in the robotic surgical system15000 (FIG. 22) and/or the robotic arms depicted in FIG. 2, for example.The secondary sensing system 14312 can be configured to detect theposition of the robotic arms and/or portions thereof as the multiplearms are manipulated around the surgical theater. In certain instances,as one or more arms are commanded to move towards a potential collision,the secondary sensing system 14312 can alert the surgeon via an alarmand/or an indication at the surgeon's console in order to prevent aninadvertent collision of the arms.

Referring now to FIG. 274, a flow chart for a robotic surgical system isdepicted. The flow chart can be utilized by the robotic surgical system14300 (FIG. 273), for example. In various instances, two independentsensing systems can be configured to detect the location and/ororientation of a surgical component, such as a portion of a robotic armand/or a surgical tool. The first sensing system, or primary sensingsystem, can rely on the torque and/or load sensors on the motors and/ormotor drivers of the robotic arm. The second sensing system, orsecondary sensing system, can rely on magnetic and/or time-of-flightsensors on the robotic arm and/or surgical tool. The first and secondsensing systems are configured to operate independently and in parallel.For example, at step 14502, the first sensing system determines thelocation and orientation of a robotic component and, at step 14504,communicates the detected location and orientation to a control unit.Concurrently, at step 14506, the second sensing system determines thelocation and orientation of the robotic component and, at step 14508,communicates the detected location and orientation to the control unit.

The independently-ascertained locations and orientations of the roboticcomponent are communicated to a central control unit at step 14510, suchas to the robotic control unit 14309 and/or a surgical hub. Uponcomparing the locations and/or orientations, the control motions for therobotic component can be optimized at step 14512. For example,discrepancies between the independently-determined positions can be usedto improve the accuracy and precision of control motions. In certaininstances, the control unit can calibrate the control motions based onthe feedback from the secondary sensing system. The data from theprimary and secondary sensing systems can be aggregated by a hub, suchas the hub 106 or the hub 206, for example, and/or data stored in acloud, such as the cloud 104 or the cloud 204, for example, to furtheroptimize the control motions of the robotic surgical system.

In certain instances, the robotic system 14300 can be in signalcommunication with a hub, such as the hub 106 of the hub 206, forexample. The hubs 106, 206 can include a situational awareness module,as further described herein. In one aspect, at least one of the firstsensor system 14310 and the second sensor system 14312 are data sourcesfor the situational awareness module. For example, the sensor systems14310 and 14312 can provide position data to the situational awarenessmodule. Further, the hub 106, 206 can be configured to optimize and/orcalibrate the control motions of the robotic arm 14300 and/or thesurgical tool 14306 based on the data from the sensor systems incombination with the situational awareness, for example. In one aspect,a sensing system, such as the secondary sensing system 14312 can informthe hub 106, 206 and situational awareness module thereof when ahandheld surgical instrument 14350 has entered the operating room orsurgical theater and/or when an end effector has been fired, forexample. Based on such information, the hub 106, 206 can determineand/or confirm the particular surgical procedure and/or step thereof.

The reader will appreciate that various independent and redundantsensing systems disclosed herein can be utilized by a robotic surgicalsystem to improve the accuracy of the control motions, especially whenmoving the surgical tool along a longitudinal axis without relying on alinear slide mechanism, for example.

In one aspect, the surgical hub includes a processor and a memorycommunicatively coupled to the processor, as described herein. Thememory stores instructions executable by the processor to detect aposition of a robotically-controlled component independent of a primarysensing system, as described above.

In various aspects, the present disclosure provides a control circuitconfigured to detect a position of a robotically-controlled componentindependent of a primary sensing system, as described above. In variousaspects, the present disclosure provides a non-transitory computerreadable medium storing computer readable instructions which, whenexecuted, cause a machine to detect a position of arobotically-controlled component independent of a primary sensingsystem, as described above.

In one aspect, a robotic surgical system can be configured to wirelesslycommunicate with one or more intelligent surgical tools mounted to arobotic arm thereof. The control unit of the robotic system cancommunicate with the one or more intelligent surgical tools via awireless connection, for example. Additionally or alternatively, therobotic surgical system can include a robotic hub, which can wirelesslycommunicate with the intelligent surgical tool(s) mounted to the roboticarm(s). In still other instances, a non-robotic surgical hub canwirelessly communicate with the intelligent surgical tool(s) mounted toa robotic arm. In certain instances, information and/or commands can beprovided to the intelligent surgical tool(s) from the control unit viathe wireless connection. For example, certain functions of a surgicaltool can be controlled via data received through a wirelesscommunication link on the surgical tool. Similarly, in one aspect,closed-loop feedback can be provided to the robotic surgical system viadata received via the wireless communication link to the surgical tool.

Referring primarily to FIGS. 270-272, a surgical tool 14206 is mountedto a robotic arm 14000 of a surgical robot. The robotic arm 14000 issimilar in many respects to the robotic arm 14400 in FIG. 265. Forexample, the arm 14000 includes a plurality of movable components 14002.In one aspect, the movable components 14002 are rigid limbs that aremechanically coupled in series at revolute joints 14003. Such moveablecomponents 14002 form the robotic arm 14400, similar to the arm 14400(FIG. 265), for example. A distal-most component 14002 c of the roboticarm 14400 includes an attachment 14005 for releasably attachinginterchangeable surgical tools, such as the surgical tool 14206. Eachcomponent 14002 of the arm 14000 has one or more motors and motordrivers, which can be operated to affect rotational motion at therespective joint 14003.

Each component 14002 includes one or more sensors, which can be positionsensors and/or torque sensors, for example, and can provide informationregarding the current configuration and/or load at the respective jointbetween the components 14002. The motors can be controlled by a controlunit, such as the control unit 14409 (FIG. 265), which is configured toreceive inputs from the sensors 14008 and/or from a command interface,such as the surgeon's command console 14412 (FIG. 265), for example.

The surgical tool 14206 is a linear stapler including a wirelesscommunication module 14208 (FIG. 271). The linear stapler can be anintelligent linear stapler and can include an intelligent fastenercartridge, an intelligent end effector, and/or an intelligent shaft, forexample. Intelligent surgical components can be configured to determinevarious tissue properties, for example. In one instance, one or moreadvanced end effector functions may be implemented based on the detectedtissue properties. A surgical end effector can include one or moresensors for determining tissue thickness, compression, and/or impedance,for example. Moreover, certain sensed parameters can indicate tissuevariations, such as the location of a tumor, for example. Intelligentsurgical devices for sensing various tissue properties are furtherdisclosed the following references:

-   -   U.S. Pat. No. 9,757,128, filed Sep. 5, 2014, titled MULTIPLE        SENSORS WITH ONE SENSOR AFFECTING A SECOND SENSOR'S OUTPUT OR        INTERPRETATION, which issued on Sep. 12, 2017;    -   U.S. patent application Ser. No. 14/640,935, titled OVERLAID        MULTI SENSOR RADIO FREQUENCY (RF) ELECTRODE SYSTEM TO MEASURE        TISSUE COMPRESSION, filed Mar. 6, 2015, now U.S. Patent        Application Publication No. 2016/0256071, which published on        Sep. 8, 2016;    -   U.S. patent application Ser. No. 15/382,238, titled MODULAR        BATTERY POWERED HANDHELD SURGICAL INSTRUMENT WITH SELECTIVE        APPLICATION OF ENERGY BASED ON TISSUE CHARACTERIZATION, filed        Dec. 16, 2016, now U.S. Patent Application Publication No.        2017/0202591, which published on Jul. 20, 2017; and    -   U.S. patent application Ser. No. 15/237,753, titled CONTROL OF        ADVANCEMENT RATE AND APPLICATION FORCE BASED ON MEASURED FORCES,        filed Aug. 16, 2016, now U.S. Patent Application Publication No.        2018/0049822, which published on Feb. 22, 2018;        each of which is herein incorporated by reference in its        entirety.

As depicted in FIG. 270, a wireless communication link 14210 is providedbetween the surgical tool 14206 and a hub 14212. The hub 14212 is asurgical hub, like the hub 106 or the hub 206, for example. In otherinstances, the hub 14212 can be a robotic hub, like the robotic hub 122or the robotic hub 222, for example. In FIG. 270, the wirelesscommunication module 14208 includes a wireless signal transmitter thatis located near the distal end of the end effector of the surgical tool14206. In other instances, the wireless transmitter can be positioned ona proximal portion of the end effector or on the shaft of the surgicaltool 14206.

The wireless communication link 14212 between the surgical tool 14206and the surgical hub 14212 provides real-time data transfer through asterile barrier 14230. Additionally or alternatively, the wirelesscommunication module 14208 can be configured to communicate with a robotcontrol tower and/or the control unit, which issues the control motionsto the robotic arm 14000 and actuations to the surgical tool 14206 basedon inputs at the surgeon's command console. In certain instances, thecontrol unit for the robotic arm 14000 can be incorporated into thesurgical hub 14212 and/or a robotic hub, such as the robotic hub 122(FIG. 2) or the robotic hub 222 (FIG. 9), for example.

In certain instances, it can be difficult to confirm the position of thesurgical tool 14206 within the surgical theater, around the surgicalsite, and/or relative to the targeted tissue. For example, lateraldisplacement of the surgical tool 14206 can be constrained by a physicalboundary, such as a longitudinally-extending trocar, for example. Insuch instances, lateral displacement of the surgical tool 14206 can bedetermined by a resistance force from and/or on the trocar. Conversely,linear displacement of the surgical tool 14206 can be unconstrained byphysical boundaries of the surgical system. In such instances, when thecontrol unit directs linear displacement of the surgical tool 14206 or aportion thereof, and the various movable links 14002 and joints 14003articulate to affect the linear displacement, it can be difficult todetermine and/or confirm the position of the surgical tool 14206 andrespective portions thereof.

When the surgical tool 14206 is moved along the longitudinal axis of thetool A_(T) (FIG. 271), which is collinear with the shaft of the surgicaltool 14206, it can be difficult to determine and/or confirm the exactposition of the surgical tool 14206. In certain instances, as providedherein, the robotic surgical system can include a secondary sensingsystem, which is configured to detect the position of the surgical tool14206. For example, the wireless communication module 14208 can be insignal communication with a secondary sensing system, such as thesecondary sensing system 14312 (FIG. 273) and/or a sensor thereof.Moreover, the wireless communication module 14208 can communicate theposition of the surgical tool 14206, as detected by the secondarysensing system 14312, to the surgical hub 14212 via the wirelesscommunication link 14210. Additionally or alternatively, the wirelesscommunication module 14208 can communicate information from the varioussensors and/or systems of the intelligent surgical tool 14206 to thesurgical hub 14212. The surgical hub 14212 can disseminate theinformation to displays within the operating room or external displays,to a cloud, and/or to one or more hubs and/or control units used inconnection with the surgical procedure.

Referring primarily to FIG. 271, in one instance, the surgical tool14206 can be employed to remove a cancerous tumor 14242 from patienttissue T. To ensure complete removal of the tumor 14242 while minimizingthe removal of healthy tissue, a predefined margin zone 14240 can bedefined around the tumor 14242. The margin zone can be determined by thesurgeon based on patient data, aggregated data from a hub and/or acloud, and/or data sensed by one or more intelligent components of thesurgical system, for example. During the operation, the surgical tool14206 can transect the tissue T along the margin zone 14240 such thatthe margin zone 14240 is removed along with the tumor 14242. The primaryand secondary sensing systems 14310 and 14312 (FIG. 273) can determinethe position of the surgical tool 14206 relative to the margin zone, forexample. Moreover, the wireless communication module 14208 cancommunicate the detected position(s) to the control unit.

In certain instances, the robotic system of FIGS. 271 and 272 can beconfigured to actuate (e.g. fire) the surgical tool 14206 when thesurgical tool 14206 moves within the margin zone 14240. For example,referring primarily to FIG. 272, a graphical display 14250 of distanceand force-to-close over time for the linear stapler 14206 during thesurgical procedure of FIG. 270 is depicted. As the surgical tool 14206approaches the margin zone 14240 at time t₁, the force-to-close (FTC)increases indicating that the surgical tool 14206 is being clamped ontissue T around the tumor 14242 between time t₁ and time t₂. Morespecifically, the surgical tool 14206 is clamped when moved intoposition a distance between distances D₁ and D₂. The distance D₁ canrefer to the outer boundary of the margin zone 14240 around the tumor14242, for example, and the distance D₂ can refer to the inner boundaryof the margin zone 14240, which can be assumed boundary of the tumor14242, for example.

In various instances, the control unit and the processor thereof canautomatically affect the clamping motion when the surgical tool 14206 ispositioned at the appropriate distance based on input from a primarysensing system and/or a secondary sensing system. In other instances,the control unit and the processor thereof can automatically alert thesurgeon that the surgical tool 14206 is positioned at the appropriatedistance. Similarly, in certain instances, the processor canautomatically fire the surgical tool 14206 and/or suggest to the surgeonthat the surgical tool 14206 be fired based on the detected position(s)of the surgical tool 14206. The reader will readily appreciate thatother actuation motions are envisioned, such as energizing an energytool and/or articulating and articulatable end effector, for example.

In certain instances, the hub 14212 can include a situational awarenesssystem, as further described herein. In one aspect, the position of thetumor 14242 and/or the margin zone 14240 therearound can be determinedby the situational awareness system or module of the hub 14212. Incertain instances, the wireless communication module 14208 can be insignal communication with the situational awareness module of the hub14212. For example, referring again to FIG. 86, the stapler data and/orthe cartridge data provided at steps 5220 and 5222 can be provided viathe wireless communication module 14208 of the stapling tool 14206, forexample.

In one aspect, sensors positioned on the surgical tool 14206 can beutilized to determine and/or confirm the position of the surgical tool14206 (i.e. a secondary sensing system). Moreover, the detected positionof the linear stapler can be communicated to the surgical hub 14212across the wireless communication link 14210, as further describedherein. In such instances, the surgical hub 14212 can obtain real-time,or near real-time, information regarding the position of the surgicaltool 14206 relative to the tumor 14242 and the margin zone 14240 basedon the data communicated via the wireless communication link 14230. Invarious instances, the robotic surgical system can also determine theposition of the surgical tool 14206 based on the motor controlalgorithms utilized to position the robotic arm 14000 around thesurgical theater (i.e. a primary sensing system).

In one aspect, a robotic surgical system can integrate with an imagingsystem. Real-time feeds from the surgical site, which are obtained bythe imaging system, can be communicated to the robotic surgical system.For example, referring again to FIGS. 2 and 3, real-time feeds from theimaging module 138 in the hub 106 can be communicated to the roboticsurgical system 110. For example, the real-time feeds can becommunicated to the robotic hub 122. In various instances, the real-timefeed can be overlaid onto one or more active robot displays, such as thefeeds at the surgeon's command console 118. Overlaid images can beprovided to one or more displays within the surgical theater, such asthe displays 107, 109, and 119, for example.

In certain instances, the overlay of real-time feeds onto a robotdisplay can enable the surgical tools to be precisely controlled withinan axes system that is defined by the surgical tool and/or the endeffector(s) thereof as visualized by the real-time imaging system. Invarious instances, cooperating between the robotic surgical system 110and the imaging system 138 can provide triangulation and instrumentmapping of the surgical tools within the visualization field, which canenable precise control of the tool angles and/or advancements thereof.Moreover, shifting control from a standard multi-axes, fixed Cartesiancoordinate system to the axis defined by the currently-mounted tooland/or to the end effector thereof can enable the surgeon to issuecommands along clear planes and/or axes. For example, a processor of therobotic surgical system can direct a displacement of a surgical toolalong the axis of the elongate shaft of the surgical tool or a rotationof the surgical tool at a specific angle from the current position basedon a selected point to rotate about. In one exemplification, theoverlaid feed of a surgical tool can incorporate a secondary orredundant sensing system, as further described herein, to determine thelocation and/or orientation of the surgical tool.

In certain instances, a robotic arm, such as the robotic arm 14400 (FIG.265) can be significantly heavy. For example, the weight of a roboticarm can be such that manually lifting or repositioning the robotic armis difficult for most able-bodied clinicians. Moreover, the motors anddrive mechanisms of the robotic arm may only be controlled by a primarycontrol system located at the control unit based on inputs from thesurgeon's command console. Stated differently, a robotic surgicalsystem, such as the system depicted in FIG. 265, for example, may notinclude a secondary control system for the robotic arm 14400 that islocal to the robotic arm 14400 and within the sterile field.

A robotic arm in a robotic surgical system may be prone to inadvertentcollisions with equipment and/or people within the sterile field. Forexample, during a surgical procedure, surgeon(s), nurse(s), and/ormedical assistant(s) positioned within the sterile field may move aroundthe sterile field and/or around the robotic arms. In certain instances,the surgeon(s), nurse(s), and/or medical assistant(s), for example, mayreposition equipment within the sterile field, such as tables and/orcarts, for example. When a surgeon positioned outside of the sterilefield is controlling the robotic arm, another surgeon, nurse, and/ormedical assistant positioned within the sterile field may also want tomanually move and/or adjust the position of one of more robotic arms inorder to avoid a potential collision with the arm(s), entanglement ofthe arm with other equipment and/or other arms, and/or to replace,reload, and/or reconfigure a surgical tool mounted to the arm. However,to reposition the robotic arm, the surgeon may need to power down therobotic surgical system to enable the clinician within the sterile fieldto manually reposition the robotic arm. In such instances, the cliniciancan be required to carry the significant weight of the unpowered, orpowered down, robotic arm.

In one instance, a robotic surgical system can include an interactivedisplay that is local to the sterile field and/or local to the roboticarm(s). Such a local display can facilitate manipulation and/orpositioning of the arm(s) by a clinician within the sterile field.Stated differently, an operator other than the surgeon at the commandconsole can control the position of the robotic arm(s).

Referring now to FIG. 266, a clinician is applying a force to therobotic arm 14000 to manually adjust the position of the robotic arm14000. In certain instances, the robotic surgical system employing therobotic arm 14000 can employ a passive power assist mode, in which therobotic arm 14400 can easily be repositioned by a clinician within thesterile field. For example, though the robotic arm 14000 is powered andis controlled by a remote control unit, the clinician can manuallyadjust the position of the robotic arm 14000 without requiring theclinician to carry the entire weight of the robotic arm 14000. Theclinician can pull and/or push the robotic arm 14000 to adjust theposition thereof. In the passive power assist mode, the power to therobotic arm 14000 can be constrained and/or limited to permit thepassive repositioning by the clinician.

Referring now to FIG. 267, a graphical display 14050 of force over timeof the robotic arm 14000 (FIG. 266) in a passive power assist mode isdepicted. In the passive power assist mode, a clinician can apply amanual force to the robotic arm 14000 to initiate the repositioning ofthe robotic arm 14000. The clinician can be within the sterile field. Incertain instances, the passive power assist mode can be activated whenthe robotic arm 14000 senses a manual manipulation.

As depicted in FIG. 267, the manual force exerted by a clinician canincrease to exceed a predefined threshold, such as the 15-lb limitindicated in FIG. 267, for example, to affect repositioning of therobotic arm 14000. In certain instances, the predefined threshold cancorrespond to the maximum force an able-bodied assist can easily exerton the robotic arm 14000 without undue stress or strain. In otherinstances, the predefined threshold can correspond to a minimumthreshold force on the robotic arm 14000 in order to avoid providing apowered assist to unintentional or inadvertent contacts with the roboticarm 14000.

When the user exerts a force on the robotic arm 14000 above thepredefined threshold, one or more motors (e.g. motors 14407 in FIG. 265)of the robotic surgical system can apply an assisting force to therobotic arm 14000 to help reposition the robotic arm 14000 in thedirection indicated by the operator's force on the robotic arm 14000. Insuch instances, the operator can easily manipulate the position of thearm to avoid inadvertent collisions and/or entanglements and, when theoperator's force exceeds a comfortable threshold force, the motors canassist or cooperate in the repositioning of the arm. The passive powerassist provided by the motors of the robotic surgical system cancompensate for the weight of the robotic arm 14000. In other instances,the assisting force can be less than the weight of the robotic arm14000. In certain instances, the assisting force can be capped at amaximum force, such as the 5-lb limit indicated in FIG. 267, forexample. Capping the assisting force may ensure that the robotic arm14000 does not forcefully collide with a person, surgical equipment,and/or another robotic arm in the surgical theater.

In one aspect, the passive power assist mode can be deactivated orlocked out during portions of a surgical procedure. For example, when asurgical tool is positioned at the surgical site or within a predefinedradius of the surgical site and/or the target tissue, the passive powerassist mode can be locked out. Additionally or alternatively, duringcertain steps of a surgical procedure the passive power assist mode canbe locked out. Situational awareness can be configured to determinewhether the passive power assist mode should be locked out. For example,based on information that a hub knows regarding the step of the surgicalprocedure (see, e.g. FIG. 86), a passive power assist mode may beill-advised by the situational awareness module. Similarly, the passivepower assist mode can be activated during certain portions of thesurgical timeline shown in FIG. 86.

In one aspect, the control unit for operating a robotic arm includes aprocessor and a memory communicatively coupled to the processor, asdescribed herein. The memory stores instructions executable by theprocessor to operate in a passive power assist mode in which theprocessor is configured to process a manual force applied to the roboticarm and, if the manual force exceeds a predefined threshold, to directone or more motors of the robotic arm to provide an assisting force toreposition the robotic arm in the direction indicated by the manualforce.

In various aspects, the present disclosure provides a control circuitconfigured to operate a passive power assist mode, as described above.In various aspects, the present disclosure provides a non-transitorycomputer readable medium storing computer readable instructions which,when executed, cause a machine to operate a passive power assist mode,as described above.

Referring now to FIGS. 268 and 269, a clinician within the sterile fieldis utilizing a local control module 14160 within a sterile field toaffect repositioning of a robotic arm 14100. The robotic arm 14100 issimilar in many respects to the robotic arm 14400 in FIG. 265. Forexample, the robotic arm 14100 includes a plurality of movablecomponents 14102. The movable components 14102 are rigid limbs that aremechanically coupled in series at revolute joints 14103. The moveablecomponents 14102 form the robotic arm 14100, similar to the robotic arm14400 (FIG. 265), for example. A distal-most component 14102 c includesan attachment 14105 for releasably attaching interchangeable surgicaltools, such as the surgical tool 14106, for example. Each component14102 of the robotic arm 14100 has one or more motors and motor drivers,which can be operated to affect rotational motion at the respectivejoint 14103.

Each component 14102 includes one or more sensors, which can be positionsensors and/or torque sensors, for example, and can provide informationregarding the current configuration and/or load at the respective jointbetween the components 14102. The motors can be controlled by a controlunit, such as the control unit 14409 (FIG. 265), which is configured toreceive inputs from the sensors and/or from a surgical commandinterface, such as the surgical command interface 14412 (FIG. 265), forexample.

The local control module 14160 includes an interactive display 14164 anda touch screen 14166 that is configured to accept inputs, such as inputsfrom a finger and/or a stylus 14168, for example. The local controlmodule 14160 is a handheld, mobile digital electronic device. Forexample, the local control module 14160 can be an iPad® tablet or othermobile tablet or smart phone, for example. In use, the clinicianprovides repositioning instructions to the robotic arm 14100 via thedisplay 14164 and/or the touch screen 14166 of the local control module14160. The local control module 14160 is a wireless communication module14162 such that the inputs from the clinician can be communicated to therobotic arm 14140 to affect arm control motions. The local controlmodule 14140 can wirelessly communicate with the robotic arm 14140and/or a control unit (e.g. the control unit 14409 in FIG. 265) of therobotic system via a Wi-Fi connection, for example.

The robotic arm 14100 includes six degrees of freedom indicated by thesix arrows in FIG. 268. The proximal degrees of freedom can becontrolled by the local control module 14160 and the distal degrees offreedom can be controlled by the remote control module. In one instance,the three most-proximal degrees of freedom (articulation about the twomost-proximal joints 14103 and rotation of the intermediate limb 14102about the axis thereof) can be controlled by the local control moduleand the three most-distal degrees of freedom (articulation about themost-distal joint 14103, rotation of the most-distal limb 14102 c aboutthe axis thereof, and displacement of the surgical tool 14106 along theaxis thereof) can be controlled by the remote control module. In suchinstances, the clinician within the sterile field can affect grossrobotic arm control motions, such as control motions of the proximalarms and/or joints. For example, the clinician within the sterile fieldcan quickly and easily move a robotic arm to a general position, such asa pre-operative position, tool exchanging position, and/or reloadingposition via the local control module 14160. In such instances, thelocal control module 14160 is a secondary control system for the roboticarm 14100. The surgeon outside the sterile field can affect morelocalized or finessed robotic arm control motions via inputs at thesurgeon's command interface 14412 (FIG. 265). In such instances, thesurgeon's command interface 14412 outside the sterile field is theprimary control system.

The reader will readily appreciate that fewer or greater than sixdegrees of freedom are contemplated. Alternative degrees of freedom arealso contemplated. Moreover, different degrees of freedom can beassigned to the local control module 14160 and/or the remote controlmodule. In certain instances, one or more degrees of freedom can beassigned to both the local control module 14106 and the remote controlmodule.

Referring primarily now to FIG. 269, a graphical display 14150 of forceover time of the robotic arm 14100 is depicted. From time 0 to time t₁,locally-actuated, in-field forces are applied to the robotic arm 14100by a clinician within the sterile field to adjust the general positionof the robotic arm 14100. In certain instances, the force attributableto inputs from the local control module 14160 can be capped at a firstmaximum force (for example the 50-lb limit indicated in FIG. 269). Byutilizing the local control module 14160, the clinician within thesterile field can quickly reposition the robotic arm 14100 to exchangeand/or reload the surgical tool 14160, for example. Time 0 to time t₁can correspond to a local actuation mode. Active setup or reloading timein a surgical procedure can occur during the local actuation mode. Forexample, during the local actuation mode, the robotic arm 14100 can beout of contact with patient tissue and/or outside a predefined boundaryaround the surgical site, for example.

Thereafter, the surgeon at the surgeon's command console can furtheractuate the robotic arm 14100. For example, from time t₂ to time t₃, theremotely-actuated forces are attributable to inputs from the surgeon'scommand console. The remotely-actuated forces can be capped at a secondmaximum force (for example the 5-lb limit indicated in FIG. 269), whichis less than the first maximum force. By limiting the second maximumforce, a surgeon is less likely to cause a high-force or high-speedcollision within the sterile field while the larger first maximum forceallows the robotic arm 14100 to be quickly repositioned in certaininstances. Time t₂ to time t₃ can correspond to a remote actuation modeduring a surgical procedure, which can include when the robotic tool14106 is actively manipulating tissue (grasping, pulling, holding,transecting, sealing, etc.) and/or when the robotic arm 14100 and/orsurgical tool 14106 thereof is within the predefined boundary around thesurgical site.

In one aspect, the local actuation mode and/or the remote actuation modecan be deactivated or locked out during portions of a surgicalprocedure. For example, the local actuation mode can be locked out whenthe surgical tool is engaged with tissue or otherwise positioned at thesurgical site. Situational awareness can be configured to determinewhether the local actuation mode should be locked out. For example,based on information that a hub knows regarding the step of the surgicalprocedure (see, e.g. FIG. 86), a local actuation mode may be ill-advisedby the situational awareness module. Similarly, the remote actuationmode may be ill-advised during other portions of the surgical procedure.

In one aspect, the control unit for operating a robotic arm includes aprocessor and a memory communicatively coupled to the processor, asdescribed herein. The memory stores instructions executable by theprocessor to provide control motions to the robotic arm based on inputfrom a local control module during portion(s) of a surgical procedureand to provide control motions to the robotic arm based on input from aremote control module during portion(s) of the surgical procedure. Afirst maximum force can limit the control motions from the local controlmodule and a second maximum force can limit the control motions from theremote control module.

In various aspects, the present disclosure provides a control circuitconfigured to operate a robotic arm via a local control module and aremote control module, as described above. In various aspects, thepresent disclosure provides a non-transitory computer readable mediumstoring computer readable instructions which, when executed, cause amachine to operate a robotic arm via a local control module and a remotecontrol module, as described above.

The entire disclosures of:

-   -   U.S. Pat. No. 9,072,535, filed May 27, 2011, titled SURGICAL        STAPLING INSTRUMENTS WITH ROTATABLE STAPLE DEPLOYMENT        ARRANGEMENTS, which issued Jul. 7, 2015;    -   U.S. Pat. No. 9,072,536, filed Jun. 28, 2012, titled        DIFFERENTIAL LOCKING ARRANGEMENTS FOR ROTARY POWERED SURGICAL        INSTRUMENTS, which issued Jul. 7, 2015;    -   U.S. Pat. No. 9,204,879, filed Jun. 28, 2012, titled FLEXIBLE        DRIVE MEMBER, which issued on Dec. 8, 2015;    -   U.S. Pat. No. 9,561,038, filed Jun. 28, 2012, titled        INTERCHANGEABLE CLIP APPLIER, which issued on Feb. 7, 2017;    -   U.S. Pat. No. 9,757,128, filed Sep. 5, 2014, titled MULTIPLE        SENSORS WITH ONE SENSOR AFFECTING A SECOND SENSOR'S OUTPUT OR        INTERPRETATION, which issued on Sep. 12, 2017;    -   U.S. patent application Ser. No. 14/640,935, titled OVERLAID        MULTI SENSOR RADIO FREQUENCY (RF) ELECTRODE SYSTEM TO MEASURE        TISSUE COMPRESSION, filed Mar. 6, 2015, now U.S. Patent        Application Publication No. 2016/0256071;    -   U.S. patent application Ser. No. 15/382,238, titled MODULAR        BATTERY POWERED HANDHELD SURGICAL INSTRUMENT WITH SELECTIVE        APPLICATION OF ENERGY BASED ON TISSUE CHARACTERIZATION, filed        Dec. 16, 2016, now U.S. Patent Application Publication No.        2017/0202591; and    -   U.S. patent application Ser. No. 15/237,753, titled CONTROL OF        ADVANCEMENT RATE AND APPLICATION FORCE BASED ON MEASURED FORCES,        filed Aug. 16, 2016, now U.S. Patent Application Publication No.        2018/0049822;        are herein incorporated by reference in their respective        entireties.

During various surgical procedures, a surgeon, or other clinician, mayapply a clip to a patient's tissue in order to achieve various effectsand/or therapeutic results. Referring to FIG. 275, a surgicalinstrument, such as a clip applier 100, for example, can be configuredto apply one or more clips to tissue located within a surgical site inthe patient. Generally, referring now to FIG. 287, the clip applier 100can be structured and arranged to position a clip 140 relative to thetissue in order to compress the tissue within the clip 140. The clipapplier 100 can be configured to deform the clip 140 as illustrated inFIGS. 277 and 278, for example, and as described in greater detailfurther below. Each clip 140 can comprise a base 142 and opposing legs144 extending from the base 142. The base 142 and the legs 144 cancomprise any suitable shape and can define a substantially U-shapedconfiguration and/or a substantially V-shaped configuration, forexample. The base 142 can comprise angled portions 141 which areconnected together by a joint 143. In use, the legs 144 of the clip 140can be positioned on opposite sides of the tissue wherein the legs 144can be pushed toward one another to compress the tissue positionedbetween the legs 144. The joint 143 can be configured to permit theangled portions 141 of the base 142, and the legs 144 extendingtherefrom, to deform inwardly. In various circumstances, the clip 140can be configured to yield, or deform plastically, when the clip 140 issufficiently compressed, although some amount of elastic deformation, orspring-back, may occur within the deformed clip 140.

Referring now to FIGS. 275 and 276, the clip applier 100 can include ashaft 110, an end effector 120, and a replaceable clip cartridge, ormagazine, 130. Referring to FIGS. 288-290, the clip cartridge 130 cancomprise a housing 132 and a plurality of clips 140 positioned withinthe housing 132. The housing 132 can define a storage chamber 134 inwhich the clips 140 can be stacked. The storage chamber 134 can comprisesidewalls which extend around, or at least substantially around, theperimeter of the clips 140. Referring again to FIG. 287, each clip 140can comprise opposing faces, such as a top face 145 and a bottom face146 on opposite sides of the clip 140 wherein, when the clips 140 arestacked in the housing 132, the top face 145 of a clip 140 can bepositioned against the bottom face 146 of an adjacent clip 140 andwherein the bottom face 146 of the clip 140 can be positioned againstthe top face 145 of another adjacent clip 140. In various circumstances,the bottom faces 146 of the clips 140 can face downwardly toward one ormore support shelves, or platforms, 135 defined in the housing 132 whilethe top faces 145 of the clips 140 can face upwardly away from thesupport shelves 135. The top faces 145 and the bottom faces 146 of theclips 140 may be identical, or at least substantially identical, in somecases, while, in other cases, the top faces 145 and the bottom faces 146may be different. The stack of clips 140 depicted in FIGS. 288-290comprises five clips 140, for example; however, other embodiments areenvisioned in which the stack of clips 140 can include more than fiveclips 140 or less than five clips 140. In any event, the clip cartridge130 can further comprise at least one biasing member, such as biasingmember 136, for example, positioned intermediate the housing 132 and thetop clip 140 in the stack of clips 140. As described in greater detailbelow, the biasing member 136 can be configured to bias the bottom clip140 in the stack of clips 140 or, more particularly, the bottom face 146of the bottom clip 140, against the support shelves 135 defined in thehousing 132. The biasing member 136 can comprise a spring, and/or anysuitable compressed elastic element, for example, which can beconfigured to apply a biasing force to the clips 140, or at least applya biasing force to the top clip 140 which is transmitted downwardlythrough the stack of clips 140.

When a clip 140 is positioned against the support shelves 135 asdescribed above, the clip 140 can be supported in a firing position inwhich the clip 140 can be advanced and ejected from the cartridge 130.In various circumstances, the support shelves 135 can define at least aportion of a firing chamber 149 in which the clips 140 can besequentially positioned in the firing position. In some cases, thefiring chamber 149 can be entirely defined within the cartridge 130 or,in other cases, the firing chamber 149 can be defined within and/orbetween the shaft 110 and the cartridge 130. In any event, as describedin greater detail further below, the clip applier 100 can comprise afiring drive which can advance a firing member into the cartridge 130and push the clip 140 from its firing position positioned against thesupport shelves 135 to a fired position in which it is received withinthe end effector 120 of the clip applier 100. Referring primarily toFIGS. 288-290, the housing 132 of the cartridge 130 can comprise aproximal opening, or window, 133 which can be aligned, or at leastsubstantially aligned, with the support shelves 135 such that the firingmember can enter into the cartridge 130 through the proximal opening 133and advance a clip 140 distally out of the cartridge 130. In at leastone such embodiment, the housing 132 can further comprise a distal, ordischarge, opening, or window, 137 which is also aligned with thesupport shelves 135 such that the clip 140 can be advanced, or fired,distally along a firing axis 139 extending through the proximal opening133, the firing chamber 149, and the distal opening 137, for example.

In order to advance a clip 140 out of the cartridge 130, further to theabove, the firing member of the firing drive can be advanced into to thecartridge housing 132 and, in various circumstances, into the firingchamber 149. As disclosed in greater detail further below, the firingmember can pass entirely through the cartridge 130 in order to advancethe clip 140 into its fired position within the end effector 120. Afterthe clip 140 positioned in the firing chamber 149 has been advanceddistally by the firing member, as outlined above, the firing member canbe retracted sufficiently such that the biasing member 136 can positionanother clip 140 against the support shelves 135. In variouscircumstances, the biasing member 136 can bias a clip 140 against thefiring member while the firing member is positioned within the housing132. Such a clip 140 can be referred to as a queued clip. After thefiring member has been sufficiently retracted and slid out fromunderneath the queued clip 140, the biasing member 136 can then bias theclip 140 against the support shelves 135 where it is staged for the nextstroke of the reciprocating firing member. Referring primarily to FIGS.276 and 288-290, the cartridge 130 can be configured to supply the clips140 to the firing chamber 149 along a predetermined path, such as supplyaxis 138, for example. The supply axis 138 can be transverse to thefiring axis 139 such that the clips 140 are fed into the firing chamber149 in a direction which is different than the direction in which thefiring member passes through the firing chamber 149. In at least onesuch embodiment, the supply axis 138 can be perpendicular, or at leastsubstantially perpendicular, to the firing axis 139, for example.

Referring again to FIG. 276, the shaft 110 can comprise a cartridge, ormagazine, aperture 131 which can be sized and configured to receive aclip cartridge 130, for example, therein. The cartridge aperture 131 canbe sized and configured such that the housing 132 of the cartridge 130is closely received within the cartridge aperture 131. The sidewallswhich define the cartridge aperture 131 can limit, or at leastsubstantially limit, the lateral movement of the cartridge 130 relativeto the shaft 110. The shaft 110 and/or the cartridge 130 can furthercomprise one or more locks which can be configured to releasably holdthe cartridge 130 in the cartridge aperture 131. As illustrated in FIG.276, the cartridge 130 can be loaded into the cartridge aperture 131along an axis which is, in at least one embodiment, parallel to orcollinear with the supply axis 138. As also illustrated in FIG. 276, theshaft 110 can further comprise a pad or seat 118 extending from thesidewall 111 of the shaft 110 wherein the pad 118 can be configured tobe received within and/or engaged with the housing 132 of the cartridge130. The pad 118 can be sized and configured to be closely receivedwithin a recess 148 defined in the cartridge housing such that the pad118 can limit, or at least substantially limit, the lateral movement ofthe cartridge 130 relative to the shaft 110. The pad 118 can be sizedand configured to align the cartridge 130 within the shaft 110 and/orsupport the cartridge housing 132.

Once the clip cartridge 130 has been positioned and seated within theshaft aperture 131, referring now to FIGS. 279 and 280, a firing drive160 of the clip applier 100 can be actuated to advance the clips 140from the clip cartridge 130 as described above. The firing drive 160 cancomprise a rotary drive input such as a drive screw 161, for example,and a displaceable firing nut 163 operably engaged with the drive screw161. The drive screw 161 can comprise at least one drive thread 162which can be threadably engaged with a threaded aperture extendingthrough the firing nut 163. In various embodiments, the clip applier 100can further include an electric motor, for example, operably coupledwith the drive screw 161. In various instances, the drive screw 161 canbe operably coupled with the motor of a surgical instrument systemcomprising a hand-held instrument or a robotic arm, for example. In anyevent, the movement of the firing nut 163 within the shaft 110 can beconstrained such that the firing nut 163 moves along a longitudinal axis164 when the drive screw 161 is rotated about the longitudinal axis 164by the motor. For instance, when the drive screw 161 is rotated in afirst direction by the motor, the drive screw 161 can advance the firingnut 163 distally toward the end effector 120, as illustrated in FIG.280. When the drive screw 161 is rotated in a direction opposite thefirst direction by the motor, the drive screw 161 can retract the firingnut 163 proximally away from the end effector 120. The shaft 110 cancomprise one or more bearings which can be configured to rotatablysupport the drive screw 161. For instance, a bearing 159 can beconfigured to rotatably support the distal end of the drive screw 161,for example, as illustrated in FIGS. 279 and 280.

The firing drive 160 can further comprise a firing member 165 extendingfrom the firing nut 163 which can be advanced distally and retractedproximally with the firing nut 163, as described in greater detailfurther below. Upon comparing FIGS. 279 and 280, the reader will notethat the firing nut 163 and the firing member 165 have been advancedfrom a proximal, unfired position, illustrated in FIG. 279, to a distal,fired position, illustrated in FIG. 280, in which the firing member 165has advanced a clip 140 from the clip cartridge 130 into the endeffector 120. Referring primarily to FIG. 279, the clip cartridge 130 isillustrated as comprising a plurality of clips 140 stored thereinwherein one of the clips 140 is positioned in a firing position, asdescribed above. As illustrated in FIGS. 279 and 280, the firing member165 can include a distal portion 166 which can be advanced into thestaple cartridge 130 along a firing axis 167 and engage the clip 140positioned in the firing position when the firing member 165 and thefiring nut 163 are advanced distally. In some cases, the firing member165 can comprise a linear member while, in other cases, the distal end166 of the firing member 165 can extend upwardly from the firing member165, for example. Further to the above, the firing member 165 canadvance the clip 140 distally out of the clip cartridge 130 along thefiring axis 167 and into a receiving cavity 122 defined in the endeffector 120.

In various cases, the firing member 165 can be attached to and extenddistally from the firing nut 163 while, in other cases, the firingmember 165 and the firing nut 163 can be operably connected to oneanother by a firing actuator 168. The firing actuator 168 can bepivotably mounted to the firing member 165 at a pivot 169 and caninclude a distal arm 170 a and a proximal arm 170 b which can be engagedwith a longitudinal slot 113 defined in the housing 112 of the shaft110. In at least one such embodiment, each of the arms 170 a, 170 b caninclude a projection, such as projections 171 a and 171 b, respectively,extending therefrom which can be configured to slide within thelongitudinal slot 113. Further to the above, the firing nut 163 canfurther include a firing pin 172 extending therefrom which can beconfigured to engage the distal arm 170 a in order to advance theactuator 168 and the firing member 165 distally, as described above. Inuse, referring again to the progression illustrated in FIGS. 279 and280, the firing nut 163 can be advanced distally by the drive screw 161wherein the firing pin 172, which is positioned intermediate the distalarm 170 a and the proximal arm 170 b, can contact the distal arm 170 aand drive the actuator 168 and the firing member 165 distally. As theactuator 168 is advanced distally, the actuator 168 may be preventedfrom rotating about the pivot pin 169 as one or both of the projections171 a and 171 b sliding in the shaft slot 113 can be prevented frombeing moved laterally relative to the longitudinal shaft slot 113 untilthe actuator 168 reaches the position illustrated in FIG. 280.

When the actuator 168 has reached the position illustrated in FIG. 280,the distal projection 171 a can enter into a distal slot portion 114 ofthe longitudinal slot 113 which can be configured to pivot the actuator168 downwardly, or permit the actuator 168 to be pivoted downwardly, asillustrated in FIG. 283. In at least one such embodiment, the distalprojection 171 a can come into contact with the sidewall of the distalslot portion 114 which can guide the distal projection 171 a downwardlyand pivot the actuator 168 about the pivot 169 as the actuator 168 isadvanced forward by the firing nut 163. In such a pivoted position, thefiring pin 172 extending from the firing nut 163 may no longer beengaged with the distal arm 170 a of the actuator 168 wherein,subsequently, the firing nut 163 may move distally independently of theactuator 168 thereby leaving behind the actuator 168 and the firingmember 165. Stated another way, the distal end 114 of the longitudinalshaft slot 113 may deactivate the firing member 165 wherein, at suchpoint, the position of the firing member 165 may represent thefully-fired or distal-most position of the firing member 165. In such aposition, the clip 140 has been fully advanced into the receivingcavity, or receiver, 122. Furthermore, in such a position, the next clip140 to be advanced into the receiving cavity 122 may be biased againstthe top surface of the firing member 165, further to the above.

Once a clip 140 has been positioned within the receiving cavity 122,further to the above, the clip 140 can be deformed by a crimping drive180, for example. Referring now to FIGS. 277 and 278, the end effector120 of the clip applier 100 can further comprise a first jaw 123 a and asecond jaw 123 b wherein the first jaw 123 a and the second jaw 123 bcan at least partially define the receiving chamber 122. As illustratedin FIGS. 277 and 278, the first jaw 123 a can comprise a first channel124 a and the second jaw 123 b can comprise a second channel 124 b whichcan each be configured to receive and support at least a portion of aclip 140 therein. The first jaw 123 a can be pivotably coupled to aframe 111 of the shaft 110 by a pin 125 a and the second jaw 123 b canbe pivotably coupled to the frame 111 by a pin 125 b. In use, thecrimping drive 180 can be configured to rotate the first jaw 123 atoward the second jaw 123 b and/or rotate the second jaw 123 b towardthe first jaw 123 a in order to compress the clip 140 positionedtherebetween. In at least one such embodiment, the crimping drive 180can comprise a cam actuator 181 which can be configured to engage afirst cam surface 126 a defined on the first jaw 123 a and a second camsurface 126 b on the second jaw 123 b in order to pivot the first jaw123 a and the second jaw 123 b toward one another. The cam actuator 181can comprise a collar which at least partially surrounds the first jaw123 a and the second jaw 123 b. In at least one such embodiment, thecollar can comprise an inner cam surface 182 which can be contoured tocontact the cam surfaces 126 a, 126 b of the jaws 123 a, 123 b and drivethem inwardly toward one another. In various circumstances, the clip 140positioned within the receiving chamber 122 defined in the end effector120 can be positioned relative to tissue before the crimping drive 180is actuated. In some circumstances, the crimping drive 180 can be atleast partially actuated prior to positioning the clip 140 relative tothe tissue in order to at least partially compress the clip 140. Incertain instances, the clip 140 and the receiving chamber 122 can besized and configured such that the clip 140 can be biased or flexedinwardly when the end effector 120 is in its unactuated state, asillustrated in FIG. 277. In various instances, the crimping first jaw123 a and the second jaw 123 b can be actuated to elastically crimpand/or permanently crimp the clip 140 positioned therebetween.

Further to the above, the firing nut 163 can be configured to actuatethe crimping drive 180. More particularly, referring now to FIG. 281,the crimping drive 180 can comprise a crimping actuator 188 operablycoupled with the cam actuator 181 wherein the crimping actuator 188 canbe selectively engaged by the firing nut 163 as the firing nut 163 isadvanced distally as described above. In at least one such embodiment,the firing nut 163 can further comprise a second firing pin, such asfiring pin 184, for example, extending therefrom which can be configuredto engage the crimping actuator 188 as the firing nut 163 is advancingthe firing actuator 168. Referring again to FIG. 281, the crimpingactuator 188 is positioned in an unactuated position and, when thefiring nut 163 is advanced sufficiently to engage a distal arm 190 a ofthe crimping actuator 188, the firing nut 163 can rotate the crimpingactuator 188 upwardly into an actuated position as illustrated in FIG.282. As also illustrated in FIG. 282, the distal arm 190 a and aproximal arm 190 b can each comprise a projection, such as projections191 a and 191 b, respectively, extending therefrom which can bepositioned within a second longitudinal slot defined in shaft 110, suchas slot 115, for example. As the crimping actuator 188 is rotatedupwardly from its unactuated position about a pivot 189, the projections191 a and 191 b can move from the proximal curved end 116 of thelongitudinal slot 115 into a portion of the longitudinal slot 115 whichis substantially linear. Similar to the above, the sidewalls of thelongitudinal slot 115 can be configured to confine the movement of thecrimping actuator 188 along a longitudinal path and can be configured tolimit or prevent the rotation of the crimping actuator 188 once thecrimping actuator 188 has been rotated upwardly into an at leastpartially actuated position, as discussed above. As the reader willunderstand, the firing pin 172 of the firing drive 160 and the firingpin 184 of the crimping drive 180 both extend from the firing nut 163.For the sake of expediency and demonstration, the firing pins 172 and184 are illustrated as extending from the same side of the firing nut163; however, it is envisioned that the firing pin 172 can extend from afirst lateral side of the firing nut 163 while the firing pin 184 canextend from the other lateral side of the firing nut 163. In suchcircumstances, the firing actuator 168 can be positioned alongside thefirst lateral side of the drive screw 161 and the crimping actuator 188can be positioned alongside the opposite lateral side of the drive screw161. Correspondingly, the longitudinal slot 113 can be defined in afirst lateral side of the shaft housing 112 while the longitudinal slot115 can be defined in the opposite lateral side of the shaft housing112.

Further to the above, the cam actuator 181 can be operably coupled withcrimping actuator 188 such that, when the crimping actuator 188 isadvanced distally by the firing nut 163, the cam actuator 181 can beadvanced distally, as illustrated in FIGS. 282 and 284, until the distalprojection 191 a extending from the distal arm 190 a reaches the distalend 117 of the longitudinal slot 115. In such a distal position, the camactuator 181 may be in a fully advanced position and the clip 140positioned within the receiving chamber 122 can be in a fully deformedor crimped configuration. Thereafter, the cam actuator 181 can beretracted and the end effector 120 can be reopened. More particularly,the drive screw 161 can be rotated in an opposite direction in order tomove the firing nut 163 proximally and retract the cam actuator 181wherein, in certain instances, the end effector 120 can further includea biasing member which can be configured to bias the first jaw 123 andthe second jaw 123 b from the closed, or fired, position illustrated inFIG. 278 into the open, or unfired, position illustrated in FIG. 277. Asthe firing nut 163 is retracted from its position illustrated in FIG.284, the firing pin 184 extending from the firing nut 163 can engage theproximal arm 190 b of the crimping actuator 188 and move the crimpingactuator 188, and the cam actuator 181 extending therefrom, proximallyas illustrated in FIG. 286. Similar to the above, the proximalprojection 191 b extending from the proximal arm 190 b of the crimpingactuator 188 can be configured to contact the sidewall of the curvedproximal end 116 wherein the sidewall can guide the crimping actuator188 downwardly and rotate the crimping actuator 188 about the pivot 189.At such point, the firing pin 184 may no longer be engaged with thecrimping actuator 188, the cam actuator 181 may be fully retracted, andthe firing nut 163 may continue to be retracted proximally relative tothe crimping actuator 188.

Further to the above, referring now to FIG. 285, the firing nut 163 canbe configured to re-engage the firing actuator 168 as the firing nut 163is being retracted proximally. As discussed above, the firing actuator168 is rotated downwardly when the firing actuator 168 reaches thedistal end 114 of the longitudinal slot 113 and, as a result, the firingactuator 168 may still be in its downwardly rotated position when thefiring nut 163 is retracted proximally to re-engage the firing actuator168. As illustrated in FIG. 285, the firing pin 172 extending from thefiring nut 163 can engage the proximal arm 170 b of the firing actuator168 and, as the firing nut 163 is further retracted, the firing nut 163can rotate the firing actuator 168 upwardly such that the projections171 a and 171 b extending from the arms 170 a and 170 b, respectively,can re-enter the longitudinal portion of the longitudinal slot 113.Thereafter, the firing nut 163 and can be retracted until the firingactuator 168 and the firing member 165 extending therefrom have beenreturned to their starting, or unfired, positions illustrated in FIG.279. In such circumstances, the firing member 165 can be withdrawn fromthe clip cartridge 130 as the firing member 165 is retracted proximallyby the firing nut 163 such that a new clip 140 can be biased into thefiring chamber of the clip cartridge 130 by the biasing member 136. Oncethe firing member 165 and the firing actuator 168 have been retracted totheir starting positions and the next clip 140 has been positionedwithin the firing chamber, the firing drive 160 can be actuated onceagain in order to move the firing nut 163 and the firing member 165distally to advance the next clip 140 into the end effector 120.Likewise, the firing nut 163 can re-actuate the crimping drive 180 asthe firing nut 163 is moved distally once again in order to deform thenext clip 140. Thereafter, the firing nut 163 can retracted in order tore-set the crimping drive 180 and the firing drive 160 once again. Thisprocess can be repeated until a sufficient number of clips 140 have beenapplied to the targeted tissue and/or until the clips 140 containedwithin the clip cartridge 130 have been depleted. In the event thatadditional clips 140 are needed, the expended clip cartridge 130 can beremoved from the shaft 110 and a replacement clip cartridge 130containing additional clips 140 can be inserted into the shaft 110. Insome circumstances, an at least partially depleted clip cartridge 130can be replaced with an identical, or at least nearly identical,replacement clip cartridge 130 while, in other circumstances, the clipcartridge 130 can be replaced with a clip cartridge having more than orless than five clips 140 contained therein and/or a clip cartridgehaving clips other than clips 140 contained therein, for example.

Referring again to FIGS. 280-283, the firing nut 163 of the illustratedembodiment can be configured to become disengaged from the firingactuator 168 at the same time that the firing nut 163 becomes engagedwith the crimping actuator 188. Stated another way, the firing drive 160can be deactivated at the same time that the crimping drive 180 isactivated. In various circumstances, such timing can be achieved whenthe distal end 114 of the longitudinal slot 113 is aligned, or at leastsubstantially aligned, with the proximal end 116 of the secondlongitudinal slot 115, for example. In the illustrated embodiment and/orany other suitable embodiment, a lag can exist between the deactivationof the firing drive 160 and the activation of the crimping drive 180.Such a lag between the end of the firing stroke of the firing member 165and the beginning of the firing stroke of the cam actuator 181 can becreated, in some circumstances, to assure that the clip 140 has beenpositioned in its fully-seated position within the receiving chamber 122before the clip 140 is deformed by the cam actuator 181. In variouscircumstances, such a lag can be created when the distal end 114 of thelongitudinal slot 113 is positioned proximally with respect to theproximal end 116 of the second longitudinal slot 115, for example. Inthe illustrated embodiment and/or any other suitable embodiment, thedeactivation of the firing drive 160 may occur after the activation ofthe crimping drive 180. Such an overlap between the end of the firingstroke of the firing member 165 and the beginning of the firing strokeof the cam actuator 181 can be created, in some circumstances, to applyat least some inward pressure on the clip 140 as it is moved into itsfully-seated position within the receiving chamber 122 so as to reduceor eliminate relative movement between the clip 140 and the sidewalls ofthe receiving chamber 122, for example. In various circumstances, suchan overlap can be created when the distal end 114 of the longitudinalslot 113 is positioned distally with respect to the proximal end 116 ofthe second longitudinal slot 115, for example.

In the illustrated embodiment of FIG. 275 and/or any other suitableembodiment, turning now to FIG. 291, a clip cartridge, such as clipcartridge 230, for example, can comprise a pusher plate 248 positionedintermediate the biasing member 136 and the top-most clip 140 stackedwithin the clip cartridge 230. The pusher plate 248 can be rigid, or atleast substantially rigid, and can comprise a first bearing surfaceagainst which the biasing member 136 can apply a biasing force. Thepusher plate 248 can also comprise a second bearing surface which cantransmit the biasing force to the top surface 145 of the top-most clip140. The pusher plate 248 can be comprised of a sheet of stainless steelmaterial, for example, although the pusher plate 248 can comprise anysuitable shape and can be comprised of any suitable material. In certaininstances, the pusher plate 248 may not be attached to the biasingmember 136 while, in other instances, the pusher plate 248 can beaffixed to the biasing member 136 such that the pusher plate 248 doesnot become dislodged from the cartridge housing 132. In variouscircumstances, the pusher plate 248 can be sized and configured suchthat it cannot pass through the proximal opening 133 and/or the distalopening 137 defined in the cartridge housing 132.

In the illustrated embodiment of FIG. 275 and/or any other suitableembodiment, turning now to FIGS. 292 and 293, a clip cartridge, such asclip cartridge 330, for example, can comprise a lockout member which canbe positioned within the firing chamber 149 of the clip cartridge 330after all of the clips 140 contained within the clip cartridge 330 havebeen ejected from the cartridge 330. The lockout member can comprise alockout plate 348 which can be positioned intermediate the biasingmember 136 and the top surface 145 of the top-most clip 140 containedwithin the clip cartridge 330. In use, further to the above, the clips140 can be sequentially positioned in the firing chamber 149 of the clipcartridge 130 and then advanced distally out of the clip housing 132wherein, after the last clip 140 has been advanced out of the cliphousing 132 and the firing member 165 has been withdrawn from the clipcartridge 130, the biasing member 136 can bias the lockout plate 348against the shelves 135. In such a position, the lockout plate 348 canbe aligned with the proximal opening 133 and the distal opening 137 suchthat the firing member 165 cannot enter, or at least substantiallyenter, the clip cartridge 130. In such circumstances, the lockout plate348 can block the firing member 165 from entering into and passingthrough the housing 132 and, as a result, prevent the inadvertent firingof the clip applier 100 after the clip cartridge 130 has run out ofclips. In the event that the operator of the clip applier 100 were toactuate the firing drive 160 and attempt to advance the firing member165 into the spent clip cartridge 130, the firing member 165 wouldcontact and abut the lockout plate 348 wherein, in such circumstances, acompressive load can be created within the firing member 165. The clipapplier 100 can further include a clutch which can be configured to slipand operably disconnect the motor from the drive screw 161 when thecompressive load created within the firing member 165 exceeds a certainor predetermined amount. In addition to or in lieu of a clutch, themotor and/or motor controller of the clip applier 100 which operates thefiring drive 160, for example, can comprise a load sensor configured todetect the load generated within the firing member 165 and, when theload created within the firing member 165 exceeds a certain orpredetermined amount, the voltage and/or current supplied to the motorcan be switched off and/or reduced. In any event, the lockout plate 348can be sized and configured such that the lockout plate 348 cannot bedislodged through the distal opening 137 and/or the proximal opening 133when the firing member 165 contacts the lockout plate 348. In order touse the clip applier 100 once again, the operator of the clip applier100 can remove the spent cartridge 330 from the shaft 110 and insert anew clip cartridge 330, for example, into the shaft 110. At such point,a clip 140 may be positioned within the firing chamber 149 of the newclip cartridge 330 and the firing member 165 can be advanced distallyinto the new clip cartridge 330 to deploy the clip 140 as describedabove.

In the illustrated embodiment of FIG. 275 and/or any other suitableembodiment, referring now to FIGS. 294 and 295, a clip cartridge, suchas clip cartridge 430, for example, can comprise guides which can beconfigured to limit or confine the movement of a lockout member withinthe clip cartridge 430. Similar to the above, the lockout member cancomprise a lockout plate 448, for example, which can be positionedintermediate the biasing member 136 and the top surface 145 of thetop-most clip 140 contained within the housing 432 of the clip cartridge430. In use, similar to the above, the lockout plate 448 can beprogressively pushed downwardly into the firing chamber 149 as the clips140 are sequentially ejected from the clip cartridge 430. The lockoutplate 448 can be sized and configured such that it is closely receivedwithin the cartridge housing 432 and such that relative lateral movementbetween the lockout plate 448 and the housing 432 can be limited inorder to reduce, or prevent, the possibility of the lockout plate 448becoming misaligned within the clip cartridge 430. In the event that thelockout plate 448 were to become misaligned within the clip cartridge430, the lockout plate 448 may bind within the housing 432 and preventthe biasing member 136 from applying an appropriate biasing force to thestack of clips 140, for example. As illustrated in FIGS. 294 and 295,the lockout plate 438 can further comprise guide members 447 extendingtherefrom which can be received within guide slots 446 defined in thecartridge housing 432. The guide members 447 and the guide slots 446 canbe sized and configured such that the guide members 447 are closelyreceived within the guide slots 446 and such that relative lateralmovement between the lockout plate 438 and the cartridge housing 432 canbe limited. Each of the guide slots 446 can be defined by opposingsidewalls 445 which can define a distance therebetween which is equal toor slightly larger than the width of the guide member 447 positionedtherein such that the guide member 447 can slide between the opposingsidewalls 445 between the top 443 and the bottom 444 of the guide slot446. Thus, while the guide members 447 and the guide slots 446 can beconfigured to limit lateral movement therebetween, as outlined above,the guide members 447 and the guide slots 446 can be configured topermit relative movement between the lockout plate 438 and the cartridgehousing 432 along a predetermined path parallel to or collinear with thesupply axis 138, for example. When the lockout plate 438 is pushed intothe firing chamber 149 by the biasing member 136, the lockout plate 438can inhibit the advancement of the firing member 165 and the operationof the clip applier 100, as outlined above, until the spent clipcartridge 430 is replaced with another suitable clip cartridge.

In the illustrated embodiment of FIG. 275 and/or any other suitableembodiment, as discussed above, the drive screw 161 can be rotated in afirst direction to advance the firing nut 163 distally and rotated in asecond, or reverse, direction to retract the firing nut 163 proximally.In order to rotate the drive screw 161 in the first and seconddirections, the electric motor operably coupled with the drive screw 161can be operated in corresponding first and second directions. In theillustrated embodiment of FIG. 275 and/or any other suitable embodiment,a clip applier can utilize a motor which is operated in only a firstdirection wherein the rotation of the motor in such a single directioncan be utilized to advance a firing nut distally and retract the firingnut proximally. Turning now to FIGS. 296-300, the output of an electricmotor can be transmitted to a drive system 560 via a transmission system550. The transmission system 550 can comprise an input shaft 552 whichis operated in a single direction wherein the transmission system 550can be switchable or shiftable between a first state, or configuration,in which the transmission system 550 rotates a drive screw 561 of thedrive system 560 in a first direction and a second state, ofconfiguration, in which the transmission system 550 rotates the drivescrew 561 in a second, or opposite, direction. The first state of thetransmission system 550 is depicted in FIGS. 296-298 and the secondstate of the transmission system 550 is depicted in FIGS. 299 and 300.

Referring again to FIGS. 296-298, the input shaft 552 can comprise aninput gear 551 mounted thereto which is operably coupled, or meshinglyengaged, with a shifter gear 553 such that the rotation of the inputshaft 552 is transmitted to the shifter gear 553. With regard to all ofthe gears discussed herein, gears which are operably coupled ormeshingly engaged with one another can comprise any suitable arrangementof teeth, for example, which can transmit the rotation of one gear tothe other. When the input shaft 552 is rotated in the first direction,the shifter gear 553 is rotated in the second, or opposite, direction.In the first state of the transmission system, the shifter gear 553 isin a first position in which the shifter gear 553 is operably coupledwith an intermediate gear 554 wherein, when the shifter gear 553 isrotated in the second direction by the input gear 551, as discussedabove, the intermediate gear 554 is rotated in the first direction.Although not illustrated, the intermediate gear 554 can be rotatablysupported within the shaft 110 of the clip applier 100, for example. Theintermediate gear 554 can also be operably coupled with an output gear555 mounted to the drive screw 561 such that the rotation of theintermediate gear 554 can be transmitted to the output gear 555. Whenthe intermediate gear 554 is driven in the first direction by theshifter gear 553, as described above, the intermediate gear 554 candrive the output gear 555 and the drive screw 561 in the seconddirection. Similar to the above, the firing nut 563 can be operablycoupled with the drive screw 561 and suitably constrained within theshaft 110 such that, when the drive screw 561 is rotated in the seconddirection, the firing nut 563 is advanced distally as indicated by thearrow D.

Similar to the above, the firing nut 563 can be advanced to itsdistal-most position, illustrated in FIG. 298, in order to advance aclip 140 from the clip cartridge 130 into the end effector 120 and crimpthe clip 140 as described above. As illustrated in FIGS. 297 and 298,the firing nut 563 can further comprise a cam bar 569 extendingtherefrom which can be configured to shift the transmission system 550from its first state to its second state. Upon comparing FIG. 298 andFIG. 299, the reader will note that the shifter gear 553 is movablebetween a first position in which the transmission system 550 is in itsfirst state and a second position in which the transmission system 550is in its second state. More particularly, the shifter gear 553 ismounted to a shifter 556 which is rotatable about the input shaft 552such that the shifter gear 553 can be rotated from its first position inwhich the shifter gear 553 is operably engaged with the input gear 551and the intermediate gear 554 and its second position in which theshifter gear 553 is operably disengaged from the intermediate gear 554.Although the shifter gear 553 is operably disengaged from theintermediate gear 554 when the shifter gear 553 is in its secondposition, the shifter gear 553 can be operably coupled with the inputgear 551 and the output gear 555 in order to transmit rotary motion fromthe input shaft 552 to the drive screw 561. As illustrated in FIGS. 298and 299, the shifter 556 can comprise a central aperture through whichthe input shaft 552 can extend; however, the shifter 556 may not beoperably engaged with the input shaft 552 and, as a result, the rotationof the input shaft 552 may not rotate the shifter 556 and, likewise, therotation of the shifter 556 may not rotate the input shaft 552. In anyevent, the shifter 556 can further comprise a cam follower 558 extendingtherefrom which can be engaged by a cam 568 defined on the cam bar 569as the firing nut 563 is advanced distally. When the cam 568 engages thecam follower 558, the cam 568 can rotate the shifter 556 and the shiftergear 553 between its first position and its second position as describedabove.

When the shifter gear 553 is in its second position and the transmissionsystem 550 is in its second state, as described above, the input shaft552 and the drive screw 561 can both be rotated in the first direction.More particularly, the input shaft 552, when rotated in the firstdirection, can rotate the input gear 551 in the first direction and, asthe shifter gear 553 is directly engaged with the input gear 551, theshifter gear 553 will be rotated in the second direction. The readerwill note that the shifter gear 553 rotates in the second direction whenthe transmission system 550 is in its second state as compared to thefirst, or opposite, direction when the transmission system 550 is in itsfirst state. Upon comparing FIGS. 298 and 299, further to the above, thereader will appreciate that the intermediate gear 554 is no longeroperably positioned intermediate the input gear 551 and the shifter gear553 when the transmission system 550 is in its second state therebyaccounting for the different directions of rotation. As the shifter gear553 is operably engaged with the input gear 551 and the output gear 555when the shifter gear 553 is in its second position, the shifter gear553 can rotate the output gear 555, and the drive screw 561 coupled tothe output gear 555, in the first direction. When the drive screw 561 isrotated in the first direction, as illustrated in FIGS. 299 and 300, thefiring nut 563 can be retracted proximally to permit the end effector120 to be reopened and to retract the firing member 165. Referringprimarily to FIG. 300, the firing nut 563 can further comprise a secondcam bar 567 extending therefrom comprising a cam 566 which can beconfigured to contact the cam follower 558 of the shifter 556 as thefiring nut 563 is retracted proximally into its fully-retractedposition. In such circumstances, the cam 566 can push the shifter 556back into its first position and into operative engagement with theintermediate gear 554 such that the transmission system 550 can be resetinto its first state and the clip applier 100 can be actuated onceagain.

As discussed above, the firing drive of the clip applier 100 can beoperated by a surgical instrument system comprising an electric motor. Arobotic surgical instrument system 20 is illustrated in FIG. 301 and cancomprise a plurality of movable arms 30. Each arm 30 can comprise anactuator module 32 comprising an electric motor configured to supply therotary motion to the shaft 110 of a clip applier 100, and/or any othersuitable surgical instrument. Referring now to FIG. 302, an end effector620 may be selectively engageable with and disengageable from anactuator shaft 610 of a clip applier wherein the end effector 620 cancomprise a proximal end 621 which can be coupled to a distal end 611 ofthe shaft 610. The proximal end 621 of the end effector 620 can comprisean outer housing 629, a frame extending through the outer housing 629,an outer drive shaft extending through the frame, and an inner driveshaft extending through the outer drive shaft. Similarly, the distal end611 of the shaft 610 can comprise an outer housing 619, a frame 663extending through the outer housing 619, an outer drive shaft 662extending through the frame 663, and an inner drive shaft 661 extendingthrough the outer drive shaft 662. With regard to the distal end 611 ofthe shaft 610, the frame 663, the outer drive shaft 662, and the innerdrive shaft 661 can each comprise a portion of a tongue connector 613extending therefrom and a portion of a connector groove 612 definedtherein, wherein the tongue connector 613 can be configured to bereceived within a tongue groove 623 defined in the proximal end 621 ofthe end effector 620, and wherein the tongue groove 612 can beconfigured to receive a tongue connector 622 extending from the proximalend 621 of the end effector 620. Similar to the tongue connector 613which extends across the frame 663, the outer drive shaft 662, and theinner drive shaft 661 of the distal shaft end 611, the tongue connector622 can extend across the frame, the outer drive shaft, and the innerdrive shaft of the proximal end 621 of the end effector 620. Also,similar to the tongue groove 612 which extends across the frame 663, theouter drive shaft 662, and the inner drive shaft 661 of the distal shaftend 611, the tongue groove 623 can extend across the frame, the outerdrive shaft, and the inner drive shaft of the proximal end 621 of theend effector 620. In the configuration depicted in FIG. 302, the tongueconnector 622 of the end effector 620 can be slid laterally into thetongue groove 612 of the shaft 610 at the same time that the tongueconnector 613 of the shaft 610 is slid laterally into the tongue groove623 of the end effector 620. Owing to such assembly, the frame of theend effector 620 can be securely coupled to the frame 663 of the shaft610, the outer drive shaft of the end effector 620 can be operablycoupled to the outer drive shaft 662 of the shaft 110, and the innerdrive shaft of the end effector 620 can be operable coupled to the innerdrive shaft 661 of the shaft 110. The reader will note that the portionsof the tongue connector 612 are aligned with one another, the portionsof the tongue groove 613 are aligned with one another, the portions ofthe tongue groove 622 are aligned with one another, and the portions ofthe tongue connector 623 are aligned with one another when the endeffector 620 is assembled to the shaft 610. Once assembled, the outerdrive shaft 662 of the shaft 110 can rotate the outer drive shaft of theend effector 620, and the inner drive shaft 661 of the shaft 610 canrotate the inner drive shaft of the end effector 620. When the outerdrive shaft 662 and/or the inner drive shaft 661 are rotated, theportions of the tongue connector 612, the portions of the tongue groove613, the portions of the tongue groove 622, and the portions of thetongue connector 623 may no longer be aligned. In order to remove theend effector 620 from the shaft 610, the inner drive shaft 661 and/orthe outer drive shaft 662 can be rotated into one or more positions inwhich the tongue connectors 612 and 623 and the tongue grooves 613 and622 are sufficiently aligned.

Referring again to FIG. 302, the outer housing 619 of the shaft 610 canfurther comprise a stop 614 which can be configured to limit the lateralmovement of the end effector 620 as the end effector 620 is being slidtransversely onto the distal end 611 of the shaft 610. The stop 614 canprovide a datum from which the inner drive shaft of the end effector 620and the inner drive shaft 661 of the shaft 610 are aligned alonglongitudinal axis 615, the outer drive shaft of the end effector 620 andthe other drive shaft 662 of the shaft 610 are aligned alonglongitudinal axis 615, and/or the frame of the end effector 620 and theframe 663 of the shaft 610 are aligned along the longitudinal axis 615.Further to the above, the inner drive shaft 661 can extend into anactuator module 632 which can comprise an electric motor and/or geartrain 664 operably coupled with the inner drive shaft 661 configured torotate the inner drive shaft 661. Furthermore, the actuator module 632can comprise a second electric motor and gear train operably engagedwith the second drive shaft 662 configured to drive the second driveshaft 662. As described in greater detail below, a second electric motorcan be utilized to articulate the end effector 620. Also, further to theabove, the outer housing 619 and/or the frame 663 of the shaft 610 canfurther comprise a gear 617 mounted thereto which is operably engagedwith an electric motor and gear train 618 which can be configured torotate the shaft 610 and the end effector 620 about the longitudinalaxis 615. For instance, if the electric motor and gear train 618 areoperated in a first direction, the shaft 610 and the end effector 620can be rotated about the axis 615 in a clockwise direction while, if theelectric motor and gear train 618 are operated in a second direction,the shaft 610 and the end effector 620 can be rotated about the axis 615in a counter-clockwise direction in order to position and orient the endeffector 620.

As discussed above, the end effector 620 can be selectively attached toand detached from the shaft 610. The reader will note that theprinciples discussed in connection with the end effector 620 and shaft610 can be equally applied to the end effector 120 and the shaft 110 ofthe embodiment disclosed in FIG. 275, among others.

That said, referring again to FIG. 301, one of the robotic arms 30 canbe selectively engaged with an end effector 120 of a clip applier or,alternatively, any other suitable end effector, such as the end effectorof a surgical stapler, for example. In such circumstances, an endeffector 120 can be selectively interchanged with another end effectorand, as a result, a single robotic arm 30 can be utilized to performmore than one function. Stated another way, the clip applier 100 cancomprise a replaceable loading unit which can be replaced by, orinterchanged with, another clip applier loading unit and/or any othersuitable replaceable loading unit. Turning now to FIG. 303, the endeffector 120 and the shaft 110 of the clip applier 100 can be utilizedwith a surgical instrument system comprising a handle 700. The handle700 can comprise an actuator 701 which can be operated, or squeezedtoward grip 702, in order to apply a rotary motion to the drive screw161 as described above. In some cases, the rotation of the actuator 701can be mechanically transmitted to the drive screw 161 while, in othercases, the actuator 701 can operate a motor operably coupled to thedrive screw 161.

Further to the above, the end effector 120 and the shaft 110 of the clipapplier 100 can be aligned along a longitudinal axis of the clip applier100. Turning now to FIG. 304, the end effector 120 and/or the shaft 110can further comprise an articulation joint 101 which can be configuredto permit the end effector 120 to be articulated relative to thelongitudinal axis of the clip applier 100. The shaft 110 can comprise anouter housing, or frame portion, 119 which can comprise a proximal end102 and can comprise a distal portion of the articulation joint 101. Theproximal end 102 can comprise a spherical, or an at least substantiallyspherical, end 102, for example, which can be received within aspherical, or an at least substantially spherical, cavity 104 defined inan articulation joint member 103. The articulation joint member 103 canalso comprise a spherical, or at least substantially spherical, end 105,for example, which can be received within a spherical, or an at leastsubstantially spherical, cavity 107 defined in a shaft frame portion106. The proximal end 102 of the shaft 110 can be at least partiallycaptured within the cavity 104 such that the proximal end 102 cannot bereadily removed from the cavity 104. That said, the proximal end 102 andthe cavity 104 can be sized and configured to permit the proximal end102 to be rotated in any suitable direction within the cavity 104. Asalso illustrated in FIG. 304, the clip applier 100 can further comprisearticulation controls 108 a and 108 b, for example, which can extendthrough the articulation joint 101 and can comprise distal ends mountedwithin mounting apertures 109 a and 109 b, respectively, defined withinthe proximal end 102 of the shaft housing 119. In use, the articulationcontrols 108 a and 108 b can be pushed and/or pulled in order to movethe proximal end 102 within the cavity 104. Further to the above, theend 105 of the articulation joint member 103 can be at least partiallycaptured within the cavity 107 defined in the shaft frame portion 106such that the end 105 cannot be readily removed from the cavity 107.That said, the end 105 and the cavity 107 can be sized and configured topermit the end 105 to be rotated in any suitable direction within thecavity 107 when the shaft end 102 is pushed and/or pulled by theactuators 108 a and 108 b as described above.

Further to the above, referring again to FIG. 304, the drive screw 161can be rotated by an input shaft, such as input shaft 152, for example.The input shaft 152 can extend through an aperture 156 defined withinthe shaft frame portion 106, the articulation joint member 103, and theproximal end 102 of the shaft housing 119. The input shaft 152 cancomprise an input gear 151 mounted to the distal end thereof which canbe operably coupled with an output gear 155 mounted to the proximal endof the drive screw 161. In use, the input shaft 152 can be rotated bythe electric motor, described above, wherein the input shaft 152 canrotate the drive screw 161. As outlined above, the articulation joint101 can be configured to permit the end effector 120 and at least aportion of the shaft 110 to be articulated relative to a longitudinalaxis defined by the clip applier 100. In order to accommodate suchmovement, at least the portion of the input shaft 152 extending throughthe articulation joint 101 can be sufficiently flexible.

Turning now to FIGS. 305-308, the articulation actuators 108 a and 108 bcan be operated by an actuator module such as module 832, for example.Referring primarily to FIG. 305, the actuator module 832 can comprise arotatable articulation driver 833 which can be configured to push andpull the articulation actuators 108 a and 108 b. The articulation driver833 can comprise a cylindrical, or an at least substantiallycylindrical, collar 835 including an aperture 837 which can beconfigured to receive at least a portion of the shaft frame 106 thereinin order to rotatably support the collar 835. The articulation driver833 can further comprise an input gear portion 834 which can be operablycoupled with an electric motor and gear train 831 of the module 832wherein, when the electric motor and gear train 831 are actuated, thearticulation driver 833 can be rotated about the shaft frame 106.Referring primarily to FIGS. 306 and 308, the articulation driver 833can further comprise two cam slots defined in the sidewall of the collaraperture 837, although the reader will note that only one cam slot 835 ais illustrated in the provided views. The cam slot 835 a is configuredto receive a cam follower 838 a extending from the articulation driver108 a wherein the cam follower 838 a is configured to slide within thecam slot 835 a. When the articulation driver 833 is rotated, the helicalcontour of the cam slot 835 a, for example, can be configured to pushthe cam follower 838 a distally or pull the cam follower 838 aproximally, depending on the direction in which the articulation driver833 is rotated. As a result of the proximal or distal movement of thecam follower 838 a, the cam actuator 108 a can be moved proximally ordistally, respectively. While not illustrated, the articulation driver108 b can comprise a cam follower, similar to the cam follower 838 a,which can be configured to slide within the other cam slot discussedabove. The other cam slot can be configured such that, when thearticulation actuator 108 a is driven distally by the articulationdriver 833 when the articulation driver 833 is rotated in a firstdirection, the articulation actuator 108 b can be pulled proximally.Similarly, the other cam slot can be configured such that, when thearticulation actuator 108 a is pulled proximally by the articulationdriver 833 when the articulation driver 833 is rotated in a seconddirection, the articulation actuator 108 b can be driven distally.Referring primarily to FIG. 306, the shaft frame portion 106 cancomprise clearance slots 839 defined therein through which the camfollowers can extend. Although the above features have been discussed inconnection with an actuator module 832, such features could be used inconnection with the other actuator modules disclosed herein.

FIGS. 309, 310, and 311 depict a clip applier 70100 in accordance withat least one embodiment. The clip applier 70100 is similar to the clipapplier 100 in many respects, most of which will not be repeated hereinfor the sake of brevity. Similar to the clip applier 100, the clipapplier 70100 comprises an end effector 70120, a shaft, a clipcartridge, and a firing member 70165. The clip cartridge comprises aplurality of clips 70140 removably stored therein. The end effector70120 comprise a first jaw 70123 a and a second jaw 70123 b wherein thefirst jaw 70123 a and the second jaw 70123 b at least partially define areceiving chamber 70122. Further, the first jaw 70123 a and the secondjaw 70123 b are pivotally coupled to the shaft by a pin 70125 such thatthe first jaw 70123 a and the second jaw 70123 b are movable relative toeach other between an open position (FIG. 310) and a closed position(FIG. 309). The first jaw 70123 a and the second jaw 70123 b are movablebetween the open position and the closed position by a crimping drive70180 (see FIGS. 312-314). Other embodiments are envisioned where thefirst jaw 70123 a and the second jaw 70123 b are pivotally coupled tothe shaft utilizing at least one pin similar to the first jaw 125 a andsecond jaw 125 b depicted in FIG. 275. The first jaw 70123 a and thesecond jaw 70123 b include pre-form features, such as protrusions 70126a and 70126 b which are discussed in further detail below.

In use, the firing member 70165 advances a clip 70140 from the clipcartridge onto the protrusions 70126 a and 70126 b as depicted in FIG.309. In this position, the clip 70140 is in a pre-formed configuration.The width of the clip 70140 in the pre-formed configuration can be0.080″ preferably. When the first jaw 70123 a and the second jaw 70123 bare moved from the closed position to the open position, the protrusions70126 a and 70126 b expand the clip 70140 to an expanded configurationas depicted in FIG. 310. The width of the clip 70140 in the expandedconfiguration can be 0.210″ preferably. During the transition of theclip 70140 from the pre-formed configuration to the expandedconfiguration, the firing member 70165 supports the backside of the clip70140. More specifically, the firing member 70165 includes angledsurfaces 70165 a and 70165 b which provide support for the backside ofthe clip 70140 as the clip 70140 expands. Further, as the clip 70140 isexpanded, the firing member 70165 can be advanced to allow the angledsurfaces 70165 a and 70165 b to continue to maintain contact against thebackside of the clip 70140 as the clip 70140 expands. Once in theexpanded configuration, the clip 70140 is advanced into the receivingchamber 70122 by the firing member 70165. The protrusions 70126 a and70126 b include angled portions which allow the clip 70140 to slide overthe protrusions 70126 a and 70126 b when the clip 70140 is advanced bythe firing member 70165. After the clip 70140 has been advanced into thereceiving chamber 70122, the firing member 70165 is retracted, and thecrimping drive 70180 is actuated to transition the first jaw 70123 a andthe second jaw 70123 b to the closed position depicted in FIG. 309 tocrimp the clip 70140 positioned in the receiving chamber 70122. Afterthe clip 70140 is crimped, another clip 70140 can be advanced onto theprotrusions 70126 a and 70126 b by the firing member 70165. When thefirst jaw 70123 a and the second jaw 70123 b are moved from the closedposition to the open position by the crimping drive 70180, the clip70140 that has been crimped in the receiving chamber 70122 will bereleased from the receiving chamber 70122 and the clip 70140 that wasadvanced onto the protrusions 70126 a and 70126 b will be expanded intoto the expanded configuration by the protrusions 70126 a and 70126 b ofthe first and second jaws 70123 a and 70123 b. Interaction between thecrimping drive 70180 and the first and second jaws 70123 a and 70123 bis discussed in further detail below.

FIGS. 312-314 depict the clip applier 70100 as described above. Inaddition, FIGS. 312-314 further depict the interaction between thecrimping drive 70180 and the first and second jaws 70123 a and 70123 b.The crimping drive 70180 comprises a first crimping drive pin 70180 aand a second crimping drive pin 70180 b protruding therefrom. The firstjaw 70123 a comprises a first jaw cam 70124 a extending therefrom andthe second jaw 70123 b comprises a second jaw cam 70124 b extendingtherefrom. In use, the crimping drive 70180 is movable between a fullyretracted position (FIG. 314), a home position (FIG. 313), and afully-fired position (FIG. 312). The fully-fired position can preferablybe 0.300″ distal to the home position. The fully retracted position canpreferably be 0.050″ proximal to the home position. Other embodimentsare envisioned with different distances between the home position, thefully retracted position, and the fully-fired position. The crimpingdrive 70180 cammingly engages outer surfaces of the first jaw 70123 aand the second jaw 70123 b to transition the first jaw 70123 a and thesecond jaw 70123 b to a closed position when the crimping drive 70180 ismoved into the fully-fired position (FIG. 312)—similar to theinteraction between the crimping drive 180 and the first and second jaws123 a and 123 b described above. In the home position (FIG. 313), thefirst and second crimping drive pins 70180 a and 70180 b engage thefirst jaw cam 70124 a and the second jaw cam 70124 b, respectively, suchthat the first jaw 70123 a and the second jaw 70123 b are moved towardthe open position to release a crimped clip 70140 from the first andsecond jaws 70123 a and 70123 b. When the crimping drive 70180 is in thehome position, another clip 70140 can be advanced onto the protrusions70126 a and 70126 b as discussed above. Further, as the crimping drive70180 is moved from the home position (FIG. 313) to the fully retractedposition (FIG. 314) the first crimping drive pin 70180 a and the secondcrimping drive pin 70180 b transition the first jaw 70123 a and thesecond jaw 70123 b towards the open position, and thus, the clip 70140positioned around the protrusions 70126 a and 70126 b is expanded intothe expanded configuration, as discussed above. Alternative embodimentsare envisioned in which a crimped clip 70140 is released from the firstand second jaws 70123 a and 70123 b and, at the same time, another clip70140 positioned on the protrusions 70126 a and 70126 b is leastpartially expanded when the crimping drive is moved from the closedposition to the home position.

FIGS. 315 and 316 depict a clip applier 70150 in accordance with atleast one embodiment. The clip applier 70150 comprises a frame 70155, afiring member 70160, a first jaw 70170 a, and a second jaw 70170 b. Thefirst jaw 70170 a and the second jaw 70170 b are pivotally coupled tothe frame 70155 such that the first jaw 70170 a and the second jaw 70170b are movable relative to each other. The clip applier 70150 isconfigured to receive various types of clip cartridges, such as clipcartridge 70130 depicted in FIG. 315, for example. The clip cartridge70130 comprises a cartridge body 70132 including a first cartridge jaw70132 a and a second cartridge jaw 70132 b that oppose each other. Whenthe clip cartridge 70130 is attached to the frame 70155 of the clipapplier 70150, the first cartridge jaw 70132 a biases the first jaw70170 a towards the second jaw 70170 b, and the second cartridge jaw70132 b biases the second jaw 70170 b towards the first jaw 70170 a.Thus, when the clip cartridge 70130 is attached to the clip applier70150, the first and second jaws 70170 a and 70170 b are approximated toform a receiving chamber 70175. The clip cartridge 70130 furthercomprises a plurality of clips 70136 removably stored in a clip housing70134. The clip cartridge 70130 further includes biasing members, suchas springs 70138 for example, configured to bias the clips 70136 out ofthe clip housing 70134 into the receiving chamber 70175. Once in thereceiving chamber 70175, a clip 70136 can be advanced by the firingmember 70160 into a crimping chamber in the distal end of the first andsecond jaws 70170 a and 70170 b. A clip 70136 positioned in the crimpingchamber can then be crimped when the first jaw 70170 a and the secondjaw 70170 b are moved towards each other.

FIG. 316 depicts a different clip cartridge 70130′ positioned in theclip applier 70150. The clip cartridge 70130′ is similar to clipcartridge 70130 discussed above, except for the differences discussedbelow. The clip cartridge 70130′ is configured to store clips 70136′which are smaller than clips 70136. Other embodiments are envisionedwhere the clip cartridge 70130′ is configured to store clips that arelarger than clips 70136. In any event, clip cartridge 70136′ comprises,one, a clip housing 70134′ which stores the clips 70136′ and, two,biasing members, such as springs 70138′ for example, which bias thestored clips 70136′ into a receiving chamber 70175′. Further, the clipcartridge 70130′ comprises a cartridge body 70132′, a first cartridgejaw 70132 a′, and a second cartridge jaw 70132 b′ opposing the firstcartridge jaw 70132 a′. The first cartridge jaw 70132 a′ and the secondcartridge jaw 70132 b′ extend further inward toward each other ascompared to the first cartridge jaw 70132 a and the second cartridge jaw70132 b of the clip cartridge 70130. Stated another way, the gap betweenthe first cartridge jaw 70132 a′ and the second cartridge jaw 70132 b′is smaller than the gap between the first cartridge jaw 70132 a and thesecond cartridge jaw 70132 b. When the clip cartridge 70130′ is attachedto the clip applier 70150, the receiving chamber 70175′ defined betweenthe first jaw 70170 a and the second jaw 70170 b will be smaller thanthe receiving chamber 70175. By changing the distance between the firstcartridge jaw and the second cartridge jaw of the clip cartridges 70130and 70130′, various sizes of receiving chambers can be created. The clipcartridges 70130 and 70130′ can therefore be modified to approximate thefirst jaw 70170 a and the second jaw 70170 b of the clip applier 70150to receive any suitable clip size.

FIG. 317 depicts a clip applier 70200 in accordance with at least oneembodiment. The clip applier comprises a shaft 70210 extending from ahousing, an end effector 70220 extending from the shaft 70210, a feedermember 70230 configured to move through the clip applier 70200 inresponse to rotary motions generated in the housing, and a clip magazine70240. The end effector comprises a pair of jaws 70225 configured tomove relative to each other between open and closed positions. The clipmagazine 70240 is not removable from the clip applier 70200; however,other embodiments are envisioned where the clip magazine 70240 isremovable and/or replaceable. The clip magazine 70240 comprises a firstlayer 70246 of clips 70244 and a second layer 70248 of clips 70244stored within the clip magazine 70240. The first layer 70246 of clips70244 are in a feeding position from which they can be ejected from theclip magazine 70240. The second layer 70248 of clips 70244 are storedabove the first layer 70246 of clips 70244 in a storage position fromwhich they cannot be ejected from the clip magazine 70240. Each of thefirst layer 70246 and second layer 70248 comprises three clips 70244,however, other embodiments are envisioned with more or less than threeclips. The first and second layers 70246 and 70248 are separated by adivider member, such as a divider plate 70249. The clip magazine 70240further comprises a top plate 70243 and biasing members 70242. The topplate 70243 rests on top of the second layer 70248 of clips 70244. Thebiasing members 70242 bias the top plate 70243 toward the top of thesecond layer 70248 of clips 70244 and, thus, bias the second layer 70248of clips 70244 toward the divider plate 70249. The divider plate 70249rests on top of the first layer 70246 of clips 70244 and a distalprotrusion 70232 of the feeder member 70230. The distal protrusion 70232extends above the feeder member 70230. Operation of the clip applier70200 is discussed in further detail below.

In use, the feeder member 70230 is translated distally to push the firstlayer 70246 of clips 70244 toward the end effector 70220 and out of theclip magazine 70240. As the first layer 70246 of clips 70244 is beingadvanced from the clip magazine 70240, the divider plate 70249 issupported by the distal protrusion 70232 of the feeder member 70230 andany of the clips 70244 which haven't been fully ejected from the clipmagazine 70240. Once the feeder member 70230 has advance all of theclips 70244 in the first layer 70246 out of the clip magazine 70240, thedivider plate 70249 is biased by the biasing members 70242 into a recess70233 in the feeder member 70230. The recess 70233 is defined betweenthe distal protrusion 70232 of the feeder member 70230 and a proximalprotrusion 70234 of the feeder member 70230 extending upward from theproximal end of the feeder member 70230. Once the divider plate 70249 isseated in the recess 70233, the feeder member 70230 and divider plate70249 can be retracted together proximally out of the clip magazine70240. After the feeder member 70230 and divider plate 70249 arecompletely retracted out of the clip magazine 70240, the second layer70248 of clips 70244 is biased by the biasing members 70242 into thefeeding position (i.e., where the first layer 70246 of clips 70244 usedto be). The feeder member 70230 and divider plate 70249 can be advancedtogether toward the end effector to eject the second layer 70248 ofclips 70244 from the clip magazine 70240. The reader will appreciatethat all of the clips 70244 in the first layer 70246 and/or second layer70248 are not ejected at the same time, rather, they are ejected one ata time to allow each clip 70244 to be sequentially crimped by the pairof jaws 70255 of the end effector 70220. The above being said, otherembodiments are envisioned in which more than one clip 70244 can beejected at a time.

FIG. 318 depicts a clip applier 70250 in accordance with at least oneembodiment. The clip applier 70250 comprises an elongate shaft 70260extending from a housing, a clip cartridge 70270 extending from theelongate shaft 70260, and an end effector 70280 extending from the clipcartridge 70270. The elongate shaft 70260 and the clip cartridge 70270define a shaft axis SA. The elongate shaft 70260 comprises a firstinwardly extending detent 70264 a and a second inwardly extending detent70264 b opposing the first inwardly extending detent 70264 a. The firstand second inwardly extending detents 70264 a and 70264 b extendinwardly toward the shaft axis SA and can flex outwardly away from theshaft axis SA when a force is applied thereto. The elongate shaft 70260further comprises a top notch 70262 a and a bottom notch 70262 bopposing the top notch 70262 a. The top notch 70262 a and the bottomnotch 70262 b are located in the distal end of the elongate shaft 70260.The clip cartridge 70270 is releasably attachable to the distal end ofthe elongate shaft 70260 as discussed in further detail below.

The clip cartridge 70270 comprises a top protrusion 70272 a and a bottomprotrusion 70272 b opposite the top protrusion 70272 a. The topprotrusion 70272 a and the bottom protrusion 70272 b extend from theclip cartridge 70270 away from the shaft axis SA. The clip cartridge70270 further comprises a first slot and a second slot 70274 b in theproximal end of the clip cartridge 70270. The first slot and the secondslot 70274 b oppose one another. The clip cartridge 70270 is configuredto slide into the inner diameter of the elongate shaft 70260 such thatthe top protrusion 70272 a slides into the top notch 70262 a, the bottomprotrusion 70272 b slides into the bottom notch 70262 b, the firstinwardly extending detent 70264 a engages the first slot of the clipcartridge 70270, and the second inwardly extending detent 70264 bengages the second slot 70274 b of the clip cartridge 70270 to attachthe clip cartridge 70220 to the elongate shaft 70260. After the clipcartridge 70270 is attached to the elongate shaft 70260, the elongateshaft 70260 and clip cartridge 70270 are fixedly coupled such that theycan rotate together about the shaft axis SA. Further, the clip cartridge70270 can be detached from the elongate shaft 70260 by a clinician whenthe clinician applies a distal force to the clip cartridge 70270 todisengage the first and second inwardly extending detents 70264 a and70264 b of the elongate shaft 70260 from the first slot and the secondslot 70274 b of the clip cartridge 70270.

Referring primarily to FIGS. 318 and 319, the end effector 70280comprises a first jaw 70280 a and a second jaw 70280 b configured tomove relative to each other between an open position (FIG. 318) and aclosed position (FIG. 319). To this end, the first jaw 70280 a and thesecond jaw 70280 b comprise openings at the proximal end thereof whichare configured to receive a pin 70290. The pin 70290 is rotatablycaptured within an opening 70276 in the clip cartridge 70270. The pin70290 defines a pin axis PA which is orthogonal to the shaft axis SA.The first jaw 70280 a and the second jaw 70280 b are rotatable relativeto each other about the pin axis PA. When the first jaw 70280 a and thesecond jaw 70280 b are in the open position (FIG. 318) a clip can bepositioned between the first jaw 70280 a and the second jaw 70280 b. Asthe first jaw 70280 a and the second jaw 70280 b are r towards theclosed position (FIG. 319) the clip is crimped between the first jaw70280 a and the second jaw 70280 b. The first jaw 70280 a and the secondjaw 70280 b are moved from the open position to the closed position by aclosure tube which cammingly engages the outer surfaces of the first jaw70280 a and the second jaw 70280 b as the closure tube moves distally.When the closure tube is retracted, the first jaw 70280 a and the secondjaw 70280 b are returned to the open position by a biasing member, orspring, which biases the first jaw 70280 a and the second jaw 70280 binto the open position. Other embodiments are envisioned where the firstjaw 70280 a and the second jaw 70280 b are movable from the closedposition to the open position by jaw cams on the first jaw 70280 a andthe second jaw 70280 b interacting with the closure tube, similar to jawcams 70124 a and 70124 b depicted in FIGS. 312-314, for example.

FIG. 320 depicts a clip applier 70300 in accordance with at least oneembodiment. The clip applier 70300 comprises a shaft 70310, an endeffector 70320 extending from the shaft 70310, a firing drive, and aclip magazine 70306. The clip magazine 70306 is built into the shaft70310 of the clip applier 70300 as depicted in FIG. 320. However, otherembodiments are envisioned where the clip magazine 70306 is releasablyattachable to the clip applier 70300. The shaft 70310 comprises openings70308 on either side of the shaft 70310 which allow a user of the clipapplier 70300 to access the clip magazine 70306. Other embodiments areenvisioned with only one opening in the shaft 70310 of the clip applier.The clip applier 70300 further comprises an outer tube 70302 that isslidable along the shaft 70310 of the clip applier 70300. The outer tube70302 is configured to slide along the shaft 70310 to cover the openings70308 in the shaft 70310. The clip magazine 70306 is configured to storea plurality of clips, such as clips 70304 therein. The clips 70304 areinsertable into the clip magazine 70306 through the openings 70308 whenthe outer tube 70302 is not obstructing the openings 70308, as depictedin FIG. 320. Once positioned in the clip magazine 70306, the clips 70304can be advanced out of the clip magazine 70306 into the end effector70320 by the firing member. In at least one embodiment, the clips 70304can be sequentially advanced out of the clip magazine 70306 into the endeffector 70320. When the outer tube 70302 is covering the openings70308, access to the clip magazine 70306 is prevented, and, if clips70304 have already been inserted into the clip magazine 70306, the outertube 70302 prevents the clips 70304 from exiting the clip magazine 70306through the openings 70308. Once all of the clips 70304 inside the clipmagazine 70306 have been advanced into the end effector 70320, the outertube 70302 can be retracted to allow a new set of clips to be insertedinto the clip magazine 70306. Further to the above, the outer tube 70302can be operably engaged with the firing member of the clip applier70300, such that, when the outer tube 70302 is retracted as depicted inFIG. 320, or at least partially retracted, the firing member cannot beactuated.

FIG. 322 depicts a clip applier 70300′. Clip applier 70300′ is similarto clip applier 70300 in many respects. The clip applier 70300′comprises an elongate shaft 70315 extending from a housing, anarticulation joint 70314 extending from the elongate shaft 70315, ashaft assembly 70310′ extending from the articulation joint 70314, anend effector 70320 extending from the shaft assembly 70310′, and anouter tube 70302′ positioned around the shaft assembly 70310′. Thearticulation joint 70314 connects the elongate shaft 70315 to the shaftassembly 70310′ so that the shaft assembly 70310′ can be articulatedrelative to the elongate shaft 70315. The shaft assembly 70310′comprises a proximal shaft portion 70311 extending from the articulationjoint 70314, a distal shaft portion 70312 extending from the proximalshaft portion 70311, and a hinge 70307. The distal shaft portion 70312further comprises a clip magazine 70306′. Other embodiments areenvisioned where the proximal shaft portion 70311 comprises the clipmagazine 70306′. The hinge 70307 allows the distal shaft portion 70312to rotate away from the proximal shaft portion 70311. The outer tube70302′ is configured to slide along the shaft assembly 70310′ between alocked position and an unlocked position when the proximal shaft portion70311 and distal shaft portion 70312 are aligned. More specifically,when the proximal shaft portion 70311 and distal shaft portion 70312 arealigned and the outer tube 70302′ is in the locked position, the distalshaft portion 70312 is prevented from rotating away from the proximalshaft portion 70311 about the hinge 70307. When the outer tube 70302′ isin the unlocked position, the distal shaft portion 70312 is capable ofrotating away from the proximal shaft portion 70311 about the hinge70307. Further to the above, when the distal shaft portion 70312 isrotated away from the proximal shaft portion 70311, an opening 70308′ inthe clip magazine 70306′ is exposed. The opening 70308′ allows clips70304′ to be inserted into the clip magazine 70306′.

Further to the above, a clip reloader 70350 can be utilized to insertthe clips 70304′ into the clip applier 70300′ as depicted in FIG. 322.The clip reloader comprises a housing 70352, a trigger 70354 movablerelative to the housing 70352, a feeder bar operably engaged with thetrigger 70354, an elongate shaft 70356 extending from the housing 70352,and a docking station 70360 extending from the elongate shaft 70356. Aplurality of clips 70304′ are removably stored in the elongate shaft70356. In one embodiment, the elongate shaft 70356 stores 20 clipswithin a six inch span of the elongate shaft 70356. Other embodimentsare envisioned with different numbers of clips and spans, for example.The clips 70304′ are advanced from the elongate shaft 70356 into thedocking station 70360 by the feeder bar when the trigger 70354 is movedtowards the housing 70352. The docking station 70360 comprises a cavity70358 configured to dock with the shaft assembly 70310′ of the clipapplier 70300′ when the distal shaft portion 70312 is rotated away fromthe proximal shaft portion 70311. When the docking station 70360 isdocked with the shaft assembly 70310′ of the clip applier 70300′, theclips 70304′ can be advanced form the elongate shaft 70356 into the clipmagazine 70306′ of the clip applier.

FIGS. 323-325 depict a different clip reloader 70400. The clip reloader70400 is similar to the clip reloader 70350 in many respects. The clipreloader 70400 comprises a housing 70410, a plurality of clips 70404stored inside the housing 70410, and a plunger 70402. The plunger 70402extends into and is movable relative to the housing 70410. The clips70404 are stacked vertically in the embodiment illustrated in FIGS. 323and 324; however, other embodiments are envisioned where the clips arestacked horizontally. A feeder block 70406 extends from the plunger70402 and is slidably engaged with the inside of the housing 70410. Thefeeder block 70406 comprises angled portions that support the backsideof the top-most clip in the clip stack as depicted in FIG. 323. Thehousing 70410 comprises a boss 70408 extending from the bottom of thehousing 70410, and a flexible ramp 70409 extending from the bottom ofthe boss 70408. The housing 70410 further comprises a cutout region70411. Docking the clip reloader 70400 with a clip applier is discussedin further detail below.

In various circumstances, the clip reloader 70400 is configured toinsert the clips 70404 into a clip applier, such as clip applier 70450,for example. The clip applier 70450 comprises a shaft 70460, an endeffector 70480 extending distally from the shaft 70460, and anarticulation joint 70470 extending proximally from the shaft 70460. Toalign the clip reloader 70400 with the clip applier 70450, the boss70408 docks with an opening 70464 in the shaft 70460 of the clip applier70450, the cutout region 70411 mates with the exterior of the shaft70460, and the flexible ramp 70409 extends into a clip slot 70462 of theclip applier 70450 as depicted in FIG. 325. The opening 70464 leads tothe clip slot 70462 which comprises an angled portion that receives theboss 70408 and flexible ramp 70409 of the clip reloader 70400. The clipslot 70462 further comprises a flat portion that facilitates theadvancement of the clips 70404 into the end effector 70480 of the clipapplier 70450. The operation of the clip reloader 70400 in conjunctionwith the clip applier 70450 is discussed in further detail below.

In use, after the clip reloader 70400 is docked with the clip applier70450, the plunger 70402 is moved towards the clip applier 70450 toadvance the clips 70404 from the housing 70410 into the angled portionof the clip slot 70462. The ramp 70409 supports and guides the clips70404 from the angled portion of the clip slot 70462 into the flatportion of the clip slot 70462. As illustrated in FIG. 325, the housing70410 of the clip reloader 70400 is positioned at an angle relative tothe longitudinal axis of the clip applier 70450 when the clip reloader70400 is docked with the clip applier 70450. Other embodiments areenvisioned where the housing 70410 is orthogonal, or at leastsubstantially orthogonal, to the clip applier 70450 when docked.Referring primarily to FIG. 325, the clip applier 70450 furthercomprises a flexible firing member 70465 positioned within a firing slot70466 located proximal to the clip slot 70462. After the clip reloader70400 is un-docked with the clip applier 70450, the flexible firingmember 70465 can move from the firing slot 70466 into the clip slot70462 to advance the clips 70404 into the end effector 70480. Once atleast one, or all, of the clips 70404 have been advanced into the endeffector 70480, the flexible firing member 70465 can be retracted fromthe clip slot 70462 into the firing slot 70466 and additional clips70404 can be loaded into the clip slot 70462 by the clip reloader 70400.

FIGS. 326-328 depict a clip applier 70500. The clip applier 70500comprises an elongate shaft 70570 (see FIG. 328) extending from ahousing, a shaft 70510 attachable to the elongate shaft 70570, an endeffector 70520 extending from the shaft 70510, and a clip magazine70530. The attachable shaft 70510 comprises an upper pivot link 70512and a lower pivot link 70514 extending distally therefrom. The endeffector 70520 comprises a first jaw 70521 a and a second jaw 70521 bmovable relative to each other between an open position and a closedposition about a pivot pin 70511. The pivot pin 70511 is constrainedwithin openings in the upper pivot link 70512 and the lower pivot link70514 of the shaft 70510. The clip magazine 70530 is removablypositioned within the attachable shaft 70510 and comprises a pluralityof clips 70532. The clip applier 70500 further comprises a closuresystem 70540 and a firing system 70550. The closure system 70540 and thefiring system 70550 are discussed in greater detail below.

The closure system 70540 comprises a proximal closure driver 70542comprising a threaded portion 70543, a distal closure driver 70566comprising a closure nut 70544, an upper closure hinge 70545 a, and alower closure hinge 70545 b. The proximal closure drive 70542 isconfigured to rotate in response to rotary motions generated inside thehousing of the clip applier. The closure drive 70542 transmitsrotational motion to the threaded portion 70543 which is threadablyreceived in the closure nut 70544. The closure drive 70542 can comprisea flexible portion to facilitate the transfer of rotational motion tothe closure nut 70544. The closure nut 70544 is rotatably constrainedwithin the shaft 70510 such that rotation of the threaded portion 70543in a first direction will result in translation of the nut 70544distally, and rotation of the threaded portion 70543 in a seconddirection—opposite the first direction—will result in translation of thenut 70544 proximally. The distal closure driver 70566 extends from theclosure nut 70544 and attaches to the upper closure hinge 70545 a andthe lower closure hinge 70545 b via a closure pin 70547. The closure pin70547 allows the upper and lower closure hinges 70545 a and 70545 b totranslate distally and proximally with the distal closure driver 70566while still being rotatable about the closure pin 70547. Further to theabove, the upper closure hinge 70545 a is rotatably engaged with aproximal portion 70523 a of the first jaw 70521 a, and the lower closurehinge 70545 b is rotatably engaged with a proximal portion 70523 b ofthe second jaw 70521 b. As illustrated in FIG. 326, the first jaw 70521a and the second jaw 70521 b cross over each other about the pivot pin70511 in a scissor like formation. Such an arrangement allows the firstjaw 70521 a and the second jaw 70521 b to move toward the open positionwhen the upper and lower closure hinges 70545 a and 70545 b aretranslated distally by the closure system 70540, and allows the firstjaw 70521 a and the second jaw 70521 b to move toward the closedposition when the upper and lower closure hinges 70545 a and 70545 b aretranslated proximally by the closure system 70540.

The clip applier 70500 further comprises a firing system 70550comprising a firing member 70560. The firing member 70560 istranslatable through the end effector between an unfired position and afired position in response to the rotary motions that drive the closuresystem 70540. Other embodiments are envisioned where the closure system70540 and the firing system 70550 are operated by two separate motorswithin the housing of the clip applier, for instance. The firing member70560 is configured to advance a clip 70532 from the clip magazine 70530into the first and second jaws 70521 a and 70521 b of the clip applier70500. As illustrated in FIG. 327, the clip magazine 70530 is at leastpartially supported by the closure system 70540. More specifically, abiasing member, such as leaf spring 70546, for example, biases the clips70532 toward the firing member 70560 and holds the clip magazine 70530in position. Other embodiments are envisioned where the closure system70540 can align, and/or guide, and/or lock the clip magazine 70530 intoplace within the shaft 70510. The embodiment depicted in FIGS. 326 and327 illustrates the closure system 70540 arranged around the clipmagazine 70530 to allow a larger space inside the shaft 70510 for theclip magazine 70530 and clips 70532; however, a closure system can haveany suitable arrangement. The closure system 70540 is discussed infurther detail below.

The threaded portion 70543 and closure nut 70544 of the closure system70540 allows for a more precise actuation of the first and second jaws70521 a and 70521 b when moving between the open position and the closedposition as compared to previous clip applier arrangements that utilizea translating closure tube or cam member. Rotary encoders and/or othersensors can be used in combination with the closure system 70540 toprovide even greater accuracy in determining the position of the firstand second jaws 70521 a and 70521 b.

Turning now to FIG. 328, the clip applier 70500 further compriseprotrusions 70513 and 70516 extending from the proximal end of the shaft70510. The protrusions 70513 and 70516 may be the same shape ordifferent shapes. The protrusions 70513 and 70516 are configured tolockingly engage slots 70572 a and 70572 b in the elongate shaft 70570of the clip applier 70500 to form a bayonet connection therebetween. Theslots 70572 a and 70572 b comprise L-shaped portions that lock theprotrusions 70513 and 70516 into place when the shaft 70510 is insertedinto and then rotated relative to the elongate shaft 70570. FIG. 328further depicts a clip 70532 located within the first jaw 70521 a andthe second jaw 70521 b. The clip 70532 and other embodiments of clipsfor use with a clip applier, such as clip applier 70500, are discussedin further detail below.

Turning now to FIGS. 329 and 330, the clip 70532 comprises a baseportion 70534, a first leg 70534 a extending from the base portion70534, and a second leg 70534 b extending from the base portion 70534and opposing the first leg 70534 a. The base portion 70534 can comprisea flexible material, such as plastic and/or any other suitable flexiblematerial, to allow the clip 70532 to flex between multiple positionswithout breaking or becoming plastically deformed in an unsuitablemanner. For example, the clip 70532 can be moved between a magazinestorage configuration, a pre-firing configuration, and a post-firingconfiguration as depicted in FIG. 330. The first leg 70534 a comprises areinforced region comprising a ridge 70535 a, and the second leg 70534 bcomprises a reinforced region comprising a ridge 70535 b. The ridges70535 a and 70535 b extend along at least a portion of the first leg70534 a and the second leg 70534 b, respectively. The ridges 70535 a and70535 b act as a rigid backbone to prevent, or at least substantiallyreduce, the deformation of the first leg 70534 a and the second leg70534 b during crimping. Other embodiments are envisioned where only oneof the first leg 70534 a and the second leg 70534 b comprises a ridge.The ridges 70535 a and/or 70535 b may be comprised of a rigid material,such as a fiberglass-filled and/or particle-filled plastic, for example,to prevent, or at least reduce, deflection of the first leg 70534 aand/or the second leg 70534 b when the clip 70532 is crimped. The clip70532 further comprises a locking portion, such as tooth 70536, forexample, extending from a portion of the first leg 70534 a. The tooth70536 lockingly engages the edges of an opening, or window, 70537 in thesecond leg 70534 b when the clip 70532 is crimped (see the post-firingconfiguration in FIG. 330). Such an arrangement allows the clip 70532 tostay in a crimped state after the clip 70532 has been released from thejaws of a clip applier. Further, the clip 70532 includes grip features,such as protrusions 70538, extending from the inside surfaces of thefirst and second legs 70534 a and 70534 b. The protrusions 70538 engagetissue clamped between the first and second legs 70534 a and 70534 bwhen the clip 70532 is crimped. The protrusions 70538 prevent, or atleast substantially reduce, the movement of the tissue relative to theclip 70532 after the clip 70532 is crimped around the tissue. Theprotrusions 70538 may be any number of shapes and sizes, such aspyramidal shapes, conical shapes, frustoconical shapes, for example,and/or any other suitable shape.

Turning now to FIGS. 331-334, a different clip 70580 for use with a clipapplier is depicted. The clip 70580 is similar to clip 70532 in manyrespects. That said, the base 70534 of the clip 70580 comprises a stressrelief notch 70588 on the side of the base 70534 opposite the first andsecond legs 70534 a and 70534 b. In use, the stress relief notch 70588allows the first and second legs 70534 a and 70534 b to flex inwardlyand then outwardly a number of times without being plastically deformedin an unsuitable manner. However, in various circumstances, the clip70580 can be configured to yield, or deform plastically, when the clip70580 is sufficiently compressed. Such designed or controlled yielding,in various instances, can help the clip 70580 fold into the desiredshape.

FIGS. 335-344 depict a clip applier 70600. Turning now to FIG. 336, theclip applier 70600 comprises a shaft 70610 extending from a housing, anend effector 70605 extending from the shaft 70610, and a rotatable clipmagazine 70650. The end effector 70605 comprises a first jaw and asecond jaw that are movable relative to each other between an openposition and a closed position, similar to the first jaw 70123 a and thesecond jaw 70123 b of the clip applier 70100 discussed above. Therotatable clip magazine 70650 is rotatably and slidably supported withinthe clip applier 70600. More specifically, the rotatable clip magazine70650 is rotatable about shaft axis SA and translatable along shaft axisSA. The shaft axis SA is defined by the shaft 70610. Further detailregarding how the clip magazine 70650 is supported within the clipapplier 70600 is provided below.

Referring to FIG. 335, the rotatable clip magazine 70650 comprises abody portion 70652 including five sides, each of which comprises a clipchannel 70656 configured to removably store a clip 70654 therein. Thebody portion 70652 further comprises an opening 70653 that extendsthrough the body portion 70652. In the illustrated embodiment, the bodyportion 70652 is pentagonal in shape, for example; however, otherembodiments are envisioned in which the opening 70653 comprisesdifferent shapes to allow for more than or less than five clip channels70656 and, therefore, more than or less than five clips 70654 stored inthe rotatable clip magazine 70650. In at least one embodiment, the clips70654 comprise a clip width of 0.080″, a clip thickness of 0.03″, and aclip length of 0.310″ (for a Lig 5 Clip) or 0.315″ (for an ER320 Clip),for example; however, clips having any suitable size can be used.Moreover, it is envisioned that the clips stored in the clip magazine70650 will have the same, or at least substantially the same size;however, alternative embodiments are envisioned in which clips havingdifferent sizes may be stored in the same clip magazine. Further, in atleast one embodiment, the overall diameter of the entire rotatable clipmagazine 70650 is 0.996″, for example; however, the clip magazine 70650can have any suitable diameter—including diameters which can permit theclip magazine 70650 to be inserted through a trocar. The rotatable clipmagazine 70650 further includes a clocking portion, such as teeth 70658,for example, extending proximally from the clip magazine 70650. The clipapplier 70600 comprises several drives and drivers which define themotion and/or operating sequence of the clip applier 70600, as describedin further detail below.

Referring again to FIG. 336, the clip applier 70600 further comprises aclosure tube 70620, a feeder member 70630, and a firing member 70640.The closure tube 70620 comprises a closure drive 70625 extendingproximally from the closure tube 70620. The closure drive 70625 extendsthrough the opening 70653 in the clip magazine 70650 and is operablyengaged with an actuator inside the housing of the clip applier 70600.The clip magazine 70650 is supported on at least a portion of theclosure drive 70625. The closure tube 70620 is at least partiallysupported and aligned within a recess in the shaft 70610. The closuretube 70620 is movable between a plurality of positions, such as a fullyretracted position, a home position, and a fully advanced position (seeFIGS. 336 and 337). Similar to the crimping drive 70180 of the clipapplier 70100, the closure tube 70620 is configured to move the firstjaw and the second jaw of the end effector 70605 toward and away fromeach other. When the closure tube 70620 moves distally, the closure tube70620 cammingly engages the first and second jaws to move the first andsecond jaws to the closed position and, when the closure tube 70620moves proximally, the closure tube 70620 engages jaw cams on each of thefirst and second jaws to move the first and second jaws to the openposition. That said, any suitable jaw opening and closing arrangementcould be used.

The feeder member 70630 is aligned with one of the clip channels 70656of the rotatable clip cartridge 70650, and is configured to advance aclip 70654 out of the clip channel 70656 that is aligned with the feedermember 70630 toward the end effector 70605. The feeder member 70630 istranslatable linearly through the clip applier 70600 by a feeder gear70638 and a feeder drive 70635 which are operably engaged with a rackportion of the feeder member 70630. The feeder drive 70635 comprises apinion gear 70637 at the distal end thereof which is operably engagedwith the feeder gear 70638 such that, as the feeder drive 70635 isrotated, the feeder member 70630 is translated linearly through the clipapplier 70600. The feeder drive 70635 is operably engaged with a firstmotor inside the housing of the clip applier 70600. The first motortransmits rotational motion to the feeder drive 70635. Similar to theoperation of the feeder member 70630, the firing member 70640 istranslatable linearly through the clip applier by a firing gear 70648and a firing drive 70645 which are operably engaged with a rack portionof the firing member 70640. The firing drive 70645 comprises a piniongear 70647 on the distal end thereof which is engaged with the firinggear 70648 such that, as the firing drive 70645 is rotated, the firingmember 70640 is translated linearly through the clip applier 70600.Further, the firing drive 70645 is operably engaged with a second motorinside the housing of the clip applier 70600. The second motor transmitsrotational motion to the firing drive 70645. Other embodiments areenvisioned where the feeder drive 70635 and the firing drive 70645 arerotatable by the same motor utilizing a transmission. Further, otherembodiments are envisioned, and are described further below, where thefeeder member 70630 and the firing member 70640 translate togetherthrough the clip applier 70600. Operation of the feeder member 70630 andfiring member 70640 are also described in greater detail below.

Referring primarily to FIG. 336, the firing member 70640 comprises adistal portion 70640 a extending therefrom that is configured to advancea clip 70654 into the end effector. The shaft 70610 further includes aground portion 70612 mounted to the shaft 70610 and aligned with theclip magazine 70650. The ground portion 70612 is mounted to the shaft70610 such that the ground portion 70612 is not movable, translatable,and/or rotatable relative to the shaft 70610. The ground portion 70612includes a clocking portion, such as teeth 70614, for example, extendingdistally therefrom as illustrated in FIG. 338. The teeth 70614 of theground portion 70612 are aligned, or at least substantially aligned,with the teeth 70658 of the rotatable clip magazine 70650. Further, theground portion 70612 supports a biasing member, such as spring 70616,for example, thereon. The spring 70616 biases the clip magazine 70650distally toward the closure tube 70620 and the end effector 70605, asillustrated in FIG. 337. Other embodiments are envisioned where thespring comprises a leaf spring and the clip applier 70600 furthercomprises a track and the leaf spring can be configured to both indexthe clip magazine 70650 and prevent the clip magazine 70650 from counterrotation. In any event, the rotation of the clip magazine 70650 aboutthe shaft axis SA and translation of the clip magazine 70650 along shaftaxis SA is described in further detail below.

Referring primarily to FIG. 335, the closure tube 70620 includesclocking channels 70622 located radially around the closure drive 70625.The closure drive 70625 rotatably and slidably supports the rotatableclip magazine 70650 thereon as discussed above. The clocking channels70622 are engaged with protrusions within the opening 70653 of the clipmagazine 70650 to rotatingly lock the clip magazine 70650 into placerelative to the closure tube 70620 when the closure tube is in the homeposition or the fully advanced position. When the closure tube 70620 ismoved to the fully retracted position, as illustrated in FIG. 336, thespring 70616 moves/biases the clip magazine 70650 toward the closuretube 70620 resulting in the clocking channels 70622 becoming disengagedfrom the protrusions within the opening 70653 of the clip magazine70650. As such, the clip magazine 70650 can rotate freely about shaftaxis SA. Further, when the closure tube 70620 is moved to the fullyretracted position, the teeth 70658 of the clip magazine 70650 engagethe teeth 70614 of the ground portion 70612 to rotate (i.e., cycle) theclip magazine 70650. More specifically, the teeth 70658 and the teeth70614 are structured to rotate the clip magazine 70650 about the shaftaxis SA a predefined amount of degrees based on the spacing and anglesof the teeth 70658 relative to the teeth 70614. The reader willappreciate that the spacing and angles of the teeth 70658 relative tothe teeth 70614 can be designed to generate a suitable degree ofrotation for the clip magazine 70650 about shaft axis SA. In theembodiment depicted in FIGS. 335-337, the teeth 70658 and the teeth70614 are spaced and aligned such that, when they are engaged, the clipmagazine 70650 rotates 72 degrees to align an adjacent clip 70654 withthe feeder member 70630. After the clip magazine 70650 is cycled, theclosure tube 70620 can be moved distally from the fully retractedposition to the home position (FIG. 337) resulting in the clockingchannels 70622 engaging the protrusions in the opening 70653 of the clipmagazine 70650 to lock the rotation of the clip magazine 70650 asdiscussed above. Usage of the clip applier 70600 to advance, form, andfire a clip 70654 is describe in further detail below.

As mentioned above, the feeder member 70630 and firing member 70640 canbe translatable together. For simplicity, FIGS. 339-344 illustrate thefunctions of clip applier 70600 where the feeder member 70630 and firingmember 70640 move together to feed and fire a clip 70654 from therotatable clip magazine 70650. Turning now to FIGS. 339 and 340, a clip70654 is advanced from the rotatable clip magazine 70650 into engagementwith a biasing member, such as a leaf spring 70624, for example, of theclosure tube 70620 by the feeder member 70630. The leaf spring 70624biases and guides the clip 70654 onto the top of the firing member70640, as illustrated in FIG. 340. When the firing member 70640 andfeeder member 70630 are retracted, the clip 70654 is moved furtherdownward by the leaf spring 70624 and seated around pre-form features,such as protrusions 70608, for example, depicted in FIG. 341.Protrusions 70608 can be similar to protrusions 70126 a and 70126 bdescribed above (See FIGS. 309 and 310). One protrusion 70608 is locatedon one jaw of the end effector 70605, and another protrusion 70608 islocated on another jaw of the end effector 70605.

When the closure tube 70620 is in the fully retracted position,referring to FIG. 342, the jaws of the clip applier 70600 are in theopen position and the protrusions 70608 expand the clip 70654 from astorage configuration into a firing configuration—similar to theexpansion of clip 70140 described above in connection with FIGS. 309 and310. When the closure tube 70620 is moved to the fully retractedposition, as described above, the rotatable clip magazine 70650 isrotated (i.e., cycled) about the shaft axis SA to position another clip70654 into alignment with the feeder member 70630. Turning to FIG. 343,the firing member 70640 can be moved toward the end effector 70605 toadvance the clip 70654 over the protrusions 70608 and into the endeffector 70605. As discussed above in connection with protrusions 70126a and 70126 b, the protrusions 70608 can comprise angled portions thatallow the clip 70654 to slide over the protrusions 70608 when advanceddistally by the firing member 70640. Once the clip 70654 is positionedin the end effector 70605, the closure tube 70620 can be moved to thefully advanced position (FIG. 344) to move the jaws from the openposition to the closed position to crimp the clip 70654 positionedbetween the jaws.

Because the feeder member 70630 and the firing member 70640 translatetogether, further to the above, the feeder member 70630 advances anotherclip 70654 (i.e., the clip that was rotated into position when theclosure tube 70620 was fully retracted) from the clip cartridge 70650down onto the firing member 70654 with the aid of the leaf spring 70624,as discussed above, when the firing member 70640 advances a clip 70654into the end effector 70605. Again, the firing member 70640 and thefeeder member 70630 can be retracted to allow the new clip 70654 to bebiased downward by the leaf spring 70624 and seated around theprotrusions 70608. The new clip 70654 can then be expanded to the firingconfiguration as clip magazine 70650 is cycled, and then the new clip70654 can be advanced into the end effector 70605 for crimping asdiscussed above. The process discussed above can be repeated until theclip magazine 70650 has been spent. The reader will appreciate that theclosure tube 70620 can be moved between the home position (FIGS. 340 and341) and the fully advanced position (FIG. 344) to crimp and release aclip 70654 within the end effector 70605 without cycling the clipmagazine 70650. This allows the jaws of the end effector 70605 to movebetween the open and closed positions without cycling the clip magazine70650 and/or ejecting another clip from the clip magazine 70650.

FIG. 345 depicts a clip applier 70700 in accordance with at least oneembodiment. The clip applier 70700 comprises a shaft 70710 extendingfrom a housing, an end effector 70705 extending from the shaft 70710,and a clip cartridge 70720 that is releasably attachable to the clipapplier 70700. The end effector 70705 comprises a first jaw and a secondjaw movable relative to each other, similar to the first and second jaws70123 a and 70123 b discussed above. The clip applier 70700 furthercomprises a firing system 70730 that comprises a rotatable drive 70732which is operably responsive to a motor inside the housing of the clipapplier 70700. The rotatable drive 70732 comprises a threaded portion.The firing system 70730 further includes a firing member 70736 and afiring nut 70734. The firing nut 70734 is threadably received on thethreaded portion of the rotatable drive 70732. The firing nut 70734 isrotatably constrained within the clip applier 70700 such that therotation of the rotatable drive 70732 translates the firing nut 70734through the clip applier 70700. The firing member 70736 is engaged withthe firing nut 70734 and translates into the first and second jaws ofthe end effector 70705 in response to translation of the firing nut70734 by the rotatable drive 70732. Attachment of the clip cartridge70720 to the clip applier 70700 is described in greater detail below.

The clip applier 70700 further comprises a docking region, or recess70714, in the distal end of the clip applier 70700, as illustrated inFIG. 345. The clip cartridge 70720 comprises a body portion 70722 thatis slidably receivable in the recess 70714 of the clip applier 70700. Alocking feature 70728 extends proximally from the clip cartridge 70720.The locking feature 70728 includes an angled surface 70728 a at theproximal end thereof and a detent 70728 b extending downwardly, althoughthe locking feature 70728 can include any suitable arrangement. Thelocking feature 70728 engages a protrusion 70712 of the shaft 70710 whenthe clip cartridge 70720 is docked within the recess 70714. Morespecifically, the angled surface 70728 a slides over the protrusion70712 and the downwardly extending detent 70728 b locks into placeproximal to the protrusion 70712, thus locking the clip cartridge 70720to the clip applier 70700. In such instances, the locking feature 70728deflects as the angled surface 70728 a slides over the protrusion 70712and then resiliently returns to, or at least toward, its undeflectedconfiguration, when the detent 70728 b locks into place. A sufficientdistal pulling motion can cause the locking feature 70728 to deflect andrelease the clip cartridge 70720 from the clip applier 70700. Operationof the clip applier 70700 is described in further detail below.

The clip cartridge 70720 further comprises a ramp portion 70721, aplurality of clips 70724 positioned in a stack, and biasing members,such as springs 70726, for example. The clips 70724 are biased towardthe ramp portion 70721 by the springs 70726. In fact, the top clip 70724in the stack of clips is biased into the ramp portion 70712 by thesprings 70726. When the clip cartridge 70720 is docked with the clipapplier 70700, as discussed above, the ramp portion 70721 aligns with afeeder drive 70740 of the clip applier 70700. The feeder drive 70740 isoperably responsive to an actuator within the housing of the clipapplier 70700. The feeder drive 70740 is configured to reciprocatinglyactuate into the ramp portion 70721. To accommodate an angled portionwithin the ramp portion 70721 the feeder drive 70740 can be flexible.The feeder drive 70740 feeds the top clip 70724 in the stack of clipsthrough the ramp portion 70721 and into the end effector 70720. Once inthe end effector 70705, the clip 70724 can be advanced further distallyinto the first and second jaws of the end effector 70705 by translationof the firing member 70736, as discussed above. Once located in thefirst and second jaws, the clip 70724 can be crimped by a crimpingdrive. The feeder drive 70740 can be retracted, allowing another clip70724 to be biased into the ramp portion 70721. The feeder drive 70740can advance the new clip 70724 through the ramp portion 70721 and intothe first and second jaws of the end effector 70705 as discussed above.The process discussed above can be repeated until all of the clips 70724in the clip cartridge 70720 have been depleted, and/or until a suitablenumber of clips have been applied to the tissue.

FIG. 346 depicts a clip applier system 70750 in accordance with at leastone embodiment. The clip applier system 70750 comprises a shaft 70760extending from a housing, the clip applier 70250 depicted in FIG. 318positioned at least partially within the shaft 70760, and the rotatableclip magazine 70650 depicted in FIGS. 335-344 positioned within theshaft 70760. A feeder member is configured to advance the clips 70654from the rotatable clip magazine 70650—one at a time—into the first andsecond jaws 70280 a and 70280 b of the clip applier 70250. Once locatedwithin the first and second jaws 70280 a and 70280 b, the clip 70654 canbe crimped as discussed above in relation to FIGS. 318 and 319. Once theclip 70654 is crimped, the rotatable clip magazine 70650 can be cycled(i.e., rotated) to position another clip 70654 for advancement into thefirst and second jaws 70280 a and 70280 b of the clip applier 70250 bythe feeder member. This process can continue until all of the clips70654 in the rotatable clip magazine 70650 have been spent. After all ofthe clips 70654 have been spent, the rotatable clip magazine 70650 canbe replaced with another rotatable clip magazine 70650 containing a fullcomplement of clips 70650. Other embodiments are envisioned where thespent rotatable clip magazine 70650 can be detached from the clipapplier system 70750, reloaded with clips 70650, and then re-attached tothe clip applier system 70750 for further use.

Turning now to FIGS. 348 and 349, an articulation joint 70800 for usewith a clip applier is illustrated. The articulation joint 70800releasably couples a clip cartridge 70820 to a shaft 70810 of a clipapplier. The shaft 70810 comprises an articulation pivot, or pivot pin70814, extending from the inside of the shaft 70810. The pivot pin 70814comprises a base portion 70817, a first leg 70814 a extending from thebase portion 70817, and a second leg 70814 b extending from the baseportion 70817 and opposing the first leg 70814 a. The first and secondlegs 70814 a and 70814 b extend away from each other. The first leg70814 a comprises a first detent, or shoulder, 70816 a extendingoutwardly from the first leg 70814 a, and the second leg 70814 bcomprises a second detent, or shoulder, 70816 b extending outwardly fromthe second leg 70814 b. The clip cartridge 70820 comprises a firstopening 70822 and, also, a second opening 70824 positioned adjacent andlateral to the first opening 70822. The first opening 70822 is centeredin the clip cartridge 70820 and rotatably receives the pivot pin 70814when the clip cartridge 70820 is attached to the shaft 70810. The firstleg 70814 a and the second leg 70814 b flex towards each other when thefirst opening 70822 is slid onto the pivot pin 70814 due to angledsurfaces at the end of each of the first leg 70814 a and second leg70814 b (See FIG. 349). As the first leg 70814 a and second leg 70814 bflex toward each other, the pivot pin 70814 can slide through the firstopening 70822 until the first and second detents 70816 a and 70816 bclear the first opening 70822, as illustrated in FIG. 349. Once thefirst and second detents 70816 a and 70816 b clear the first opening70822, the first and second legs 70814 a and 70814 b can expand to lockthe clip cartridge 70820 to the pivot pin 70814. More specifically, thebottom surfaces of the first and second detents 70816 a and 70816 b reston an outer surface 70826 of the clip cartridge 70822 preventing theclip cartridge 70820 from being detached from the pivot pin 70814 unlessa sufficient force is applied that exceeds a predetermined, or designed,force threshold. The reader will appreciate that, with force, a user ofthe clip applier can attach and detach the clip cartridge 70820 to theshaft 70810. Articulation of the clip cartridge about the pivot pin70814 is described in further detail below.

The clip applier depicted in FIGS. 348 and 349 further comprises arotatable output 70830 that is operably responsive to a motor locatedwithin the housing of the clip applier. The rotatable output 70830 isthreadably engaged with a threaded portion 70834 of an articulation bar70832. Rotation of the rotatably output 70830 in a first directiontranslates the articulation bar 70832 distally, and rotation of therotatable output 70830 in a second, or opposite, direction translatesthe articulation bar 70832 proximally. The articulation bar 70832comprises a downwardly extending protrusion 70836 that is slidablyreceived in a slot 70812 defined in the shaft 70810. The protrusion70836 and slot 70812 guide the articulation bar 70832 as thearticulation bar 70832 translates and limit relative lateral motionbetween the articulation bar 70832 and the shaft 70810. The articulationbar 70832 further comprises an upwardly extending protrusion 70838 whichis received in the second opening 70824 of the clip cartridge 70820 whenthe clip cartridge 70820 is attached to the shaft 70810. In use, thedistal translation of the articulation bar 70832 will rotate the clipcartridge 70820 about the pivot pin 70814 in a first direction and theproximal translation of the articulation bar 70832 will rotate the clipcartridge 70820 about the pivot pin 70814 in a second, or opposite,direction. The articulation bar 70832 can be flexible to allow thearticulation bar 70832 to flex as needed when the clip cartridge 70820is articulated about the pivot pin 70814.

FIG. 350 depicts a clip applier 70900 in accordance with at least oneembodiment. The clip applier 70900 comprises an elongate shaft 70910, anarticulation joint 70920, and a distal head 70930. The articulationjoint 70920 extends from the elongate shaft 70910 and the distal head70930 extends from the articulation joint 70920. The distal head 70930comprises a distal shaft 70932 attached to the articulation joint 70920,an end effector 70936 including a first jaw 70936 a and a second jaw70936 b, and a clip cartridge 70934. The first jaw 70936 a and secondjaw 70936 b are movable relative to each other between open and closedpositions by any suitable drive system, such as the drive systemsdisclosed herein, for example. The clip cartridge 70934 stores aplurality of clips which can be advanced into the end effector 70936 andcrimped by the first jaw 70936 a and the second jaw 70936 b. The clipcartridge 70934 is removably attachable to the distal shaft 70932 via akeying arrangement 70938. Other embodiments are envisioned where theclip cartridge 70934 is not removably attachable to the distal shaft70932. The elongate shaft 70910 defines a first roll axis RA₁ and thedistal head 70930 defines a second roll axis RA₂. The elongate shaft70910 and the distal head 70930 are articulable relative to each otherabout articulation axis AA via the articulation joint 70920. Thearrangement depicted in FIG. 350 is attachable—via the elongate shaft70910—to a plurality of clip applier handle types, such as, a standardhandle (i.e., a wand grip) and/or a pistol grip handle, for example.Depending on the type of handle that is attached to the elongate shaft70910, different actuations of, or within, the handle may performdifferent actuations of the arrangement depicted in FIG. 350 about thefirst roll axis RA₁, the second roll axis RA₂, and the articulation axisAA. These actuations are described in further detail below.

If the elongate shaft 70910 is attached to a standard handle (i.e., awand handle), referring still to FIG. 350, the elongate shaft 70910, thearticulation joint 70920, and the distal head 70930 are all rotatableabout the first roll axis RA₁ by the clinician rotating the wand handle.Further, a rotary knob on the wand handle is operably engaged with theelongate shaft 70910, through an electric motor and/or control system,for example, such that manually rotating the rotary knob will result inthe distal head 70930 rotating about the second roll axis RA₂. Further,articulation of the distal head 70930 relative to the elongate shaft70910 about articulation axis AA is driven by an articulation driveroperably engaged with a motor housed within the wand handle, forexample. If the elongate shaft 70910 is attached to a pistol griphandle, such as the handle 700 discussed above, for example, theelongate shaft 70910, the articulation joint 70920, and the distal head70930 are all rotatable about the first roll axis RA₁ by a rotary knob,for example. Further, the distal head 70930 is rotated about the secondroll axis RA₂ by a dedicated motor within the pistol grip handle.Further still, articulation of the distal head 70930 relative to theelongate shaft 70910 about articulation axis AA is induced by anarticulation driver operably engaged with a motor housed within thepistol grip handle. The reader should appreciate that, depending on thetype of handle attached to the arrangement depicted in FIG. 350,rotation of the elongate shaft 70910 about the first roll axis RA₁ canbe accomplished by rotating the entire handle manually, rotation of arotary knob engaged with the elongated shaft, and/or by a dedicatedmotor inside the handle. Further, the rotation of the distal head 70930about the second roll axis RA₂ can be accomplished by rotation of arotary knob engaged within the elongate shaft 70910 or by a dedicatedmotor inside the handle.

A clip applier jaw assembly 70950, or half of the jaw assembly 70950,and a clip leg 70954 of a clip are illustrated in FIG. 351. As can beseen in FIG. 351, the clip applier jaw assembly 70950 comprises a firstjaw 70950 a which includes a base 70952, a first leg 70952 a extendingfrom the base 70952, and a second leg 70952 b extending from the base70952. The first leg 70952 a and second leg 70952 b oppose one anotherand define a receiving area 70953 therebetween. The clip leg 70954 isreceived in the receiving area 70953 but, notably, part of the clip leg70954 cross-section is not positioned within the receiving area 70953.Thus, only portions of the clip leg 70954 cross-section are supported bythe first jaw 70950 a. Other arrangements exist where the receiving area70953 is substantially the same depth and width as the clip leg 70954 ofthe clip such that all, or at least substantially all, of thecross-section of the clip leg 70954 is positioned within the receivingarea 70953 and supported by the first jaw 70950 a.

A clip applier jaw assembly 70960 is depicted in FIG. 352. The clipapplier jaw assembly 70960 comprises a first jaw 70960 a which includesa base 70962, a first leg 70962 a, a second leg 70962 b, and a receivingarea 70963 which receives a first clip leg 70964 of a clip. The firstleg 70962 a of the first jaw 70960 a extends from the base portion 70962beyond the first clip leg 70964 when the first clip leg 70964 is seatedin the receiving area 70963. The second leg 70962 b of the first jaw70960 a extends from the base portion 70962 and terminates prior to theend of the first clip leg 70964 such that only a portion of the firstclip leg 70964 is supported by the second leg 70962 b of the first jaw70960 a.

The clip applier jaw assembly 70960 further comprises a second jaw 70960b positioned opposite, or opposing, the first jaw 70960 a. The secondjaw 70960 b comprises a base 70962′, a first leg 70962 a′, a second leg70962 b′, and a receiving area 70963′ which receives a second clip leg70964′ of the clip. The second jaw 70960 b opposes the first jaw 70960 asuch that the first leg 70962 a of the first jaw 70960 a is aligned withthe first leg 70962 a′ of the second jaw 70960 b, and the second leg70962 b of the first jaw 70960 a is aligned with the second leg 70962 b′of the second jaw 70960 b. The second leg 70962 b′ of the second jaw70960 b extends from the base portion 70962′ beyond the second clip leg70964′ of the clip when the second clip leg 70964′ is seated in thereceiving area 70963′. Further, the first leg 70962 a′ of the second jaw70960 b extends from the base portion 70962′ and terminates prior to theend of the second clip leg 70964′ such that only a portion of the secondclip leg 70964′ is supported by the first leg 70962 a′ of the second jaw70960 b.

When the first jaw 70962 a and the second jaw 70962 b of the clipapplier jaw assembly 70960 are in a closed configuration, as depicted inFIG. 353, the first leg 70962 a of the first jaw 70960 a supports theentire first clip leg 70964 of the clip and, also, a portion of thesecond clip leg 70964′ of the clip. Further, the second leg 70962 b′ ofthe second jaw 70960 b supports the entire second clip leg 70964′ of theclip and, also, a portion of the first clip leg 70964 of the clip.Because the first leg 70962 a of the first jaw 70960 a and the secondleg 70962 b′ of the second jaw 70960 b are opposite one another, thecross-sections of the first clip leg 70964 and the second clip leg70964′ are supported by both the first jaw 70960 a and the second jaw70960 b—along at least a portion of the leg lengths. Such an arrangementprevents, or at least inhibits, the clip from twisting when the clip iscrimped.

Referring to FIG. 354, the clip leg 70954 is seated within the firstclip jaw 70950 a of the clip applier jaw assembly 70950 but is notprevented from being slid longitudinally within the clip applier jawassembly 70950. In accordance with at least one embodiment, such as theclip applier jaw assembly 70960, for example, the first jaw 70960 aand/or the second jaw 70960 b comprise a clip ejection preventionfeature, such as distal stop 70966. The distal stop 70966 prevents theclip 70964 from sliding out of the distal end of the first jaw 70950 aand/or the second jaw 70950 b of the clip applier jaw assembly 70960.Other clip applier jaw shapes and guidance features configured tocontrol the position of the clip, and/or prevent the unintentionaldropping and/or ejection of the clip from the clip applier, arediscussed in greater detail below.

As discussed above, the jaws of a clip applier, or “clip jaws”, are usedto deform the clips. As the reader should appreciate, the clip jawsthemselves undergo stresses and strains and, in some instances, can beplastically deformed. Clip jaws designed to resist plastic deformationduring use may comprise clip jaws which vary in thickness, width, and/orclip path depth along the clip jaw lengths in order to improve thestiffness in a lap clip applier, for example. Further, a proximalportion of one of the clip applier jaws can comprise a protruding bar(i.e., a tongue portion) and a proximal portion of the other clipapplier jaw can comprise a recess (i.e., a groove portion) such that theprotruding bar is seated in the recess when the clip applier jaws areclosed. Such an arrangement provides for superior jaw resilience tovertical skewing and/or twisting of the clip applier jaws relative toeach other during crimping of a clip. Improved clip retention structuresare discussed in further detail below.

In at least one embodiment, the clip applier jaws may comprise a clipretention channel, or recess, to allow a clip to be advanced into theclip applier jaws via a feeder member from below. The feeder memberincludes a flexible drive plate that is retracted when the clip applierjaws are actuated (i.e., moved from an open position to a closedposition) and is extended into the distal end of the clip applier jawsto hold the clip in a distal position until the clip applier jaws areactuated. Further, the feeding member prevents any further clips frominadvertently advancing into the clip applier jaws until the feedermember is retracted to retrieve and advance the next clip. Clip applierjaws including a distal retaining feature are discussed in greaterdetail below.

In at least one embodiment, the clip applier jaws each comprise a distalretaining feature, such as a ledge, for example, that extends above aguidance trough in the clip applier jaws. The guidance trough maycomprise retention features, such as recesses, for example, on thedistal end thereof which mate with protrusions on the clip to allow theclip to remain in a distal position within the clip applier jaws withoutneeding to be held into place by a firing member and/or feeder member.The construction and manufacturing of certain clip applier jaws isdiscussed in greater detail below.

In various embodiments, the clip applier jaws are manufactured using atwo part method where at least the distal portions of the clip applierjaws are metal injection molded (MIM) within an injection mold. Incertain instances, the injection mold comprises two sides which aretranslatable toward and away from each other along a parting axis andthe interface between the two mold halves is often planar, or at leastsubstantially planar, and is often called a “parting plane”. In at leastone such instance, the parting plane is perpendicular to the axis of aclip trough of the clip applier jaws formed within the injection mold.Such an arrangement allows stiffening features, such as a rail, forexample, to be designed onto the back side of the clip applier jaws,friction or holding features within the clip trough, and/or the distalholding features discussed above, for instance. Using a MIM process mayoften require the clip applier jaws to be machined, ground, and/orpolished, for example, after being removed from the injection mold. Theclip applier jaws are then either pivotally pined together and/or weldedpivotally to the connection features of an end effector. By using MIM toproduce certain portions of the jaws, the cost to produce the jaws canbe reduced as inexpensive manufacturing methods can be utilized for theconnection features, as opposed to using MIM to produce the entire clipapplier jaws. Further, the clip applier jaws can be independentlymanufactured using MIM and then welded to a spring based interconnectionclip. Moreover, independently manufactured clip applier jaws that arethereafter assembled together allows for the clip applier jaws to have ametallic clip guidance track to be built into the lateral inside facingportion of the clip applier jaws. The independently manufactured clipapplier jaws using MIM may further comprise distal clip retentionfeatures, such as ledges, for example, which prevent the unintentionalejection of a clip from the distal end of the clip applier jaws. Suchdistal clip retention features can extend above the primary face of theclip applier jaws owing to these MIM processes.

As discussed above, and as described in greater detail below, certainclip appliers are configured to be inserted into a patient through apassage defined in a trocar. That said, the clip jaws of many clipappliers are wider than the trocar passage when they are in their openconfiguration. Described below are various systems that can beincorporated into a clip applier to facilitate the insertion of the clipapplier through the trocar passage.

Referring to FIG. 356, a graph 71000 depicts the movements of a cammember and a feeder/firing member of a clip applier, such as the clipapplier 70100, for example. The cam member is similar to cam member70180 and the feeder shoe is similar to firing member 70165 illustratedin FIGS. 309-314, for example. In order to configure the clip applier70100 in a trocar-insertion configuration, the cam member is moved to afully advanced position to close the jaws of the clip applier and thefeeder shoe is moved to a fully retracted position. In variousinstances, the clip applier comprises a control system including abutton which, when depressed, places the clip applier in itstrocar-insertion configuration. In at least one instance, the controlsystem operates the one or more electric motors of the clip applier toconfigure the drive systems as described above. At such point, the clipapplier is ready to be inserted into the patient through the trocar.Once inserted into the patient, the button can be pressed again and, inresponse thereto, the control system will retract the cam member to afully retracted position and open the jaws of the clip applier. Thisbutton can be pressed repeatedly to toggle the configuration of the clipapplier as needed. Such an arrangement is also useful to remove the clipapplier from the patient through the trocar. The reader shouldappreciate that the opening and closing of the jaws via the button willnot affect the other functions of the clip applier such as advancing aclip, forming a clip, and/or ejecting a clip from the clip magazine.

Once the clip applier has been inserted through the trocar and thebutton has been actuated a second time (i.e., the jaws are open),further to the above, a firing button can be pressed resulting in thefeeder shoe advancing to a fully advanced position. A clip will beadvanced with the feeder shoe as described above in relation to clipapplier 70100 (FIGS. 309-314), for instance. The feeder shoe can then beretracted to a fully retracted position and the cam member can beadvanced to the fully advanced position to form the clip around tissueof the patient, as also described above. The cam member can then beretracted to the fully retracted position to release the clip and thetissue. Once all of the clips have been applied, or at least asufficient number of clips have been applied, the button could beactuated again to close the jaws to allow the clip applier to be removedthrough the trocar. Such an arrangement enables the user of the clipapplier to close the jaws without releasing a loose clip into thepatient.

Further to the above, embodiments are envisioned where a clip appliercomprises a motor and a motor controller. The motor controller can beconfigured to control the motor via a processor and a memory. The motorcontroller can implement motor control algorithms to configure the jawsto open and close as well as advance a clip into the jaws. For example,a motor control algorithm can be implemented to allow the jaws toadvance a clip into a crimping and/or forming position, as describedabove, after the jaws have been inserted through the trocar. By notfeeding a clip into the jaws until after the clip applier has beenintroduced into the patient, the jaws can be moved into a very compactarrangement when being inserted through the trocar as discussed above.

Turning now to FIG. 357, a graph 71100 depicts the movements of a cammember and a feeder shoe of a clip applier comprising a rotating clipmagazine (i.e., a barrel magazine), such as the clip applier 70600, forexample. The operation of the clip applier depicted in FIG. 357 issimilar to that of clip applier 70600 in many respects. For example, thecam member is similar to closure tube 70620, the feeder shoe is similarto feeder member 70630, and the barrel magazine is similar to rotatableclip magazine 70650 illustrated in FIGS. 335-344, for example. The clipapplier is placed into the patient through a trocar with the jaws closedand a clip positioned in the jaws and another clip aligned with thefeeder shoe for deployment out of the barrel magazine. With the feedershoe in the home position (i.e., zero displacement) the cam member canbe advanced to a fully advanced position from the home position to crimpthe clip already placed within the jaws. In at least one instance, thedistance between the home position and the fully advanced position is0.3″, for example. The cam member is then retracted to a partiallyadvanced position just proximal to the fully advanced position to reducethe force applied to the clip by the jaws. The cam member is advancedagain to the fully advanced position to crimp the clip again. Byapplying a force, reducing that force, and then applying the same, oranother, force again, the elasticity within the clip can be reduced suchthat full plastic deformation can occur to properly crimp the clip ontothe patient tissue. The partially advanced position is dependent on thetype of clip being utilized with the clip applier. For example, thepartially advanced position is preferably 0.2″ distal from the homeposition for a clip with a clip opening of 0.210″ and is preferably0.23″ distal from the home position for a clip with a clip opening of0.180″, for example. Suitable thresholds can be set by the userdepending on the type of clips in the barrel magazine being utilizedwith the clip applier. Other embodiments are envisioned with differentclip sizes and position arrangements for the partially retracted andfully advanced positions.

In any event, after the clip has been properly crimped, the cam memberis then retracted proximally toward the home position as the feeder shoedistally advances a clip out of the barrel magazine toward the jaws ofthe clip applier into a pre-form position when the feeder shoe is 0.08″distal from the home position, for example. When the clip is in thepre-form position, the jaws can be partially opened by retracting thecam member slightly beyond the home position, i.e., the cam memberinteracts with the jaws of the clip applier to open the jaws when thecam member is retracted proximal to the home position, as discussedabove. Such an arrangement allows the clip to be expanded by thepre-form features on each of the jaws (i.e., protrusions 70608) asdiscussed above. The feeder shoe then distally advances the clip furtherinto a crimping position—0.3″ distal to the home position, for example.Once the feeder shoe is advanced beyond the barrel magazine (i.e., tothe pre-form position) the barrel magazine can be cycled (i.e., rotated)to position another clip for advancement into the jaws. The barrelmagazine is cycled by retracting the cam member to a fully retractedposition—0.05″ proximal to the home position, for example. The cycledclip will be biased against the feeder shoe which prevents the clip frombeing completely ejected from the barrel magazine. Once the feeder shoeis retracted to the home position the cycled clip can be displayed(i.e., the biasing member in the barrel magazine can now position thecycled clip into alignment with the feeder shoe because the feeder shoehas been retracted and is no longer blocking such movement). At thispoint a clip that has been pre-formed is positioned in the jaws andanother clip is aligned with the feeder shoe for deployment out of thebarrel magazine into the clip applier jaws, just as when the clipapplier was first inserted into the patient. The same operationsdiscussed above can be performed until all of the clips in the barrelmagazine are spent.

A graph 71200 of a firing member of a clip applier, such as any of theclip appliers described herein, for example, is illustrated in FIG. 358.The graph 71200 shows the relationship between the force required toadvance a clip within the clip applier (i.e., via the firing member)versus displacement. With further reference to FIG. 358, a graph 71300of the same clip applier is illustrated showing the relationship betweenthe voltage applied to the motor driving the firing member of the clipapplier versus time. The motor controller of the clip applier canmonitor the current being drawn by the motor and/or the force beingapplied to the firing member by the motor to detect a clip feed jam, oran irregular force within the clip applier, and then prevent furtheradvancement of the firing member by implementing changes to the voltageapplied to electric motor, as seen in graph 71300. In other words, ifthe monitored force exceeds a threshold value, and/or the monitoredmotor current exceeds a threshold value, during the clip feed step, themotor controller can, one, reduce the magnitude of the voltage potentialbeing applied to the motor for a period of time and, two, further assessthe force within the firing system and/or further assess the electricalcurrent being drawn by the motor. If the force and/or motor currentcontinue to increase with the continued application of voltage to themotor, the motor control system can stop the motor and/or reverse thedirection of the motor shaft to retract the firing member through ashort stroke distance to clear the jammed clip. Once the jammed clip iscleared, the clip applier can return to its normal operation and preparethe next clip to be advanced in accord with the normal operatingsequence of the clip applier.

Other embodiments are envisioned where clearing the jammed clip isaccomplished by interrupting the normal sequence of the end effector jawoperations. More specifically, once the clip jam is detected the controlsystem of the clip applier (i.e., motor controller, processor, andmemory) could request the clinician initiate a jam removal actuation.The jam removal actuation results in the jaws of the clip applier beingopened further than normal prior to another attempt to re-advance theclip. During the attempt to re-advance the clip, the acceptable loadthreshold, i.e., the current threshold and/or the force threshold, couldbe elevated above the normal thresholds previously discussed to insurethe clip is ejected from the jaws. Once the jammed clip has beenejected, the clip applier could return to its normal operation andprepare the next clip to be advanced in accord with the normal operatingsequence of the clip applier.

As mentioned above, certain clip appliers can be loaded with clipshaving a first size and/or a second size. The relative size of the clipscan be measured using any suitable dimension, such as the leg-to-legwidth of the clips, for example. First clips having a first width can bewider than second clips having a second width. In various instances, theclip applier can be loaded with only first clips, only second clips, orboth first and second clips at the same time. In any event, clips havingdifferent sizes may deform differently for a given closure stroke of theclip jaws. Thus, for instance, a first closure stroke of the clip jawsmay be more preferable for the first clips while a second closure strokeof the clip jaws may be more preferable for the second clips. Many ofthe clip appliers disclosed herein are capable of selectively applyingmore than one closure stroke to the clip jaws; however, in order toapply the correct closure stroke to a clip, the clip applier needs to beable to assess which size of clip is positioned within the clip jaws. Incertain instances, such information can be manually entered into thecontrol system of the clip applier by the clinician. Such an arrangementis convenient when the clips in the clip applier all have the same size.In various instances, the clip cartridge attached to the clip appliercomprises a marker, such as a microchip, for example, which can beevaluated by the control system and/or a sensor circuit in communicationwith the control system, for example. Such an arrangement is convenientwhen the clips in the clip cartridge all have the same size.

In various instances, further to the above, the clip applier can beconfigured to assess the clip positioned between the clip jaws of theclip applier to assess the size of the clip. Once a clip is loadedbetween the clip jaws, the control system can partially operate the jawclosure drive and observe the force within the jaw closure drive and/orthe current drawn by the electric motor of the jaw closure drive. Thecontrol system is configured to compare the measured data to data storedin a memory device, for example, to assess whether the clip between theclip jaws is a first clip or a second clip, or any other clip. Forinstance, if the measured force and/or motor current follows a firstprofile, then the control system will determine that the clip is a firstclip and then apply the first closure stroke. Similarly, the controlsystem will apply the second closure stroke if the measured force and/ormotor current follows a second profile for the second clip. As such, thecontrol system can use the jaw closure drive to apply a short evaluationclosure stroke to assess the clip size and then complete the fullclosure stroke as appropriate. In at least one instance, the controlsystem can reset the jaw closure drive after performing the shortevaluation closure stroke and then complete a full closure stroke asappropriate. In various instances, it is envisioned that the shortevaluation closure stroke does not plastically deform, or at leastsubstantially plastically deform, the clip.

Referring to FIG. 359, a graph 71400 of the force applied to a pair ofjaws of a clip applier versus time is illustrated. The control system ofthe clip applier can monitor the force within the crimping drive and/orthe electric current drawn by the motor to determine the amount of forceneeded to crimp a clip positioned within the jaws of the clip applier.This feedback force is initially dependent on the size and/or type ofclip that is within the jaws for a first portion of the closure strokeof the jaws. Once the size/type of clip is determined, the force appliedto the jaws of the clip applier can be adjusted for the remainder of thejaw closure stroke to crimp the clip with the proper amount of force.Such an arrangement is convenient when more than one size of clip hasbeen loaded into the clip applier. Other embodiments are envisionedwhere an adaptive control program change is initiated by the cartridgeidentifying itself to the clip applier upon insertion into the clipapplier. This allows the clip applier to update to the alternativecontrol program and thresholds (i.e., the forces applied to the jaws)for the size/type of clip loaded into the clip applier. Further, analternative to the identification of the cartridge could be thedetection of the loads needed to accomplish the first job of the clipapplier, which could be the advancement of a clip from the cartridge orpre-forming a clip within the jaws as discussed above. The first job ofthe clip applier may have a significantly higher load threshold neededto complete the operation and exceeding that threshold, or not, willthen determine the subsequent operations the clip applier and thethreshold limits of each operation.

Many of the clip appliers discussed herein have been discussed in thecontext that the clip jaws of the clip appliers are squeezed to crush aclip into its proper size. Other embodiments are envisioned in which aclip is elastically or resiliently stretched and then released once thetargeted tissue has been positioned within the stretched clip. Such anarrangement can be particularly useful when clamping or clipping bloodvessels, for example. In such instances, a clip can be released toresiliently return to, or at least toward, its unstretched position andclamp the blood vessel in an atraumatic, or a nearly atraumatic, manner.All of the clip appliers disclosed herein can be adapted to apply suchstretch-and-release clips. Moreover, further to the above, the clipappliers disclosed herein can be configured to apply both theclamp-to-crush clips and the stretch-and-release clips. Similar to theabove, the clip appliers would need to be able to identify the type ofclips contained therein in order to apply them properly to the patienttissue. Identification chips in the clip cartridges could be used forsuch purposes, for example.

FIG. 362 depicts a clip applier system 71500 in accordance with at leastone embodiment. The clip applier system 71500 comprises the clip applier70600 discussed above. The clip applier system 71500 further comprises amagnet aligned with one of the clips 70654 of the rotatable clipmagazine 70650. The clip applier system 71500 further comprises asensor, such as a Hall Effect sensor 71502, for example, fixedlypositioned within the ground portion 70612 of the clip applier 70600.The magnet can be sensed by the Hall Effect sensor 71502 and, based onthe voltage potential created by the Hall Effect sensor, the controlsystem of the clip applier 71500 can determine the radial location andorientation of the magnet and, thus, the radial location and orientationof the clip magazine 70650. When the magnet is in a first position71504, referring to FIG. 363, the rotatable clip magazine 70650 isloaded with a full compliment of clips 70654 and one of the clips 70654can be advanced out of the rotatable clip magazine 70650 into the endeffector 70605. The rotatable clip magazine 70650 can then be cycled(e.g., rotated) as discussed above, causing the magnet to move betweenthe first position 71504 and a second position 71506. Another clip 70654can be advanced out of the rotatable clip magazine 70650 and therotatable clip magazine 70650 can be cycled again, causing the magnet tomove to a third position 71508. Another clip 70654 can be advanced outof the rotatable clip magazine 70650 and the rotatable clip magazine70650 can be cycled again, causing the magnet to move to a fourthposition 71510. Further, another clip 70654 can be advanced out of therotatable clip magazine 70650 and the rotatable clip magazine 70650 canbe cycled again, causing the magnet to move to a fifth position 71512.In the fifth position 71512, the last clip 70654 in the rotatable clipmagazine 70650 can be advanced out of the rotatable clip magazine 70650.Thus, the clip applier system 71500 can determine the status of the clipmagazine 70650 (i.e., the number of clips remaining) depending on theposition of the magnet relative to the Hall Effect sensor 71502. Furtherto the above, FIG. 363 depicts the voltage potential generated by theHall Effect sensor 71502 depending on the position of the magnet.

In at least one alternative embodiment of the clip applier system 71500,the clip magazine 70650 further comprises an extension member, or bar,that extends proximally from the clip magazine 70650 once all of theclips 70654 have been ejected from the clip magazine 70650. Theextension member is sensed by the Hall Effect sensor 71502 and/oranother electrical sensor within the clip applier 70600. When theextension member is detected by the clip applier system 71500, themechanical systems (i.e., the feeder member 70630, firing member 70640,and drive tube 70620) of the clip applier 70600 can be locked out toprevent further actuation.

FIG. 364 depicts a clip applier 71600. The clip applier 71600 comprisesa first jaw 71610 a and a second jaw 71610 b moveable relative to eachother between open and closed positions. The clip applier 71600 isconfigured to receive a clip 71604 which is crimped by the first jaw71610 a and the second jaw 71610 b when the first jaw 71610 a and thesecond jaw 71610 b are moved toward the closed position. The clipapplier 71600 comprises a resistive sensing circuit configured todetermine the position of the clip 71604 within the clip applier 71600.The resistive sensing circuit comprises a supply voltage source 71602which supplies current through a first lead 71620 a, the first jaw 71610a, the clip 71604, the second jaw 71610 b, and a Resistor 71620 b andback to a return 71606 where the current can be measured. When the clip71604 is moved distally though the clip applier, such as to the positionshown by clip 71604′, for example, the path through which the currentflows is larger (i.e., larger than the path for clip 71604) and theresistance within the path is greater and, as a result, the currentmeasured at the return 71606 will be smaller. Thus, the current measuredat the return 71606 is directly proportional to the position of the clip71604 within the clip applier 71600. The control system of the clipapplier is configured to use the magnitude of the current in thissensing circuit to assess the position of the clip 71604′ within thejaws 71610 a and 71610 b. Higher current magnitudes indicate that theclip 71604′ is more proximal and lower current magnitudes indicate thatthe clip 71604's is more distal, while intermediate current magnitudesindicate that the clip 71604′ is positioned in the middle of the jaws71610 a and 71610 b.

Referring still to FIG. 364, the clip applier 71600 further comprises asecond resistive sensing circuit configured to determine when the firstjaw 71610 a and the second jaw 71610 b are in the closed position. Morespecifically, the supply voltage supplies current which flows through afirst lead 71630 a connected to the first jaw 71610 a. The first lead71630 a is insulated from the first jaw 71610 a, i.e., it does not allowcurrent to flow into the first jaw 71610 a. When the first jaw 71610 aand the second jaw 71610 b are in the closed position, the first lead71630 a contacts a second lead 71630 b connected to the second jaw 71610b which allows current to flow into a resistor 71630 c and into thereturn 71606 where the current can be measured. The second lead 71630 bis also insulated from the second jaw 71610 b. Thus, when the first jaw71610 a and the second jaw 71610 b are in the closed position, thecontrol system, via the return, will sense a current determined by asecond resistance through the resistor 71630 c which indicates that thefirst and second jaws 71610 a, 71610 b are in the closed position. Thecontrol system may, at the same time, also sense the resistance throughresistor 71620 b which indicates the position of the clip 71604 withinthe clip applier 71600. Other embodiments are envisioned where only oneof the resistive sensing circuits discussed above are utilized with theclip applier 71600.

FIGS. 365 and 366 depict a variable resistance system for use with aclip applier 71650 configured to gather information (i.e., data) on theposition of the clip jaws and the formation of the clip during acrimping stroke. The clip applier 71650 is similar to clip applier71600, for example, in many respects. The clip applier 71650 comprises afirst jaw 71650 a and a second jaw 71650 b moveable relative to eachother between an open position (FIG. 365), a partially closed position(FIG. 366) and a closed position. The clip applier 71650 is configuredto receive a clip 71654 which is crimped by the first and second jaws71650 a, 71650 b when the first and second jaws 71650 a, 71650 b aremoved toward the closed position. The legs of the clip 71654 positionedwithin the first and second jaws 71650 a, 71650 b extend outwardly intoengagement with the first and second jaws 71650 a, 71650 b to ensure theclip 71654 is properly seated therebetween (i.e., so there is no slop orplay between the clip 71654 and the first and second jaws 71650 a, 71650b). In various instances, the legs of the clip are slightly deflectedinwardly when the clip is fed into the first and second jaws 71650 a,71650 b. The variable resistance system of the clip applier 71650 isdescribed in further detail below.

The variable resistance system comprises three return paths throughwhich an electrical current can flow and be sensed by the control systemof the clip applier in order to determine the position of the first andsecond jaws 71650 a, 71650 b relative to each other, and to sense theformation of the clip 71654. The first return path 71660 comprises thesecond jaw 71650 b. The second return path 71670 comprises a variableresistor configured to determine the position of the first jaw 71650 aand the second jaw 71650 b relative to each other. More specifically, asthe first jaw 71650 a and the second jaw 71650 b are moved from the openposition (FIG. 365) toward the closed position the resistance in thevariable resistor will change. The third return path 71680 comprisesanother variable resistor at the distal end of the second jaw 71650 bwhich is insulated from the second jaw 71650 b. When the first jaw 71650a and the second jaw 71650 b are in the open position (FIG. 365), theclip 71654 is in contact with the first return path 71660 and the thirdreturn path 71680. When the first jaw 71650 a and the second jaw 71650 nare in the partially closed position (FIG. 366), the clip 71654 is onlyin contact with the first return path 71660. When the first jaw 71650 aand the second jaw 71650 b are in the closed position the clip 71654 hasbeen fully crimped and is once again in contact with the first returnpath 71660 and the third path 71680. Throughout the movement of thefirst jaw 71650 a and the second jaw 71650 b between the open position,the partially closed position, and the closed position, the secondreturn path 71670 determines the position of the first jaw 71650 arelative to the second jaw 71650 b. Thus, the variable resistance systemcan determine jaw position and sense clip formation throughout the clipformation process by determining the resistance through each of thethree paths.

FIG. 367 depicts a clip applier jaw 71700 in accordance with at leastone embodiment. The clip applier jaw 71700 is configured to move towardand away from another clip applier jaw and is further configured tocrimp a clip as discussed above in relation to various embodimentsdisclosed herein. The clip applier comprises a proximal strain gauge71720 and a distal strain gauge 71730, and/or any number of suitablestrain gauges. The proximal strain gauge 71720 and the distal straingauge 71730 are positioned on a face 71710 of the clip applier jaw71700. Other embodiments are envisioned with more than two strain gaugesspaced along any suitable face of the clip applier jaw 71700 and/orbuilt into the clip applier jaw 71710 itself. The proximal strain gauge71720 is pan of a proximal strain gauge circuit and generates a voltagesignal indicative of the strain within the clip applier jaw 71700 in afirst location and the distal strain gauge 71730 is part of a distalstrain gauge circuit and generates a voltage signal indicative of thestrain within the clip applier jaw 71700 in a second location. Theproximal and distal strain gauge circuits are in communication with thecontrol system of the clip applier and, as a clip is formed between theclip applier jaw 71700 and another clip applier jaw, different levels ofstrain will be detected by the control system at the first location andthe second location.

Referring to FIG. 368, a graph 71800 of the strain (measured in Volts,but could be more conveniently illustrated in mV) within the proximalstrain gauge 71720 and the distal strain gauge 71730 at various stagesof clip formation is depicted. Upon the initial placement of a clipbetween the clip applier jaws, the clip legs of certain clips are biasedoutwardly into engagement with the jaws, as discussed above. In suchinstances, a larger strain may be measured in the proximal strain gauge71720 as compared to the distal strain gauge 71730. The difference inthe voltages within the strain gauges 71720, 71730 at this stage isvoltage A as depicted in FIG. 368. As the jaws of the clip applier beginto form the clip, the reading from the proximal strain gauge 71720 willexceed a pre-formed strain threshold T_(PF) while the reading from thedistal strain gauge 71730 remains below the pre-formed strain thresholdT_(PF). This can indicate that the clip has only been formed at or nearthe proximal strain gauge 71720. The difference in the voltages betweenthe readings of the strain gauges 71720, 71730, at this stage, ismeasured to be A′. As the jaws of the clip applier form the clipfurther, the reading from the distal strain gauge 71730 will eventuallyexceed the pre-formed strain threshold T_(PF) and the reading from theproximal strain gauge 71720 will eventually exceed a full-formed strainthreshold T_(FF). This can indicate that the clip has been fully formedat or near the proximal strain gauge 71720 and has begun to be deformedat or near the distal strain gauge 71730. When the readings from theproximal strain gauge 71720 and the distal strain gauge 71730 are bothmeasured to be beyond the full-formed threshold T_(FF) and thepre-formed threshold T_(PF), respectively, the difference in the straingauge readings is measured as A″ as depicted in FIG. 368. Further, asthe jaws of the clip applier form the clip further, the reading from thedistal strain gauge 71730 will eventually exceed the full-formed strainthreshold T_(FF) and the reading from the proximal strain gauge 71720will continue to increase above the full-formed strain threshold T_(FF).When the reading from the proximal strain gauge 71720 and the distalstrain gauge 71730 are measured to both be beyond the full-formedthreshold T_(FF), the difference in the strain gauge readings ismeasured as A′″ as depicted in FIG. 368.

Further to the above, the state of the clip can be determined bymeasuring the differences between the readings of the proximal straingauge 71720 and the distal strain gauge 71730 throughout the formationof a clip. More specifically, a difference in voltage measuring Aindicates that the clip has yet to be deformed. A difference in voltagemeasuring A′ indicates that only a proximal portion of the clip has beendeformed. A difference in voltage measuring A″ indicates that theproximal portion of the clip has been fully formed and the distalportion of the clip has begun to be deformed. And lastly, a differencein the voltage measuring A′″ indicates that both the proximal and distalportions of the clip have been fully formed.

As discussed above, a clip applier is often inserted into a patientthrough a trocar. As a result, the diameter of the passageway throughthe trocar dictates a lot of the design considerations of the clipapplier—especially of the portions of the clip applier that are insertedthrough and/or into the trocar passageway. That said, there is oftenmotivation to make trocars as narrow as possible to reduce the size ofthe incisions in the patient, among other reasons. As such, narrowtrocars, and narrow trocar passageways, present significant designconstraints and often limit the widths of the clips that can be used.With this in mind, clip appliers are disclosed herein which areconfigured to store the clips in a small configuration and then enlargethe clips once they are on the other side of the trocar. Such anarrangement can allow clips to be used which, in their enlarged state,exceed the diameter of the trocar that they were inserted through.

FIGS. 369 and 370 depict a clip applier 71900 in accordance with atleast one embodiment. The clip applier 71900 comprises a first jaw 71910a and a second jaw 71910 b moveable relative to each other about a pivotpin 71912 between a closed position, a home position (FIG. 369), and anopen position (FIG. 370). The clip applier 71900 further comprises a cammember 71920 configured to move the first jaw 71910 a and the second jaw71910 b between the closed position, the home position, and the openposition. More specifically, the first jaw 71910 a and the second jaw71910 b are moved to the open position by the cam member 71920 when thecam member 71920 is moved to a fully retracted position (FIG. 370) dueto the cam member 71920 engaging a first jaw cam 71914 a on the firstjaw 71910 a and a second jaw cam 71914 b on the second jaw 71910 b.Furthermore, the first jaw 71910 a and the second jaw 71910 b are movedto the home position by the cam member 71920 when the cam member 71920is moved distally to a home position depicted in FIG. 369 (i.e., the cammember 71920 is no longer engaging the first jaw cam 71914 a and thesecond jaw cam 71914 b allowing the first jaw 71910 a and the second jaw71910 b to assume the home position). Further still, the first jaw 71910a and the second jaw 71910 b are moved to the closed position by the cammember 71920 when the cam member 71920 is moved distally to a fullyadvanced position due to the cam member 71920 cammingly engaging theouter surfaces of the first jaw 71910 a and the second jaw 71910 b. Thefirst jaw 71910 a and the second jaw 71910 b are configured to receive aclip 71904 therein to be expanded during a pre-form operation andcrimped during a crimping operation. FIG. 369 depicts the clip 71904 ina storage configuration when the first jaw 71910 a and the second jaw71910 b are in the home position. The clip 71904 can be a 5 mm clip inthe storage configuration, for example. Expansion of the clip 71904during the pre-form operation and crimping of the clip 71904 during thecrimping operation are described in further detail below.

The first jaw 71910 a and the second jaw 71910 b comprise pre-formingfeatures, or protrusions 71930 a and 71930 b, similar to protrusions70126 a and 70126 b discussed above. The protrusions 71930 a and 71930 bengage the inner surfaces of the clip 71904 and expand the clip 71904from the storage configuration (FIG. 369) to a firing configuration(FIG. 370) when the first jaw 71910 a and the second jaw 71910 b aremoved to the open position. For example, the clip 71904 is expanded fromthe storage configuration where the clip 71904 has an approximately 5 mmwidth to a firing configuration where the clip 71904 has anapproximately 10 mm width. That said, a clip can have any suitablestored width and any suitable expanded width. After the clip 71904 hasbeen expanded to the firing configuration, a firing member advances theclip over the protrusions 71930 a, 71930 b into a crimping positionwithin the first jaw 71910 a and the second jaw 71910 b. The protrusions71930 a and 71930 b comprise angled portions which allow the clip 71904to slide over the protrusions 71930 a and 71930 b when advanced by thefiring member. Once a clip is in the crimping position, the cam member71920 is advanced distally to the fully advanced position during acrimping stroke to move the first jaw 71910 a and the second jaw 71910 bto the closed position, and, thus, crimp the clip 71904 within thecrimping chamber.

Further to the above, the clip applier 71900 further comprises a sensorarray 71940 that detects a magnet 71950 included in one of the first jaw71910 a and the second jaw 71910 b. The sensor array 71940 detects thelocation of the magnet 71950 relative to the sensor array 71940 in orderto determine the position of the first jaw 71910 a and the second jaw71910 b relative to each other during the operation of the clip applier71900.

As discussed herein, clip appliers are loaded with clips in a variety ofmanners. For instance, clips can be loaded into a clip applier by way ofa clip cartridge. Such clip cartridges can comprise clips stacked alonga longitudinal axis, for example. Such clip cartridges can also compriseclips stacked along an axis which is transverse to the longitudinal axisof the clip applier. Certain cartridges are stored in a circumferentialconfiguration, as described above. That being said, some clip appliersmay be configured to hold only one clip at a time. The teachingsprovided herein are adaptable to such clip appliers. In at least oneinstance, a one-clip clip applier, for example, can be used with adocking station comprising a plurality of clips stored therein. In suchinstances, the clinician can use the docking station to re-supply a clipto the one-clip clip applier after each use of the clip applier. Incertain instances, the docking station can be positioned in the patientwhich prevents the need to remove the clip applier from the patient suchthat the clip applier can be reloaded. In at least one instance, asdiscussed below, the docking station can be attached to a trocarinserted into the patient, for example. The above being said, the ideaof a docking station positioned within a patient can also be used with amulti-clip clip applier. In such instances, one or more clips from thedocking station can be loaded into the multi-clip clip applier withouthaving to remove the clip applier from the patient.

Turning to FIGS. 371 and 372, a clip applier system 72000 is depicted.The clip applier system comprises a trocar 72010, a clip magazine 72050,and a clip applier 72020. The clip applier 72020 comprises an elongateshaft 72011 extending from a housing, an articulation joint 72022extending from the elongate shaft 72011, and an end effector 72024extending from the articulation joint 72022. The end effector 72024comprises a first jaw 72024 a and a second jaw 72024 b moveable relativeto each other between an open position and a closed position. The endeffector 72024 is articulable relative to the elongate shaft 72011 aboutthe articulation joint 72022. The clip magazine 72050 comprises anopening 72051 (see FIG. 371) through the clip magazine 72050. Prior toinsertion of the clip applier 72020 through the trocar 72010, the clipmagazine 72050 is positioned within the patient and attached to thedistal end of the trocar 72010. The opening 72051 allows the clipmagazine 72050 to be received and attached to the distal end of thetrocar 72010 as depicted in FIG. 372. The clip magazine 72050 can bethreadably attached to the distal end of the trocar 72010, for example.The clip applier 72020 is then inserted through the trocar 72010 and theopening 72051 of the clip magazine 72050 until the end effector 72024 ofthe clip applier 72020 is positioned distal to the clip magazine 72050.As the clip applier 72020 is retracted toward the clip magazine 72050,the clip applier 72020 engages the clip magazine 72050 to eject a clipfrom the clip magazine 72050 into the end effector of the clip applier72020, as discussed in greater detail below.

Turning to FIGS. 376 and 377, the clip magazine 72050 further comprises,a leaf spring 72052, a plurality of clips 72054 removably stored in theclip magazine 72050, a spring 72059, a sled 72058, and a loading arm72056. The leaf spring 72052 prevents the clips 72054 from falling outof the clip magazine 72050 inadvertently. The spring 72059 biases thesled 72058 distally to bias the clips 72054 toward the loading arm72056. The loading arm 72056 grasps and holds a clip 72054 in placeuntil acted upon by the clip applier 72020. To this end, the loading arm72056 engages a jaw wing 72026 of the clip applier 72020 as the clipapplier 72020 is retracted towards the clip magazine 72050 (i.e.,proximally). When the jaw wing 72026 is engaged by the loading arm72056, the jaw wing 72026 moves proximally and the loading arm 72056rotates toward the end effector 72024 to load a clip 72054 from the clipmagazine 72050 into the end effector 72024 of the clip applier 72020.FIGS. 373-375 depict the movements of the jaw wing 72024 and the loadingarm 72056 as the clip applier 72020 is retracted towards the clipmagazine 72050. After a clip 72054 has been loaded into the end effector72024, the clip applier 72024 can be moved distally to a desiredlocation within the patient to crimp the clip 72054 around patienttissue. After the clip 72054 is crimped and released, the clip applier72020 can be retracted toward the clip magazine 72050 (i.e., proximally)to engage the jaw wing 72026 with the loading arm 72056 of the clipmagazine 72050 to load another clip into the clip applier 72020. Thisprocess can be repeated until all of the clips 72054 have been depletedfrom the clip magazine 72050, and/or until a suitable number of clipshave been applied.

Turning now to FIGS. 378 and 379, the relationship between the jaw wing72026 and the first and second jaws 72024 a and 72024 b of the clipapplier 72020 is depicted. The jaw wing 72026 is operably engaged withthe first and second jaws 72024 a and 72024 b such that, when the firstand second jaws 72024 a and 72024 b are in the closed position (FIG.379), the jaw wing 72026 is retracted. To this end, the clip applier72020 can be inserted through the clip magazine 72050 without the jawwing 72026 engaging the loading arm 72056 of the clip magazine 72050.Other embodiments are envisioned where the clip applier 72020 engagesthe clip magazine 72050 to load a clip 72054 into the end effector 72024when the clip applier 72020 is moved from a proximal position behind theclip magazine 72050 to a distal position beyond the clip magazine 72050.

A clip applier 73000 is depicted in FIGS. 380-383. The clip applier73000 comprises an elongate shaft 73010 extending from a housing, anarticulation joint 73020 extending from the elongate shaft 73010, amagazine housing 73030 extending from the articulation joint 73020, andan end effector 73040 extending from the magazine housing 73030. The endeffector 73040 comprises a first jaw 73040 a and a second jaw 73040 bmoveable relative to each other between an open position and a closedposition. The magazine housing 73030 comprises a bottom housing 73030 band a top housing 73030 a. The top housing 73030 a is movable relativeto the bottom housing 73030 b between an open position (FIG. 380) and aclosed position (FIG. 382) about a pivot pin 73032 attached to thearticulation joint 73020. The magazine housing 73030 can receive a clipmagazine 73050 comprising a plurality of clips 73054 stored therein. Theclips 73054 are loaded into the clip magazine 73030 and are locked inplace by a biasing member, or leaf spring 73056. The leaf spring 73056prevents the clips 73054 from being ejected form the clip magazine 73050until the clip magazine 73050 is seated in the magazine housing 73030,as discussed in greater detail below.

The clip magazine 73050 further comprises notches 73058 on either sideof the clip magazine 73050. To properly seat the clip magazine 73050 inthe magazine housing 73030, the notches 73058 of the clip magazine 73050are aligned with protrusions 73034 of the magazine housing 73030 to seatand align the clip magazine 73050 in the magazine housing 73030 asdepicted in FIG. 381. Once the clip magazine 73050 is installed into themagazine housing 73030, the top housing 73030 a can be moved to theclosed position as depicted in FIG. 382. The top housing 73030 acomprises a lockout release, or protrusion 73032, that engages the leafspring 73056 of the clip magazine 73050 when the clip magazine 73050 isinstalled in the magazine housing 73030 and the top housing 73030 a isin the closed position as depicted in FIG. 383. When the leaf spring73056 is depressed by the protrusion 73032, the clips 73054 are nolonger locked into position within the clip magazine 73050 and can beejected from the clip magazine 73050 into the end effector 73040 by afiring member.

Turning now to FIGS. 384-387, after all of the clips 73054 have beenejected from the clip magazine 73050, the clip magazine 73050 can belocked out when removed from the magazine housing 73030 to prevent theclip magazine 73050 from being re-installed into the magazine housing73030 until reloaded with at least one new clip 73054. Morespecifically, the clip magazine 73030 comprises a sled 73052 that movesthrough the clip magazine 73030 as the clips 73054 are ejected. The sled73052 comprises spring loaded detents 73059 which align with the notches73058 in the clip magazine 73050 when the last clip 73054 has beenejected form the clip magazine 73050. When the clip magazine 73050 isinstalled in the magazine housing 73030 and the clip magazine 73050 hasbeen spent, the spring loaded detents 73059 are biased against theprotrusions 73034 as depicted in FIGS. 385 and 387. After the clipmagazine 73050 is removed from the magazine housing 73030, the springloaded detents 73059 protrude through the notches 73058 to lock the sled73052 into place as depicted in FIG. 384. The spent clip magazine 73050cannot be re-installed into the magazine housing 73030 unless at leastone clip 73054 is loaded into the clip magazine 73050. Morespecifically, until the sled 73052 is retracted to disengage the springloaded detents 73059 from the notches 73058 (i.e., at least one clip73054 is installed) the clip magazine 73050 cannot be installed into themagazine housing 73030 because the spring loaded detents 73059 occupythe notches 73058 and will not allow the notches 73058 to properly alignand seat with the protrusions 73034 of the magazine housing 73030.

Other embodiments are envisioned where a clip applier system comprises aclip applier, a trocar, and a sensing system. The clip applier of theclip applier system is similar to clip applier 72020 in many respectsand the trocar is similar to the trocar 72010 in many respects. Thetrocar can comprise a sensor, such as a Hall Effect sensor, for example,attached to, or near, the distal end of the trocar. The clip applierfurther comprises a detectable element, such as a magnet, for example,positioned in the end effector of the clip applier. The magnet in theend effector of the clip applier and the Hall Effect sensor on thedistal end of the trocar are included in the sensing system. The sensingsystem is in signal communication with the control system of the clipapplier via a wireless signal transmitter in the trocar and a wirelesssignal receiver in the clip applier. The control system of the clipapplier is configured to automatically control the opening and closingof the jaws of the end effector depending on the position of the magnetrelative to the Hall Effect sensor. More specifically, when the magnetin the jaws is positioned a predetermined distance distal to the HallEffect sensor of the trocar—which indicates that the jaws have passedthrough the trocar, the clip jaws are automatically moved to an openposition by the control system of the clip applier. Moreover, thecontrol system of the clip applier can also automatically load a clipinto the open jaws. Such an arrangement reduces the time needed to loadthe clip applier after being inserted into a patient. Further, when themagnet in the jaws is approaching the Hall Effect sensor of the trocarfrom a distal position (i.e., the clip applier is being retractedproximally toward the trocar) the control system automatically moves thejaws to a closed position to allow the clip applier to be retractedthrough the trocar.

FIG. 388 is a logic diagram of a control system 75000 for use with anyof the various clip appliers described herein. The control system 75000comprises a control circuit. The control circuit includes amicrocontroller 75040 comprising a processor 75020 and a memory 75030.One or more sensors, such as sensor 75080, sensor 75090, sensor 71502,and sensor array 71940, for example, provide real time feedback to theprocessor 75020. The control system 75000 further comprises a motordriver 75050 configured to control an electric motor 75010 and atracking system 75060 configured to determine the position of one ormore longitudinally movable components in the clip applier, such asfiring member 70165 (FIG. 309), crimping drive 70180 (FIG. 312), feedermember 70630 (FIG. 336), firing member 70640 (FIG. 336), and closuretube 70620 (FIG. 336), for example. The tracking system 75060 is alsoconfigured to determine the position of one or more rotationalcomponents in the clip applier, such as the rotatable clip magazine70650 (FIG. 335), for example. The tracking system 75060 providesposition information to the processor 75020, which can be programmed orconfigured to, among other things, determine the position of therotatable clip magazine 70650 (FIG. 335), determine the position of thefiring member, feeder member, closure tube and/or crimping drive, aswell as determine the orientation of the jaws of the clip applier. Themotor driver 75050 may be an A3941 available from Allegro Microsystems,Inc., for example; however, other motor drivers may be readilysubstituted for use in the tracking system 75060. A detailed descriptionof an absolute positioning system is described in U.S. PatentApplication Publication No. 2017/0296213, entitled SYSTEMS AND METHODSFOR CONTROLLING A SURGICAL STAPLING AND CUTTING INSTRUMENT, the entiredisclosure of which is hereby incorporated herein by reference.

The microcontroller 75040 may be any single core or multicore processorsuch as those known under the trade name ARM Cortex by TexasInstruments, for example. In at least one instance, the microcontroller75040 is a LM4F230H5QR ARM Cortex-M4F Processor Core, available fromTexas Instruments, for example, comprising on-chip memory of 256 KBsingle-cycle flash memory, or other non-volatile memory, up to 40 MHz, aprefetch buffer to improve performance above 40 MHz, a 32 KBsingle-cycle serial random access memory (SRAM), internal read-onlymemory (ROM) loaded with StellarisWare® software, 2 KB electricallyerasable programmable read-only memory (EEPROM), one or more pulse widthmodulation (PWM) modules and/or frequency modulation (FM) modules, oneor more quadrature encoder inputs (QEI) analog, one or more 12-bitAnalog-to-Digital Converters (ADC) with 12 analog input channels, forexample, details of which are available from the product datasheet.

In various instances, the microcontroller 75040 comprises a safetycontroller comprising two controller-based families such as TMS570 andRM4x known under the trade name Hercules ARM Cortex R4, also by TexasInstruments. The safety controller may be configured specifically forIEC 61508 and ISO 26262 safety critical applications, among others, toprovide advanced integrated safety features while delivering scalableperformance, connectivity, and memory options.

The microcontroller 75040 is programmed to perform various functionssuch as precisely controlling the speed and/or position of the firingmember, feeder member, crimping drive or closure tube of any of the clipappliers disclosed herein, for example. The microcontroller 75040 isalso programmed to precisely control the rotational speed and positionof the end effector of the clip applier and the articulation speed andposition of the end effector of the clip applier. In various instances,the microcontroller 75040 computes a response in the software of themicrocontroller 75040. The computed response is compared to a measuredresponse of the actual system to obtain an “observed” response, which isused for actual feedback decisions. The observed response is afavorable, tuned, value that balances the smooth, continuous nature ofthe simulated response with the measured response, which can detectoutside influences on the system.

The motor 75010 is controlled by the motor driver 75050. In variousforms, the motor 75010 is a DC brushed driving motor having a maximumrotational speed of approximately 25,000 RPM, for example. In otherarrangements, the motor 75010 includes a brushless motor, a cordlessmotor, a synchronous motor, a stepper motor, or any other suitableelectric motor. The motor driver 75050 may comprise an H-bridge drivercomprising field-effect transistors (FETs), for example. The motordriver 75050 may be an A3941 available from Allegro Microsystems, Inc.,for example. The A3941 motor driver 75050 is a full-bridge controllerfor use with external N-channel power metal oxide semiconductor fieldeffect transistors (MOSFETs) specifically designed for inductive loads,such as brush DC motors. In various instances, the motor driver 75050comprises a unique charge pump regulator provides full (>10 V) gatedrive for battery voltages down to 7 V and allows the A3941 motor driver75050 to operate with a reduced gate drive, down to 5.5 V. A bootstrapcapacitor may be employed to provide the above-battery supply voltagerequired for N-channel MOSFETs. An internal charge pump for thehigh-side drive allows DC (100% duty cycle) operation. The full bridgecan be driven in fast or slow decay modes using diode or synchronousrectification. In the slow decay mode, current recirculation can bethrough the high-side or the lowside FETs. The power FETs are protectedfrom shoot-through by resistor adjustable dead time. Integrateddiagnostics provide indication of undervoltage, overtemperature, andpower bridge faults, and can be configured to protect the power MOSFETsunder most short circuit conditions. Other motor drivers may be readilysubstituted.

The tracking system 75060 comprises a controlled motor drive circuitarrangement comprising one or more position sensors, such as the sensor75080, sensor 75090, sensor 71502, and sensory array 71940, for example.The position sensors for an absolute positioning system provide a uniqueposition signal corresponding to the location of a displacement member.As used herein, the term displacement member is used generically torefer to any movable member of any of the clip appliers disclosedherein. In various instances, the displacement member may be coupled toany position sensor suitable for measuring linear displacement orrotational displacement. Linear displacement sensors may include contactor non-contact displacement sensors. The displacement sensors maycomprise linear variable differential transformers (LVDT), differentialvariable reluctance transducers (DVRT), a slide potentiometer, amagnetic sensing system comprising a movable magnet and a series oflinearly arranged Hall Effect sensors similar to the arrangementillustrated in FIG. 362, a magnetic sensing system comprising a fixedmagnet and a series of movable linearly arranged Hall Effect sensorssimilar to the arrangement illustrated in FIGS. 369 and 370, an opticalsensing system comprising a movable light source and a series oflinearly arranged photo diodes or photo detectors, or an optical sensingsystem comprising a fixed light source and a series of movable linearlyarranged photo diodes or photo detectors, or any combination thereof.

The position sensors 75080, 75090, 71502, and 71940 for example, maycomprise any number of magnetic sensing elements, such as, for example,magnetic sensors classified according to whether they measure the totalmagnetic field or the vector components of the magnetic field. Thetechniques used to produce both types of magnetic sensors encompass manyaspects of physics and electronics. The technologies used for magneticfield sensing include search coil, fluxgate, optically pumped, nuclearprecession, SQUID, Hall-Effect, anisotropic magnetoresistance, giantmagnetoresistance, magnetic tunnel junctions, giant magnetoimpedance,magnetostrictive/piezoelectric composites, magnetodiode,magnetotransistor, fiber optic, magnetooptic, and microelectromechanicalsystems-based magnetic sensors, among others.

In various instances, one or more of the position sensors of thetracking system 75060 comprise a magnetic rotary absolute positioningsystem. Such position sensors may be implemented as an AS5055EQFTsingle-chip magnetic rotary position sensor available from AustriaMicrosystems, AG and can be interfaced with the controller 75040 toprovide an absolute positioning system. In certain instances, a positionsensor comprises a low-voltage and low-power component and includes fourHall-Effect elements in an area of the position sensor that is locatedadjacent a magnet. A high resolution ADC and a smart power managementcontroller are also provided on the chip. A CORDIC processor (forCoordinate Rotation Digital Computer), also known as the digit-by-digitmethod and Volder's algorithm, is provided to implement a simple andefficient algorithm to calculate hyperbolic and trigonometric functionsthat require only addition, subtraction, bitshift, and table lookupoperations. The angle position, alarm bits, and magnetic fieldinformation are transmitted over a standard serial communicationinterface such as an SPI interface to the controller 75040. The positionsensors can provide 12 or 14 bits of resolution, for example. Theposition sensors can be an AS5055 chip provided in a small QFN 16-pin4×4×0.85 mm package, for example.

The tracking system 75060 may comprise and/or be programmed to implementa feedback controller, such as a PID, state feedback, and adaptivecontroller. A power source converts the signal from the feedbackcontroller into a physical input to the system, in this case voltage.Other examples include pulse width modulation (PWM) and/or frequencymodulation (FM) of the voltage, current, and force. Other sensor(s) maybe provided to measure physical parameters of the physical system inaddition to position. In various instances, the other sensor(s) caninclude sensor arrangements such as those described in U.S. Pat. No.9,345,481, entitled STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM,which is hereby incorporated herein by reference in its entirety; U.S.Patent Application Publication No. 2014/0263552, entitled STAPLECARTRIDGE TISSUE THICKNESS SENSOR SYSTEM, which is hereby incorporatedherein by reference in its entirety; and U.S. patent application Ser.No. 15/628,175, entitled TECHNIQUES FOR ADAPTIVE CONTROL OF MOTORVELOCITY OF A SURGICAL STAPLING AND CUTTING INSTRUMENT, which is herebyincorporated herein by reference in its entirety. In a digital signalprocessing system, absolute positioning system is coupled to a digitaldata acquisition system where the output of the absolute positioningsystem will have finite resolution and sampling frequency. The absolutepositioning system may comprise a compare and combine circuit to combinea computed response with a measured response using algorithms such asweighted average and theoretical control loop that drives the computedresponse towards the measured response. The computed response of thephysical system takes into account properties like mass, inertial,viscous friction, inductance resistance, etc., to predict what thestates and outputs of the physical system will be by knowing the input.

The absolute positioning system provides an absolute position of thedisplacement member upon power up of the instrument without retractingor advancing the displacement member to a reset (zero or home) positionas may be required with conventional rotary encoders that merely countthe number of steps forwards or backwards that the motor 75010 has takento infer the position of a device actuator, a firing member, a feederdrive, a crimping drive, a closure tube, and the like.

A sensor 75080 comprising a strain gauge or a micro-strain gauge, forexample, is configured to measure one or more parameters of the endeffector of the clip applier, such as, for example, the strainexperienced by the jaws during a crimping operation. In one embodiment,the sensor 75080 can comprise the strain gauges 71720 and 71730 (FIG.367) discussed in greater detail above, for example. The measured strainis converted to a digital signal and provided to the processor 75020. Inaddition to or in lieu of the sensor 75080, a sensor 75090 comprising aload sensor, for example, can measure the closure force applied by theclosure drive system to the jaws of the clip applier. In variousinstances, a current sensor 75070 can be employed to measure the currentdrawn by the motor 75010. The force required to clamp the first andsecond jaws to crimp a clip can correspond to the current drawn by themotor 75010, for example. The measured force is converted to a digitalsignal and provided to the processor 75020. A magnetic field sensor canbe employed to measure the thickness of the captured tissue. Themeasurement of the magnetic field sensor can also be converted to adigital signal and provided to the processor 75020.

The measurements of the tissue compression, the tissue thickness, and/orthe force required to close the end effector and crimp a clip aroundtissue as measured by the sensors can be used by the controller 75040 tocharacterize the position and/or speed of the movable member beingtracked. In at least one instance, the memory 75030 may store atechnique, an equation, and/or a look-up table which can be employed bythe controller 75040 in the assessment. In various instances, thecontroller 75040 can provide the user of the clip applier with a choiceas to the manner in which the clip applier should be operated. To thisend, a display 75044 can display a variety of operating conditions ofthe clip applier and can include touch screen functionality for datainput. Moreover, information displayed on the display 75044 may beoverlaid with images acquired via the imaging modules of one or moreendoscopes and/or one or more additional surgical instruments usedduring the surgical procedure.

As discussed above, the clip appliers disclosed herein may comprisecontrol systems. Each of the control systems can comprise a circuitboard having one or more processors and/or memory devices. Among otherthings, the control systems are configured to store sensor data, forexample. They are also configured to store data which identifies thetype of clip applier attached to a handle or housing, such as handle 700(FIG. 303), for example. More specifically, the type of clip applier canbe identified when attached to the handle or housing by the sensors andthe sensor data can be stored in the control system. Moreover, they arealso configured to store data including whether or not the clip applierhas been previously used and/or how many clips have been ejected fromthe clip magazine or clip cartridge of the clip applier duringoperation. This information can be obtained by the control system toassess whether or not the clip applier is suitable for use and/or hasbeen used less than a predetermined number of times, for example.

The surgical instrument systems described herein are motivated by anelectric motor; however, the surgical instrument systems describedherein can be motivated in any suitable manner. In certain instances,the motors disclosed herein may comprise a portion or portions of arobotically controlled system. U.S. patent application Ser. No.13/118,241, entitled SURGICAL STAPLING INSTRUMENTS WITH ROTATABLE STAPLEDEPLOYMENT ARRANGEMENTS, now U.S. Pat. No. 9,072,535, for example,discloses several examples of a robotic surgical instrument system ingreater detail, the entire disclosure of which is incorporated byreference herein.

The surgical instrument systems described herein can be used inconnection with the deployment and deformation of staples. Variousembodiments are envisioned which deploy fasteners other than staples,such as clamps or tacks, for example. Moreover, various embodiments areenvisioned which utilize any suitable means for sealing tissue. Forinstance, an end effector in accordance with various embodiments cancomprise electrodes configured to heat and seal the tissue. Also, forinstance, an end effector in accordance with certain embodiments canapply vibrational energy to seal the tissue. In addition, variousembodiments are envisioned which utilize a suitable cutting means to cutthe tissue.

The entire disclosures of:

U.S. patent application Ser. No. 11/013,924, entitled TROCAR SEALASSEMBLY, now U.S. Pat. No. 7,371,227;

U.S. patent application Ser. No. 11/162,991, entitled ELECTROACTIVEPOLYMER-BASED ARTICULATION MECHANISM FOR GRASPER, now U.S. Pat. No.7,862,579;

U.S. patent application Ser. No. 12/364,256, entitled SURGICALDISSECTOR, now U.S. Patent Application Publication No. 2010/0198248;

U.S. patent application Ser. No. 13/536,386, entitled EMPTY CLIPCARTRIDGE LOCKOUT, now U.S. Pat. No. 9,282,974;

U.S. patent application Ser. No. 13/832,786, entitled CIRCULAR NEEDLEAPPLIER WITH OFFSET NEEDLE AND CARRIER TRACKS, now U.S. Pat. No.9,398,905;

U.S. patent application Ser. No. 12/592,174, entitled APPARATUS ANDMETHOD FOR MINIMALLY INVASIVE SUTURING, now U.S. Pat. No. 8,123,764;

U.S. patent application Ser. No. 12/482,049, entitled ENDOSCOPICSTITCHING DEVICES, now U.S. Pat. No. 8,628,545;

U.S. patent application Ser. No. 13/118,241, entitled SURGICAL STAPLINGINSTRUMENTS WITH ROTATABLE STAPLE DEPLOYMENT ARRANGEMENTS, now U.S. Pat.No. 9,072,535;

U.S. patent application Ser. No. 11/343,803, entitled SURGICALINSTRUMENT HAVING RECORDING CAPABILITIES, now U.S. Pat. No. 7,845,537;

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Although various devices have been described herein in connection withcertain embodiments, modifications and variations to those embodimentsmay be implemented. Particular features, structures, or characteristicsmay be combined in any suitable manner in one or more embodiments. Thus,the particular features, structures, or characteristics illustrated ordescribed in connection with one embodiment may be combined in whole orin part, with the features, structures or characteristics of one oremore other embodiments without limitation. Also, where materials aredisclosed for certain components, other materials may be used.Furthermore, according to various embodiments, a single component may bereplaced by multiple components, and multiple components may be replacedby a single component, to perform a given function or functions. Theforegoing description and following claims are intended to cover allsuch modification and variations.

The devices disclosed herein can be designed to be disposed of after asingle use, or they can be designed to be used multiple times. In eithercase, however, a device can be reconditioned for reuse after at leastone use. Reconditioning can include any combination of the stepsincluding, but not limited to, the disassembly of the device, followedby cleaning or replacement of particular pieces of the device, andsubsequent reassembly of the device. In particular, a reconditioningfacility and/or surgical team can disassemble a device and, aftercleaning and/or replacing particular parts of the device, the device canbe reassembled for subsequent use. Those skilled in the art willappreciate that reconditioning of a device can utilize a variety oftechniques for disassembly, cleaning/replacement, and reassembly. Use ofsuch techniques, and the resulting reconditioned device, are all withinthe scope of the present application.

The devices disclosed herein may be processed before surgery. First, anew or used instrument may be obtained and, when necessary, cleaned. Theinstrument may then be sterilized. In one sterilization technique, theinstrument is placed in a closed and sealed container, such as a plasticor TYVEK bag. The container and instrument may then be placed in a fieldof radiation that can penetrate the container, such as gamma radiation,x-rays, and/or high-energy electrons. The radiation may kill bacteria onthe instrument and in the container. The sterilized instrument may thenbe stored in the sterile container. The sealed container may keep theinstrument sterile until it is opened in a medical facility. A devicemay also be sterilized using any other technique known in the art,including but not limited to beta radiation, gamma radiation, ethyleneoxide, plasma peroxide, and/or steam.

While several forms have been illustrated and described, it is not theintention of the applicant to restrict or limit the scope of theappended claims to such detail. Numerous modifications, variations,changes, substitutions, combinations, and equivalents to those forms maybe implemented and will occur to those skilled in the art withoutdeparting from the scope of the present disclosure. Moreover, thestructure of each element associated with the described forms can bealternatively described as a means for providing the function performedby the element. Also, where materials are disclosed for certaincomponents, other materials may be used. It is therefore to beunderstood that the foregoing description and the appended claims areintended to cover all such modifications, combinations, and variationsas falling within the scope of the disclosed forms. The appended claimsare intended to cover all such modifications, variations, changes,substitutions, modifications, and equivalents.

The foregoing detailed description has set forth various forms of thedevices and/or processes via the use of block diagrams, flowcharts,and/or examples. Insofar as such block diagrams, flowcharts, and/orexamples contain one or more functions and/or operations, it will beunderstood by those within the art that each function and/or operationwithin such block diagrams, flowcharts, and/or examples can beimplemented, individually and/or collectively, by a wide range ofhardware, software, firmware, or virtually any combination thereof.Those skilled in the art will recognize that some aspects of the formsdisclosed herein, in whole or in part, can be equivalently implementedin integrated circuits, as one or more computer programs running on oneor more computers (e.g., as one or more programs running on one or morecomputer systems), as one or more programs running on one or moreprocessors (e.g., as one or more programs running on one or moremicroprocessors), as firmware, or as virtually any combination thereof,and that designing the circuitry and/or writing the code for thesoftware and or firmware would be well within the skill of one ofskilled in the art in light of this disclosure. In addition, thoseskilled in the art will appreciate that the mechanisms of the subjectmatter described herein are capable of being distributed as one or moreprogram products in a variety of forms and that an illustrative form ofthe subject matter described herein applies regardless of the particulartype of signal-bearing medium used to actually carry out thedistribution.

Instructions used to program logic to perform various disclosed aspectscan be stored within a memory in the system, such as DRAM, cache, flashmemory, or other storage. Furthermore, the instructions can bedistributed via a network or by way of other computer-readable media.Thus a machine-readable medium may include any mechanism for storing ortransmitting information in a form readable by a machine (e.g., acomputer), but is not limited to, floppy diskettes, optical disks,CD-ROMs, magneto-optical disks, ROM, RAM, EPROM, EEPROM, magnetic oroptical cards, flash memory, or tangible, machine-readable storage usedin the transmission of information over the Internet via electrical,optical, acoustical, or other forms of propagated signals (e.g., carrierwaves, infrared signals, digital signals). Accordingly, thenon-transitory computer-readable medium includes any type of tangiblemachine-readable medium suitable for storing or transmitting electronicinstructions or information in a form readable by a machine (e.g., acomputer).

As used in any aspect herein, the term “control circuit” may refer to,for example, hardwired circuitry, programmable circuitry (e.g., acomputer processor comprising one or more individual instructionprocessing cores, processing unit, processor, microcontroller,microcontroller unit, controller, DSP, PLD, programmable logic array(PLA), or FPGA), state machine circuitry, firmware that storesinstructions executed by programmable circuitry, and any combinationthereof. The control circuit may, collectively or individually, beembodied as circuitry that forms part of a larger system, for example,an integrated circuit, an application-specific integrated circuit(ASIC), a system on-chip (SoC), desktop computers, laptop computers,tablet computers, servers, smart phones, etc. Accordingly, as usedherein, “control circuit” includes, but is not limited to, electricalcircuitry having at least one discrete electrical circuit, electricalcircuitry having at least one integrated circuit, electrical circuitryhaving at least one application-specific integrated circuit, electricalcircuitry forming a general-purpose computing device configured by acomputer program (e.g., a general-purpose computer configured by acomputer program which at least partially carries out processes and/ordevices described herein, or a microprocessor configured by a computerprogram which at least partially carries out processes and/or devicesdescribed herein), electrical circuitry forming a memory device (e.g.,forms of random access memory), and/or electrical circuitry forming acommunications device (e.g., a modem, communications switch, oroptical-electrical equipment). Those having skill in the art willrecognize that the subject matter described herein may be implemented inan analog or digital fashion or some combination thereof.

As used in any aspect herein, the term “logic” may refer to an app,software, firmware, and/or circuitry configured to perform any of theaforementioned operations. Software may be embodied as a softwarepackage, code, instructions, instruction sets, and/or data recorded onnon-transitory computer-readable storage medium. Firmware may beembodied as code, instructions, instruction sets, and/or data that arehard-coded (e.g., non-volatile) in memory devices.

As used in any aspect herein, the terms “component,” “system,” “module,”and the like can refer to a computer-related entity, either hardware, acombination of hardware and software, software, or software inexecution.

As used in any aspect herein, an “algorithm” refers to a self-consistentsequence of steps leading to a desired result, where a “step” refers toa manipulation of physical quantities and/or logic states which may,though need not necessarily, take the form of electrical or magneticsignals capable of being stored, transferred, combined, compared, andotherwise manipulated. It is common usage to refer to these signals asbits, values, elements, symbols, characters, terms, numbers, or thelike. These and similar terms may be associated with the appropriatephysical quantities and are merely convenient labels applied to thesequantities and/or states.

A network may include a packet-switched network. The communicationdevices may be capable of communicating with each other using a selectedpacket-switched network communications protocol. One examplecommunications protocol may include an Ethernet communications protocolwhich may be capable permitting communication using a TransmissionControl Protocol/IP. The Ethernet protocol may comply or be compatiblewith the Ethernet standard published by the Institute of Electrical andElectronics Engineers (IEEE) titled “IEEE 802.3 Standard,” published inDecember 2008 and/or later versions of this standard. Alternatively oradditionally, the communication devices may be capable of communicatingwith each other using an X.25 communications protocol. The X.25communications protocol may comply or be compatible with a standardpromulgated by the International TelecommunicationUnion-Telecommunication Standardization Sector (ITU-T). Alternatively oradditionally, the communication devices may be capable of communicatingwith each other using a frame relay communications protocol. The framerelay communications protocol may comply or be compatible with astandard promulgated by Consultative Committee for InternationalTelegraph and Telephone (CCITT) and/or the American National StandardsInstitute (ANSI). Alternatively or additionally, the transceivers may becapable of communicating with each other using an Asynchronous TransferMode (ATM) communications protocol. The ATM communications protocol maycomply or be compatible with an ATM standard published by the ATM Forum,titled “ATM-MPLS Network Interworking 2.0,” published August 2001,and/or later versions of this standard. Of course, different and/orafter-developed connection-oriented network communication protocols areequally contemplated herein.

Unless specifically stated otherwise as apparent from the foregoingdisclosure, it is appreciated that, throughout the foregoing disclosure,discussions using terms such as “processing,” “computing,”“calculating,” “determining,” “displaying,” or the like, refer to theaction and processes of a computer system, or similar electroniccomputing device, that manipulates and transforms data represented asphysical (electronic) quantities within the computer system's registersand memories into other data similarly represented as physicalquantities within the computer system memories or registers or othersuch information storage, transmission, or display devices.

One or more components may be referred to herein as “configured to,”“configurable to,” “operable/operative to,” “adapted/adaptable,” “ableto,” “conformable/conformed to,” etc. Those skilled in the art willrecognize that “configured to” can generally encompass active-statecomponents, inactive-state components, and/or standby-state components,unless context requires otherwise.

With respect to the appended claims, those skilled in the art willappreciate that recited operations therein may generally be performed inany order. Also, although various operational flow diagrams arepresented in a sequence(s), it should be understood that the variousoperations may be performed in other orders than those which areillustrated or may be performed concurrently. Examples of such alternateorderings may include overlapping, interleaved, interrupted, reordered,incremental, preparatory, supplemental, simultaneous, reverse, or othervariant orderings, unless context dictates otherwise. Furthermore, termslike “responsive to,” “related to,” or other past-tense adjectives aregenerally not intended to exclude such variants, unless context dictatesotherwise.

It is worthy to note that any reference to “one aspect,” “an aspect,”“an exemplification,” “one exemplification,” and the like means that aparticular feature, structure, or characteristic described in connectionwith the aspect is included in at least one aspect. Thus, appearances ofthe phrases “in one aspect,” “in an aspect,” “in an exemplification,”and “in one exemplification” in various places throughout thespecification are not necessarily all referring to the same aspect.Furthermore, the particular features, structures, or characteristics maybe combined in any suitable manner in one or more aspects.

While this invention has been described as having exemplary designs, thepresent invention may be further modified within the spirit and scope ofthe disclosure. This application is therefore intended to cover anyvariations, uses, or adaptations of the invention using its generalprinciples.

Any patent, publication, or other disclosure material, in whole or inpart, that is said to be incorporated by reference herein isincorporated herein only to the extent that the incorporated materialsdo not conflict with existing definitions, statements, or otherdisclosure material set forth in this disclosure. As such, and to theextent necessary, the disclosure as explicitly set forth hereinsupersedes any conflicting material incorporated herein by reference.Any material, or portion thereof, that is said to be incorporated byreference herein, but which conflicts with existing definitions,statements, or other disclosure material set forth herein will only beincorporated to the extent that no conflict arises between thatincorporated material and the existing disclosure material.

What is claimed is:
 1. A method for adjusting the operation of a clipapplier using machine learning in a surgical suite, wherein said methodcomprises: gathering data during surgical procedures, wherein thesurgical procedures include the use of a clip applier comprising acrimping drive configured to be mechanically advanced through a crimpingstroke; analyzing the gathered data to determine an appropriateoperational adjustment of the clip applier; and adjusting the operationof the clip applier to improve the operation of the clip applier.
 2. Themethod of claim 1, wherein gathering data comprises storing data in asurgical hub.
 3. The method of claim 1, wherein the clip applier isattached to a surgical robot and is configured to be operated manuallyby a clinician.
 4. The method of claim 1, wherein adjusting theoperation of the clip applier comprises adjusting the length of thecrimping stroke of the crimping drive.
 5. The method of claim 1, whereinadjusting the operation of the clip applier comprises adjusting thespeed of the crimping stroke of the crimping drive.
 6. The method ofclaim 1, wherein gathering data comprises monitoring each crimpingstroke during use of the clip applier using a crimping drive detectioncircuit.
 7. The method of claim 1, wherein adjusting the operation ofthe clip applier comprises placing a power control program of a surgicalrobot to which the clip applier is attached in a limp mode.
 8. Themethod of claim 1, wherein gathering data comprises accessing existinginformation based on previous operations.
 9. A method for adjustingcontrol parameters of a clip applier using a surgical hub, wherein saidmethod comprises: gathering data during surgical procedures, whereineach surgical procedure includes the use of a clip applier comprising acrimping drive configured to be advanced through a crimping stroke;evaluating the gathered data to determine the appropriate operation ofthe clip applier; operating the clip applier; monitoring the operationof the clip applier; determining if the operation of the clip applierneeds to be adjusted based on the evaluated data; and adjusting theoperation of the clip applier.
 10. The method of claim 9, whereingathering data comprises storing data in a surgical hub system.
 11. Themethod of claim 9, wherein adjusting the operation of the clip appliercomprises adjusting a power control program configured to operate amotor.
 12. The method of claim 11, wherein the motor mechanicallyadvances the crimping drive, and wherein the adjustment compriseschanging the length of the crimping stroke of the crimping drive. 13.The method of claim 11, wherein the motor mechanically advances thecrimping drive, and wherein the adjustment comprises adjusting the speedof the crimping stroke of the crimping drive.
 14. The method of claim 9,wherein gathering data comprises monitoring each crimping stroke duringthe use of the clip applier using a crimping drive detection circuit.15. The method of claim 9, wherein adjusting the operation of the clipapplier comprises placing a power control program to which the clipapplier is attached in a limp mode.
 16. The method of claim 9, whereingathering data comprises accessing existing information based onprevious operations.
 17. The method of claim 9, wherein determining ifthe operation of the clip applier needs to be adjusted is based on theanticipated crimping stroke length and the actual crimping strokelength.
 18. A method for adjusting the operation of a clip applier usinga surgical hub, wherein the clip applier comprises an end effector and afiring system comprising a motor, wherein the end effector comprises acrimping drive and a crimping drive detection circuit, wherein thefiring system is configured to apply control motions to the crimpingdrive to advance the crimping drive through a crimping stroke to crimp aclip around patient tissue, wherein the crimping drive detection circuitis configured to detect a parameter of the crimping drive during thecrimping stroke, and wherein the method for adjusting control parametersof the clip applier comprises: evaluating data originating from thedetection circuit and the surgical hub; determining if the controlmotions of the clip applier need to be adjusted based on the evaluateddata; and adjusting the operation of the clip applier.
 19. The method ofclaim 18, wherein the clip applier is attached to a surgical robot andis configured to be operated manually by a clinician.
 20. The method ofclaim 18, wherein the data from the surgical hub comprises data gatheredduring previous operations.